Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)
Phase 3
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Registration Number
- NCT00281567
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
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
- Tuberculosis
- Pulmonary resection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Boehringer Ingelheim Investigational Site
🇳🇱Study chairs or principal investigators, Netherlands