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Completed

NCT Number: NCT00400153

Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)

The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1012.56.54001 Centro Médico de la Dra. De Salvo, Capital Federal, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%).

Exclusion criteria

Patients with significant diseases other than COPD that may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study, with a history of asthma or allergic rhinitis, who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy or using oral corticosteroid me dication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day will be excluded.

Treatment and study plan

Atrovent Respimat (20 mcg)

Drug

COMBIVENT MDI (36/206 mcg)

Drug

Combivent Respimat (20 mcg/100 mcg)

Drug

Placebo via corresponding inhaler for blinding purposes

Drug

Primary outcomes

  1. FEV1 AUC0-6 at Day 85

    Time frame: Before drug administration to 6 hours after drug administration on Day 85

    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85

  2. FEV1 AUC0-4 at Day 85

    Time frame: Before drug administration to 4 hours after drug administration on Day 85

    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85

  3. FEV1 AUC4-6 at Day 85

    Time frame: Between 4 hours and 6 hours after drug administration on Day 85

    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85

Secondary outcomes

  1. FEV1 AUC0-6 at Day 1

    Time frame: Before drug administration to 6 hours after drug administration on Day 1

    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1

  2. FEV1 AUC0-6 at Day 29

    Time frame: Before drug administration to 6 hours after drug administration on Day 29

    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29

  3. FEV1 AUC0-6 at Day 57

    Time frame: Before drug administration to 6 hours after drug administration on Day 57

    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57

  4. FEV1 AUC0-4 at Day 1

    Time frame: Before drug administration to 4 hours after drug administration on Day 1

    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1

  5. FEV1 AUC0-4 at Day 29

    Time frame: Before drug administration to 4 hours after drug administration on Day 29

    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29

  6. FEV1 AUC0-4 at Day 57

    Time frame: Before drug administration to 4 hours after drug administration on Day 57

    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57

  7. FEV1 AUC4-6 at Day 1

    Time frame: Between 4 hours and 6 hours after drug administration on Day 1

    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1

  8. FEV1 AUC4-6 at Day 29

    Time frame: Between 4 hours and 6 hours after drug administration on Day 29

    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29

  9. FEV1 AUC4-6 at Day 57

    Time frame: Between 4 hours and 6 hours after drug administration on Day 57

    Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57

  10. Peak FEV1 Response at Day 1

    Time frame: Within the first 2-hour post-treatment interval on Day 1

    Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1

  11. Peak FEV1 Response at Day 29

    Time frame: Within the first 2-hour post-treatment interval on Day 29

    Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29

  12. Peak FEV1 Response at Day 57

    Time frame: Within the first 2-hour post-treatment interval on Day 57

    Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57

  13. Peak FEV1 Response at Day 85

    Time frame: Within the first 2-hour post-treatment interval on Day 85

    Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85

  14. Time to Onset of Therapeutic FEV1 Response at Day 1

    Time frame: Within the first 2-hour post-treatment interval at Day 1

    Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 1

  15. Time to Onset of Therapeutic FEV1 Response at Day 29

    Time frame: Within the first 2-hour post-treatment interval at Day 29

    Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 29

  16. Time to Onset of Therapeutic FEV1 Response at Day 57

    Time frame: Within the first 2-hour post-treatment interval at Day 57

    Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 57

  17. Time to Onset of Therapeutic FEV1 Response at Day 85

    Time frame: Within the first 2-hour post-treatment interval at Day 85

    Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 85

  18. Duration of Therapeutic FEV1 Response at Day 1

    Time frame: During the 6-hour observation period after drug administration at Day 1

    The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 1

  19. Duration of Therapeutic FEV1 Response at Day 29

    Time frame: During the 6-hour observation period after drug administration at Day 29

    The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 29

  20. Duration of Therapeutic FEV1 Response at Day 57

    Time frame: During the 6-hour observation period after drug administration at Day 57

    The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 57

  21. Duration of Therapeutic FEV1 Response at Day 85

    Time frame: During the 6-hour observation period after drug administration at Day 85

    The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 85

  22. Time to Peak FEV1 Response at Day 1

    Time frame: Within the 6-hour post-treatment observation period at Day 1

    The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 1

  23. Time to Peak FEV1 Response at Day 29

    Time frame: Within the 6-hour post-treatment observation period at Day 29

    The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 29

  24. Time to Peak FEV1 Response at Day 57

    Time frame: Within the 6-hour post-treatment observation period at Day 57

    The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 57

  25. Time to Peak FEV1 Response at Day 85

    Time frame: Within the 6-hour post-treatment observation period at Day 85

    The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 85

  26. FVC AUC0-6 at Day 1

    Time frame: Before drug administration to 6 hours after drug administration at Day 1

    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1

  27. FVC AUC0-6 at Day 29

    Time frame: Before drug administration to 6 hours after drug administration at Day 29

    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29

  28. FVC AUC0-6 at Day 57

    Time frame: Before drug administration to 6 hours after drug administration on Day 57

    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57

  29. FVC AUC0-6 at Day 85

    Time frame: Before drug administration to 6 hours after drug administration on Day 85

    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85

  30. FVC AUC0-4 at Day 1

    Time frame: Before drug administration to 4 hours after drug administration on Day 1

    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1

  31. FVC AUC0-4 at Day 29

    Time frame: Before drug administration to 4 hours after drug administration on Day 29

    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29

  32. FVC AUC0-4 at Day 57

    Time frame: Before drug administration to 4 hours after drug administration on Day 57

    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57

  33. FVC AUC0-4 at Day 85

    Time frame: Before drug administration to 4 hours after drug administration on Day 85

