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OpenTrials
Completed

NCT Number: NCT00523991

Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).

A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus Pro Re Nata (PRN) albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

205.365.1103 Boehringer Ingelheim Investigational Site, Gilly, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All subjects must have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline criteria:

post-bronchodilator Forced Expiratory Volume in one Second/Forced Vital Capacity (FEV1/FVC) ratio < 70% (visit 1).

Subjects must be GOLD Stage II and have a post-bronchodilator FEV1 >50% and < 80% of predicted normal (visit 1). Subjects must be current or ex-smokers with a smoking history of >=10 pack years.

Subjects must have a Medical Research Council (MRC) dyspnea score >= 2.

Exclusion criteria

Subjects who have been treated with maintenance medications for chronic respiratory disease within six months prior to screening.

Subjects with significant diseases other than COPD. Subjects on chronic systemic corticosteroids.

Subjects with any upper and/or lower respiratory tract infection or COPD exacerbation in the 6 weeks prior to the initial visit 1 or during the screening period prior to visit 3 Subjects with a recent (past 6 months) myocardial infarction, any unstable or life threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year.

Treatment and study plan

Tiotropium

Drug

Oral inhalation once daily of 18mcg tiotropium via handihaler

Placebo

Drug

Oral inhalation once daily of placebo matching tiotropium via handihaler

Primary outcomes

  1. Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)

    Time frame: baseline, week 24

    Change = Week 24 Value - Baseline Value

Secondary outcomes

  1. Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)

    Time frame: Baseline

    Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  2. Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)

    Time frame: Baseline, week 8

    Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  3. Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)

    Time frame: Baseline, week 16

    Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  4. Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)

    Time frame: Baseline, week 24

    Trough FEV1 defined as the FEV1 measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FEV1 was the pre-treatment FEV1 measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  5. Peak Forced Expiratory Volume in 1 Second (Baseline)

    Time frame: Baseline

    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.

  6. Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)

    Time frame: Baseline, week 8

    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

  7. Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)

    Time frame: Baseline, week 16

    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

  8. Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)

    Time frame: Baseline, week 24

    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

  9. Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)

    Time frame: Baseline

    Forced expiratory volume in 1 second (baseline, pre-dose)

  10. Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)

    Time frame: baseline, 30 minutes

    Forced expiratory volume in 1 second (baseline, 30 minutes)

  11. Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)

    Time frame: baseline, 60 minutes

    Forced expiratory volume in 1 second (baseline, 60 minutes)

  12. Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)

    Time frame: Baseline, 120 minutes

    Forced expiratory volume in 1 second (baseline, 120 minutes)

  13. Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)

    Time frame: Baseline, 180 minutes

    Forced expiratory volume in 1 second (baseline, 180 minutes)

  14. Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)

    Time frame: baseline, week 8, pre-dose

    Change from baseline in forced expiratory volume in 1 second (at week 8, pre-dose)

  15. Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)

    Time frame: Baseline, week 8, 30 minutes

    Change from baseline in forced expiratory volume in 1 second (at week 8, 30 minutes)

  16. Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)

    Time frame: baseline, week 8, 60 minutes

    Change from baseline in forced expiratory volume in 1 second (at week 8, 60 minutes)

  17. Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)

    Time frame: baseline, week 8, 120 minutes

    Change from baseline in forced expiratory volume in 1 second (at week 8, 120 minutes)

  18. Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)

    Time frame: baseline, week 8, 180 minutes

    Change from baseline in forced expiratory volume in 1 second (at week 8, 180 minutes)

  19. Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)

    Time frame: baseline, week 16, pre-dose

    Change from baseline in forced expiratory volume in 1 second (at week 16, pre-dose)

  20. Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)

    Time frame: Baseline, week 16, 30 minutes

    Change from baseline in peak forced expiratory volume in 1 second (at week 16, 30 minutes)

  21. Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)

