A Randomised, Double-blind, Double-dummy, Placebo-controlled, Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim1 site in 1 country76 target enrollmentAugust 2002

ConditionsPulmonary Disease, Chronic Obstructive

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Enrollment: 76
Locations: 1
Primary Endpoint: Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.

Registry

clinicaltrials.gov

Start Date

August 2002

End Date

July 2003

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

Inclusion Criteria

•Diagnosis of COPD
•FEV1 \< 60% predicted
•FEV1 \< 70% of FVC
•Smoking history of 10 pack-years

Exclusion Criteria

•Significant other disease than COPD
•Recent history of MI (1 year or less)
•Cardiac arrhythmia requiring drug therapy
•History of asthma, allergic rhinitis or eosinophil count \> 600 mm3
•Symptomatic prostatic hypertrophy or bladder neck obstruction
•Known narrow-angle glaucoma
•Abnormal baseline hematology, blood chemistry or urinalysis
•History of cancer within last 5 years
•Life-threatening pulmonary obstruction
•Cystic fibrosis or bronchiectasis

Outcomes

Primary Outcomes

Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).

Secondary Outcomes

Individual FEV1and FVC measurements at each time point(up to 28 weeks)
Trough forced vital capacity (FVC) response after 4 weeks (change from baseline)(baseline until week 28)
Peak response (FEV1 and FVC) to first dose(within 3 hours to first dose)
Peak response (FEV1 and FVC) after 4 weeks(within 3 hours after 4 weeks)
Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients(up to 28 weeks)
FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks(after 4 weeks)
Number of patients with 15% response above baseline for each treatment at each timepoint after first dose(at week 4, 12, 20)
FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks(after first dose and after 4 weeks)
Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks(at week 8, 16, 24)
Number of occasions of rescue therapy used as required (p.r.n. salbutamol)(up to 28 weeks)
Median time to onset of therapeutic response after first dose(after 4 weeks)