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Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium | Drug | |||
| Respimat SMI | Device | |||
| HandiHaler | Device |
| Measure | Description | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim KG | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Study Chairs Or Principal Investigators | Belgium | ||||
| Boehringer Ingelheim Investigational Site |
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| 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 |
| Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients | up to 28 weeks |
| 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 |
| Study Chairs Or Principal Investigators |
| Netherlands |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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