    Time frame: baseline, week 16, 60 minutes

    Change from baseline in peak forced expiratory volume in 1 second (at week 16, 60 minutes)

  22. Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)

    Time frame: baseline, week 16, 120 minutes

    Change from baseline in peak forced expiratory volume in 1 second (at week 16, 120 minutes)

  23. Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)

    Time frame: baseline, week 16, 180 minutes

    Change from baseline in peak forced expiratory volume in 1 second (at week 16, 180 minutes)

  24. Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)

    Time frame: baseline, week 24, pre-dose

    Change from baseline in peak forced expiratory volume in 1 second (at week 24, pre-dose)

  25. Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)

    Time frame: baseline, week 24, 30 minutes

    Change from baseline in peak forced expiratory volume in 1 second (at week 24, 30 minutes)

  26. Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)

    Time frame: baseline, week 24, 60 minutes

    Change from baseline in peak forced expiratory volume in 1 second (at week 24, 60 minutes)

  27. Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)

    Time frame: baseline, week 24, 120 minutes

    Change from baseline in peak forced expiratory volume in 1 second (at week 24, 120 minutes)

  28. Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)

    Time frame: baseline, week 24, 180 minutes

    Change from baseline in peak forced expiratory volume in 1 second (at week 24, 180 minutes)

  29. FVC AUC0-3 at Baseline

    Time frame: baseline

    Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)

  30. FVC AUC0-3 at Week 8 Minus Baseline

    Time frame: baseline, week 8

    Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 8)

  31. FVC AUC0-3 at Week 16 Minus Baseline

    Time frame: baseline, week 16

    Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h)(week 16)

  32. FVC AUC0-3 at Week 24 Minus Baseline

    Time frame: baseline, week 24

    Change from baseline in Forced vital capacity (FVC) area under the curve from 0-3 hours (AUC0-3h) (week 24)

  33. Trough Forced Vital Capacity (Baseline)

    Time frame: baseline

    Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  34. Change From Baseline in Trough Forced Vital Capacity (at Week 8)

    Time frame: baseline, week 8

    Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  35. Change From Baseline in Trough Forced Vital Capacity (at Week 16)

    Time frame: baseline, week 16

    Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  36. Change From Baseline in Trough Forced Vital Capacity (at Week 24)

    Time frame: baseline, week 24

    Trough FVC defined as the FVC measured at 10 minutes prior to the end of the dosing interval, approximately 24 hours post drug administration. Baseline FVC was the pre-treatment FVC measured at Week 0 in the morning 10 minutes prior to the administration of the first dose of the study medication.

  37. Peak Forced Vital Capacity (FVC) (Baseline)

    Time frame: baseline

    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1.

  38. Change From Baseline in Peak Forced Vital Capacity (at Week 8)

    Time frame: baseline, week 8

    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

  39. Change From Baseline in Peak Forced Vital Capacity (at Week 16)

    Time frame: baseline, week 16

    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

  40. Change From Baseline in Peak Forced Vital Capacity (at Week 24)

    Time frame: baseline, week 24

    Peak FEV1 defined as the maximum of the observed values over 30, 60, 120, and 180 minutes post-dose for FEV1. Peak response was defined as the change from baseline to the peak FEV1 value at the final visit.

  41. Forced Vital Capacity (Baseline, Pre-dose)

    Time frame: baseline

    Forced vital capacity (baseline, pre-dose)

  42. Forced Vital Capacity (Baseline, 30 Minutes)

    Time frame: baseline, 30 minutes

    Forced vital capacity (baseline, 30 minutes)

  43. Forced Vital Capacity (Baseline, 60 Minutes)

    Time frame: baseline, 60 minutes

    Forced vital capacity (baseline, 60 minutes)

  44. Forced Vital Capacity (Baseline, 120 Minutes)

    Time frame: baseline, 120 minutes

    Forced vital capacity (baseline, 120 minutes)

