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Completed

NCT Number: NCT00387088

Tiotropium / Respimat One Year Study in COPD.

The objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the Respimat inhaler in patients with COPD. Specifically, the study will examine the effect of treatment on COPD exacerbations.

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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

205.372.61002 Woolcock Institute of Medical Research, Glebe, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female
  • At least 40 years old
  • Smoker or ex-smoker
  • Smoking history > 10 pack-years
  • Forced Expiratory Volume in 1 Second (FEV1) < 60% predicted

Exclusion criteria

  • Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
  • History of asthma or allergic conditions.
  • Malignancy requiring treatment within past 5 years
  • Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
  • Known active tuberculosis
  • Known hypersensitivity to anticholinergic drugs.

Treatment and study plan

Respimat

Device

Tiotropium

Drug

Primary outcomes

  1. Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 337

    Time frame: Baseline and Day 337

    Trough FEV1 is defined as the FEV1 measured at the -10 min time point at the end of the dosing interval (24 h post drug administration).

  2. Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

    Time frame: During actual study treatment period (planned Day 1 to Day 337)

    Time to first COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation.

Secondary outcomes

  1. Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29

    Time frame: Baseline and Day 29

    Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.

  2. Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 169

    Time frame: Baseline and Day 169

    Trough FEV1 is the mean volume of air that can be forced out in one second after taking a deep breath approximately 24 hours after the last administration of study drug.

  3. Number of COPD Exacerbations Per Patient - Exposure Adjusted

    Time frame: During actual study treatment period (planned Day 1 to Day 337)

    Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. number of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)

  4. Number of COPD Exacerbations Per Patient - naïve Estimate

    Time frame: During actual study treatment period (planned Day 1 to Day 337)

    Number of COPD exacerbations (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)

  5. Number of Patients With at Least One COPD Exacerbation

    Time frame: During actual study treatment period (planned Day 1 to Day 337)

    Number of patients with at least one COPD exacerbation (defined as a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)

  6. Time to First Hospitalisation for COPD Exacerbation

    Time frame: During actual study treatment period (planned Day 1 to Day 337)

    Time to first hospitalisation for COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment). Time is days from start of study treatment to onset of exacerbation

  7. Number of Hospitalisations for COPD Exacerbations Per Patient - Exposure Adjusted

    Time frame: During actual study treatment period (planned Day 1 to Day 337)

    Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient adjusted by length of treatment exposure (i.e. no. of exacerbations multiplied by 365.25 and then divided by days of treatment exposure)

  8. Number of Hospitalisations for COPD Exacerbations Per Patient - naïve Estimate

    Time frame: During actual study treatment period (planned Day 1 to Day 337)

    Number of hospitalisations for COPD exacerbations (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment) per patient not adjusted for treatment exposure (i.e. naïve estimate)

  9. Number of Patients With at Least One Hospitalisation for a COPD Exacerbation

    Time frame: During actual study treatment period (planned Day 1 to Day 337)

    Number of patients with at least one hospitalisation for a COPD exacerbation (a complex of respiratory events/symptoms (increase or new onset) with a duration of 3 days or more requiring a change in treatment)

  10. Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 337

    Time frame: Baseline and Day 337

    The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

  11. Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Day 169

    Time frame: Baseline and Day 169

    The SGRQ total score measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

  12. Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 337

    Time frame: Baseline and Day 337

    The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

  13. Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Domain Score at Day 169

    Time frame: Baseline and Day 169

    The SGRQ domain score (symptom, activity and impact) measures quality of life on a continuous scale ranging from 0=best state to 100=worst state

  14. Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 29

    Time frame: Baseline and Day 29

    Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

  15. Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 169

    Time frame: Baseline and Day 169

    Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

  16. Change From Baseline in Trough Forced Vital Capacity (FVC) at Day 337

    Time frame: Baseline and Day 337

    Trough FVC is the mean maximum volume of air that can be forcibly expired from the lungs; measured approximately 24 hours after the last administration of study drug.

  17. Marked Changes From Baseline in Vital Signs at End of Treatment

    Time frame: Baseline and end of treatment

    Marked changes from baseline in vital signs (diastolic and systolic blood pressure (DBP and SBP) and pulse rate (PR)) at end of treatment.

    SBP - Increase means SBP >150 mmHg and an increase above baseline of >25 mmHg. SBP - Decrease means SBP <100 mmHg and a decrease below baseline of >10 mmHg.

    DBP - Increase means DBP >90 mmHg and an increase above baseline of >10 mmHg. DBP - Decrease means DBP <60 mmHg and a decrease below baseline of >10 mmHg.

    PR - Increase means PR >100 bpm and an increase above baseline of >10 bpm. PR - Decrease means PR <60 bpm and a decrease below baseline of >10 bpm.

  18. Clinically Relevant Findings in Physical Examination and ECG

    Time frame: End of treatment

    Clinically relevant findings in Physical Examination and ECG at end of treatment

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Efficacy {FEV1, COPD Exacerbations & HRQoL} & Safety of 5mcg Tiotropium Respimat in COPD

Important dates

Study start
2006
Primary completion
2009
First posted
Oct 12, 2006
Registry last updated
May 16, 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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