    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85

  34. FVC AUC4-6 at Day 1

    Time frame: Between 4 hours and 6 hours after drug administration on Day 1

    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1

  35. FVC AUC4-6 at Day 29

    Time frame: Between 4 hours and 6 hours after drug administration on Day 29

    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29

  36. FVC AUC4-6 at Day 57

    Time frame: Between 4 hours and 6 hours after drug administration on Day 57

    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57

  37. FVC AUC4-6 at Day 85

    Time frame: Between 4 hours and 6 hours after drug administration on Day 85

    Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85

  38. Peak FVC Response at Day 1

    Time frame: Within the first 2-hour post-treatment interval at Day 1

    Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1

  39. Peak FVC Response at Day 29

    Time frame: Within the first 2-hour post-treatment interval at Day 29

    Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29

  40. Peak FVC Response at Day 57

    Time frame: Within the first 2-hour post-treatment interval at Day 57

    Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57

  41. Peak FVC Response at Day 85

    Time frame: Within the first 2-hour post-treatment interval at Day 85

    Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85

  42. Rescue Medication Use on Pulmonary Test Day 1

    Time frame: During the 6-hour pulmonary function testing after drug administration on Day 1

    Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1

  43. Rescue Medication Use on Pulmonary Test Day 29

    Time frame: During the 6-hour pulmonary function testing after drug administration on Day 29

    Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29

  44. Rescue Medication Use on Pulmonary Test Day 57

    Time frame: During the 6-hour pulmonary function testing after drug administration on Day 57

    Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57

  45. Rescue Medication Use on Pulmonary Test Day 85

    Time frame: During the 6-hour pulmonary function testing after drug administration on Day 85

    Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85

  46. Night-time Rescue Medication Use

    Time frame: During the 2-week baseline washout period and the 12-week treatment period

    The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period)

  47. Daytime Rescue Medication Use

    Time frame: During the 2-week baseline washout period and the 12-week treatment period

    The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)

  48. Night-time Symptom Score

    Time frame: During the 2-week baseline washout period and the 12-week treatment period

    The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period).

    Night-time COPD symptoms: 0=none 1=some - slept well 2=woke once 3=woke several times 4=woke most of night

  49. Daytime Symptom Score

    Time frame: During the 2-week baseline washout period and the 12-week treatment period

    The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period).

    Daytime COPD symptoms: 0=none 1=occasional 2=frequent, no interference with activities 3=most of day, interference with activities 4=prevent working and activities

  50. Trough Peak Expiratory Flow Rate (PEFR)

    Time frame: During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication

    The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)

  51. Physician's Global Evaluation Score on Pulmonary Function Testing Day 29

    Time frame: Prior to pulmonary function test on Day 29

    Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.

    Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.

  52. Physician's Global Evaluation Score on Pulmonary Function Testing Day 57

    Time frame: Prior to pulmonary function test on Day 57

    Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.

    Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.

  53. Physician's Global Evaluation Score on Pulmonary Function Testing Day 85

    Time frame: Prior to pulmonary function test on Day 85

    Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.

    Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.

  54. Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period

    Time frame: During the 12-week on-treatment period

    COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.

  55. COPD Exacerbation Rate During the On-treatment Period

    Time frame: During the 12-week on-treatment period

    Proportion of patients experiencing a COPD exacerbation per patient year. COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.

  56. COPD Exacerbation During the On-treatment Period

    Time frame: During the 12-week on-treatment period

    COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.

  57. Frequency Distribution of Satisfaction Rating With Inhaler Attributes

    Time frame: 12 weeks

  58. Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine

    Time frame: 12 weeks

    Patients rated their response on a seven point Likert scale:

    1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

  59. Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung

    Time frame: 12 weeks

    Patients rated their response on a seven point Likert scale:

    1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

  60. Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left

    Time frame: 12 weeks

    Patients rated their response on a seven point Likert scale:

    1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

  61. Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably

    Time frame: 12 weeks

    Patients rated their response on a seven point Likert scale:

    1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

  62. Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler

    Time frame: 12 weeks

    Patients rated their response on a seven point Likert scale:

    1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

  63. Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use

    Time frame: 12 weeks

    Patients rated their response on a seven point Likert scale:

    1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

  64. Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable

    Time frame: 12 weeks

    Patients rated their response on a seven point Likert scale:

    1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

  65. Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler

    Time frame: 12 weeks

    Patients rated their response on a seven point Likert scale:

    1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

  66. Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler

    Time frame: 12 weeks

    Patients rated their response on a seven point Likert scale:

    1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

  67. Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler

    Time frame: 12 weeks

    Patients rated their response on a seven point Likert scale:

    1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.

  68. Device Preference (Respimat or MDI)

    Time frame: 12 weeks

    Frequency of patients due to device preference

  69. Rating of Action of Turning Clear Base of Respimat

    Time frame: 12 weeks

    Frequency of patients due to rating of action of turning clear base of Respimat

  70. Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State

    Time frame: Before drug administration to 6 hours after drug administration on Day 29

    Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).

  71. Noncompartmental Parameters of Albuterol at Steady State

    Time frame: Before drug administration to 6 hours after drug administration on Day 29

    Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).

  72. Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours

    Time frame: Before drug administration to 2 hours after drug administration on Day 29

    Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-2, ss

  73. Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours

    Time frame: Before drug administration to 2 hours after drug administration on Day 29

    Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0-2,ss.

  74. Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours

    Time frame: Before drug administration to 6 hours after drug administration on Day 26

    Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-6,ss

  75. Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours

    Time frame: Before drug administration to 6 hours after drug administration on Day 29

    Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0-6, ss

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)

Important dates

Study start
2006
Primary completion
2008
First posted
Nov 16, 2006
Registry last updated
Jun 13, 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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