  45. Forced Vital Capacity (Baseline, 180 Minutes)

    Time frame: baseline, 180 minutes

    Forced vital capacity (baseline, 180 minutes)

  46. Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)

    Time frame: baseline, week 8, pre-dose

    Change from baseline in forced vital capacity (week 8, pre-dose)

  47. Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)

    Time frame: baseline, week 8, 30 minutes

    Change from baseline in forced vital capacity (week 8, 30 minutes)

  48. Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)

    Time frame: baseline, week 8, 60 minutes

    Change from baseline in forced vital capacity (week 8, 60 minutes)

  49. Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)

    Time frame: baseline, week 8, 120 minutes

    Change from baseline in forced vital capacity (week 8, 120 minutes)

  50. Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)

    Time frame: baseline, week 8, 180 minutes

    Change from baseline in forced vital capacity (week 8, 180 minutes)

  51. Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)

    Time frame: baseline, week 16, pre-dose

    Change from baseline in forced vital capacity (week 16, pre-dose)

  52. Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)

    Time frame: baseline, week 16, 30 minutes

    Change from baseline in forced vital capacity (week 16, 30 minutes)

  53. Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)

    Time frame: baseline, week 16, 60 minutes

    Change from baseline in forced vital capacity (week 16, 60 minutes)

  54. Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)

    Time frame: baseline, week 16, 120 minutes

    Change from baseline in forced vital capacity (week 16, 120 minutes)

  55. Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)

    Time frame: baseline, week 16, 180 minutes

    Change from baseline in forced vital capacity (week 16, 180 minutes)

  56. Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)

    Time frame: baseline, week 24, pre-dose

    Change from baseline in forced vital capacity (week 24, pre-dose)

  57. Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)

    Time frame: baseline, week 24, 30 minutes

    Change from baseline in forced vital capacity (week 24, 30 minutes)

  58. Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)

    Time frame: baseline, week 24, 60 minutes

    Change from baseline in forced vital capacity (week 24, 60 minutes)

  59. Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)

    Time frame: baseline, week 24, 120 minutes

    Change from baseline in forced vital capacity (week 24, 120 minutes)

  60. Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)

    Time frame: baseline, week 24, 180 minutes

    Change from baseline in forced vital capacity (week 24, 180 minutes)

  61. Albuterol Use p.r.n. (Baseline)

    Time frame: baseline

    Number of days that participants used albuterol prn per week

  62. Change From Baseline in Albuterol Use p.r.n. - (Week 4)

    Time frame: baseline, week 4

    Difference in number of days that participants used albuterol prn per week between week 4 and baseline

  63. Change From Baseline in Albuterol Use p.r.n. - (Week 8)

    Time frame: baseline, week 8

    Difference in number of days that participants used albuterol prn per week between week 8 and baseline

  64. Change From Baseline in Albuterol Use p.r.n. -(Week 12)

    Time frame: baseline, week 12

    Difference in number of days that participants used albuterol prn per week between week 12 and baseline

  65. Change From Baseline in Albuterol Use p.r.n. - (Week 16)

    Time frame: baseline, week 16

    Difference in number of days that participants used albuterol prn per week between week 16 and baseline

  66. Change From Baseline in Albuterol Use p.r.n. -(Week 20)

    Time frame: baseline, week 20

    Difference in number of days that participants used albuterol prn per week between week 20 and baseline

  67. Change From Baseline in Albuterol Use p.r.n. - (Week 24)

    Time frame: baseline, week 24

    Difference in number of days that participants used albuterol prn per week between week 24 and baseline

  68. Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)

    Time frame: baseline

    The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.

    Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

  69. Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)

    Time frame: week 12

    The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.

    Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

  70. Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)

    Time frame: week 24

    The physician's global assessment reflected the physician's opinion of the participant's overall clinical condition with respect to COPD. The evaluation was based on the participant's use of concomitant medications, as well as the number and severity of COPD exacerbations and related emergency room visits and/or hospitalizations since the last visit. The frequency and severity of symptoms ( cough, dyspnea, wheezing) and the impact of these on the participant's ability to exercise were considered.

    Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

  71. Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)

    Time frame: baseline

    The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.

    Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

  72. Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)

    Time frame: week 12

    The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.

    Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

  73. Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)

    Time frame: week 24

    The patient's global assessment was based on the subject's need to take additional medications for breathing, their need for emergency room or hospital visits for COPD, and severity and amount of coughing, wheezing, and/or breathing discomfort experienced, and the impact of these symptoms on the subject's ability to exercise and perform daily activities.

    Range: 1-2 = Poor, 3-4 = Fair 5-6 = Good, 7-8 = Excellent.

  74. Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)

    Time frame: baseline

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

    Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.

  75. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)

    Time frame: baseline, week 4

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.

  76. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)

    Time frame: baseline, week 8

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.

  77. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)

    Time frame: baseline, week 12

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.

  78. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)

    Time frame: baseline, week 16

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.

  79. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)

    Time frame: baseline, week 20

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.

  80. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)

    Time frame: baseline, week 24

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.

  81. Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health

    Time frame: baseline

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

    Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.

  82. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)

    Time frame: baseline, week 4

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.

  83. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)

    Time frame: baseline, week 8

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.

  84. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)

    Time frame: baseline, week 12

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.

  85. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)

    Time frame: baseline, week 16

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.

  86. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)

    Time frame: baseline, week 20

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.

  87. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)

    Time frame: baseline, week 24

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.

  88. Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)

    Time frame: baseline

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

    Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.

  89. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)

    Time frame: baseline, week 4

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.

  90. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)

    Time frame: baseline, week 8

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.

  91. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)

    Time frame: baseline, week 12

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.

  92. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)

    Time frame: baseline, week 16

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.

  93. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)

    Time frame: baseline, week 20

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.

  94. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)

    Time frame: baseline, week 24

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.

  95. Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)

    Time frame: baseline

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment.

    Absenteeism, Presenteeism, Work productivity loss, Activity Impairment Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment.

  96. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)

    Time frame: baseline, week 4

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 4 and baseline.

  97. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)

    Time frame: baseline, week 8

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 8 and baseline.

  98. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)

    Time frame: baseline, week 12

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 12 and baseline.

  99. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)

    Time frame: baseline, week 16

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 16 and baseline.

  100. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)

    Time frame: baseline, week 20

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 20 and baseline.

  101. Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)

    Time frame: baseline, week 24

    WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Scores range from 0 to 100 for each of the above 4 types; higher scores indicate greater impairment. Difference refers to change in scale between week 24 and baseline.

  102. Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day

    Time frame: baseline

    Light intensity is less than three metabolic equivalents.

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm.

  103. Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day

    Time frame: baseline, week 4

    Light intensity is less than three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm

  104. Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day

    Time frame: baseline, week 8

    Light intensity is less than three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm

  105. Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day

    Time frame: baseline, week 12

    Light intensity defined as less than three metabolic equivalents.

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm

  106. Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day

    Time frame: baseline, week 16

    Light intensity is less than three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm

  107. Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day

    Time frame: baseline, week 20

    Light intensity is less than three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm

  108. Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day

    Time frame: baseline, week 24

    Light intensity is less than three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm

  109. Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day

    Time frame: baseline

    Moderate or higher intensity is greater than or equal to three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm

  110. Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day

    Time frame: baseline, week 4

    Moderate or higher intensity is greater than or equal to three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm

  111. Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day

    Time frame: baseline, week 8

    Moderate or higher intensity is greater than or equal to three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm

  112. Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day

    Time frame: baseline, week 12

    Moderate or higher intensity is greater than or equal to three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm

  113. Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day

    Time frame: baseline, week 16

    Moderate or higher intensity is greater than or equal to three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm

