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Clinical Trials/NCT00144339
NCT00144339CompletedPhase 3

A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Boehringer Ingelheim585 sites in 1 country5,993 target enrollmentStarted: December 2002Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
5,993
Locations
585
Primary Endpoint
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.

Study Design

Study Type
Interventional
Intervention Model
Parallel
Primary Purpose
Treatment

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Written informed consent.
  • •Male or female patients 40 years of age or older.
  • •Smoking history of at least 10 pack years.
  • •Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1<70% of FVC and on stable respiratory medication.

Exclusion Criteria

  • •Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.
  • •Myocardial infarction in past 6 months.
  • •Unstable or life threatening arrhythmia in past year.
  • •Hospitalization for NYHA heart failure class III or IV in past year.
  • •Active tuberculosis.
  • •Pulmonary resection.
  • •Malignancy treated with radiation or chemotherapy in past 5 years.
  • •Respiratory infection in 4 weeks prior to screening.
  • •Known hypersensitivity to anticholinergic drugs or components.
  • •Known moderate to severe renal impairment.
  • •Known narrow angle glaucoma.
  • •Significant symptomatic BPH or bladder neck obstruction.
  • •Need for oxygen therapy >12 hr/day.
  • •Use of oral corticosteroids at unstable doses or >10 mg/day.

Outcomes

Primary Outcomes

Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years

Time Frame: From day 30 to 4 years

Rate of decline of forced expiratory volume in one second (FEV1) measured before the use of bronchodilators. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.

Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 30 to 4 Years

Time Frame: From day 30 to 4 years

Rate of decline of forced expiratory volume in one second (FEV1) measured after bronchodilation. A negative rate of decline indicates decreasing FEV1 over time, while a positive value indicates increasing FEV1.

Secondary Outcomes

  • Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment(Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.)
  • Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years(From day 30 to 4 years)
  • Time to First Exacerbation(From Day 1 to 4 years)
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 12(Month 12)
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 18(Month 18)
  • Number of Exacerbation Days Per Patient Year(Day 1 to 4 years)
  • Time to First COPD Exacerbation Leading to Hospitalization (for 25% Patients)(Day 1 to 4 years)
  • Number and Percentage of Patients With at Least on COPD Exacerbation Leading to Hospitalization(From Day 1 to 4 years)
  • Number of Exacerbation Leading to Hospitalization(From Day 1 to 4 years)
  • Rate of Decline of St George's Respiratory Questionnaire (SGRQ) Total Score(From month 6 to 4 years)
  • Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment(Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days)
  • Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 30 to 4 Years(From day 30 to 4 years)
  • Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years(From day 30 to 4 years)
  • Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 30 to 4 Years(From day 30 to 4 years)
  • Number and Percentage of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation(Day 1 to 4 years)
  • Pre-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment(Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days.)
  • Post-bronchodilator Forced Vital Capacity (FVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment(Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days)
  • Pre-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment(Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days)
  • Post-bronchodilator Slow Vital Capacity (SVC) Rate of Decline From Day 1 to 30 Days After Completion of Double Blinded Treatment(Day 1 to 30 days after completion of double blinded treatment between Day 1 and 4 years plus 30 days)
  • Number of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Patient Year(Day 1 to 4 years)
  • Days of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Leading to Hospitalization(From Day 1 to 4 years)
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1(Month 1)
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 1(Month 1)
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6(Month 6)
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 6(Month 6)
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12(Month 12)
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 12(Month 12)
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18(Month 18)
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 18(Month 18)
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24(Month 24)
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 24(Month 24)
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30(Month 30)
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 30(Month 30)
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36(Month 36)
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 36(Month 36)
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42(Month 42)
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 42(Month 42)
  • Estimated Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48(Month 48)
  • Estimated Post-bronchodilator Forced Expiratory Volume in One Second (FEV1) at Month 48(Month 48)
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 1(Month 1)
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 1(Month 1)
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 6(Month 6)
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 6(Month 6)
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 12(Month 12)
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 18(Month 18)
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 24(Month 24)
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 24(Month 24)
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 30(Month 30)
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 30(Month 30)
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 36(Month 36)
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 36(Month 36)
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 42(Month 42)
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 42(Month 42)
  • Estimated Pre-bronchodilator Forced Vital Capacity (FVC) at Month 48(Month 48)
  • Estimated Post-bronchodilator Forced Vital Capacity (FVC) at Month 48(Month 48)
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 1(Month 1)
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 6(Month 6)
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 30(Month 30)
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 36(Month 36)
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 12(Month 12)
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 1(Month 1)
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 24(Month 24)
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 24(Month 24)
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 18(Month 18)
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 18(Month 18)
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 6(Month 6)
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 12(Month 12)
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 12(Month 12)
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 30(Month 30)
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 36(Month 36)
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 42(Month 42)
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 42(Month 42)
  • Estimated Pre-bronchodilator Slow Vital Capacity (SVC) at Month 48(Month 48)
  • Estimated Post-bronchodilator Slow Vital Capacity (SVC) at Month 48(Month 48)
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 6(Month 6)
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 18(Month 18)
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 24(Month 24)
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 30(Month 30)
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 36(Month 36)
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 42(Month 42)
  • Estimated St George's Respiratory Questionnaire (SGRQ) Total Score at Month 48(Month 48)
  • Number and Percentage of Participants With All Cause Death and Time to Event Analysis (On-treatment)(Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days)
  • Number and Percentage of Participants With All Cause Death (Including Vital Status Follow-up, Cutoff at 1470 Days)(Day 1 to day 1470)
  • Number and Percentage of Participants With Lower Respiratory Death (On-treatment; Adjudicated Primary Cause)(Day 1 to completion of double blinded treatment plus 30 days between Day 1 and 4 years plus 30 days)
  • Number and Percentage of Participants With a Lower Respiratory Death (Adjudicated; Including Vital Status Follow-up, Cutoff at 1470 Days)(Day 1 to day 1470)

Investigators

Sponsor Class
Industry

Study Sites (585)

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