Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks | after 4 weeks |
| FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks | after first dose and after 4 weeks |
| 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 |
| 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 |
| Number of patients with 15% response above baseline for each treatment at each timepoint after first dose | at week 4, 12, 20 |
| Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks | at week 8, 16, 24 |
| Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients | up to 28 weeks |
Countries
Belgium, Netherlands
Outcome results
None listed