  114. Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day

    Time frame: baseline, week 20

    Moderate or higher intensity is greater than or equal to three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm

  115. Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day

    Time frame: baseline, week 24

    Moderate or higher intensity is greater than or equal to three metabolic equivalents

    Metabolic equivalent threshold (MET): Unit used to estimate the metabolic cost of physical activity, in terms of multiples of the subject's resting metabolic rate. One metabolic equivalent is, by convention, 3.5 ml of O2 uptake per minute per kilogram body weight, and theoretically approximates the resting metabolic rate.

    ln in measure value unit means natural logarithm

  116. Number of Participants With Healthy Lifestyle (Baseline)

    Time frame: baseline

    Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

  117. Number of Participants With Healthy Lifestyle (Week 4)

    Time frame: week 4

    Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

  118. Number of Participants With Healthy Lifestyle (Week 8)

    Time frame: week 8

    Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

  119. Number of Participants With Healthy Lifestyle (Week 12)

    Time frame: week 12

    Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

  120. Number of Participants With Healthy Lifestyle (Week 16)

    Time frame: week 16

    Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

  121. Number of Participants With Healthy Lifestyle (Week 20)

    Time frame: week 20

    Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

  122. Number of Participants With Healthy Lifestyle (Week 24)

    Time frame: week 24

    Healthy lifestyle defined as 30 minutes of activity > 3 metabolic equivalent levels for 70% of eligible days. Two categories: Yes, no

  123. Active Energy Expenditure (Baseline)

    Time frame: baseline

    The amount of energy (kcal/day) that a person uses while physically active.

  124. Change From Baseline in Active Energy Expenditure (Week 4)

    Time frame: baseline, week 4

    The amount of energy (kcal/day) that a person uses while physically active.

  125. Change From Baseline in Active Energy Expenditure (Week 8)

    Time frame: baseline, week 8

    The amount of energy (kcal/day) that a person uses while physically active.

  126. Change From Baseline in Active Energy Expenditure (Week 12)

    Time frame: baseline, week 12

    The amount of energy (kcal/day) that a person uses while physically active.

  127. Change From Baseline in Active Energy Expenditure (Week 16)

    Time frame: baseline, week 16

    The amount of energy (kcal/day) that a person uses while physically active.

  128. Change From Baseline in Active Energy Expenditure (Week 20)

    Time frame: baseline, week 20

    The amount of energy (kcal/day) that a person uses while physically active.

  129. Change From Baseline in Active Energy Expenditure (Week 24)

    Time frame: baseline, week 24

    The amount of energy (kcal/day) that a person uses while physically active.

  130. Number of Steps Per Day (Baseline)

    Time frame: baseline

    Number of steps per day (baseline)

  131. Change From Baseline in Number of Steps Per Day (Week 4)

    Time frame: baseline, week 4

    Change from baseline in number of steps per day (week 4)

  132. Change From Baseline in Number of Steps Per Day(Week 8)

    Time frame: baseline, week 8

    Change from baseline in number of steps per day (week 8)

  133. Change From Baseline in Number of Steps Per Day (Week 12)

    Time frame: baseline, week 12

    Change from baseline in Number of steps per day (week 12)

  134. Change From Baseline in Number of Steps Per Day (Week 16)

    Time frame: baseline, week 16

    Change from baseline in number of steps per day (week 16)

  135. Change From Baseline in Number of Steps Per Day (Week 20)

    Time frame: baseline, week 20

    Change from baseline in number of steps per day (week 20)

  136. Change From Baseline in Number of Steps Per Day (Week 24)

    Time frame: baseline, week 24

    Change from baseline in number of steps per day (week 24)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Pfizer

Registry information

Official study title

A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy

Important dates

Study start
2007
Primary completion
2010
First posted
Sep 3, 2007
Registry last updated
May 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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