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The primary objective of this study is to examine efficacy and safety of tiotropium compared to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tiotropium | Drug | |||
| placebo | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the FEV1 response (within 3 hours post dosing) determined at the end of the 8-week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 and FVC AUC 0-3h (in a subset 0-24h) PEF, use of rescue medication, daytime and nocturnal symptoms etc. |
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Inclusion Criteria:
Outpatients of either sex, age 18 - 75 years, with at least a documented 5 year history of asthma, and a current diagnosis of severe, persistent asthma (GINA step 4), smoking history < 10 pack years and >= 1 year smoking cessation; Patients must be symptomatic
Exclusion Criteria:
Patients
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Aalborg | Denmark | ||||
| Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21636120 | Derived | Kerstjens HA, Disse B, Schroder-Babo W, Bantje TA, Gahlemann M, Sigmund R, Engel M, van Noord JA. Tiotropium improves lung function in patients with severe uncontrolled asthma: a randomized controlled trial. J Allergy Clin Immunol. 2011 Aug;128(2):308-14. doi: 10.1016/j.jaci.2011.04.039. Epub 2011 Jun 2. |
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| Aarhus C |
| Denmark |
| Boehringer Ingelheim Investigational Site | Hvidovre | Denmark |
| Boehringer Ingelheim Investigational Site | K?benhavn NV | Denmark |
| Boehringer Ingelheim Investigational Site | Odense C | Denmark |
| Boehringer Ingelheim Investigational Site | Gelnhausen | Germany |
| Boehringer Ingelheim Investigational Site | Gro?hansdorf | Germany |
| Boehringer Ingelheim Investigational Site | Rüdersdorf | Germany |
| Boehringer Ingelheim Investigational Site | Wiesbaden | Germany |
| Boehringer Ingelheim Investigational Site | Wiesloch | Germany |
| lokatie Langendijk | Breda | Netherlands |
| Polikliniek longziekten | Eindhoven | Netherlands |
| Polikliniek longziekten | Groningen | Netherlands |
| Polikliniek Longziekten | Heerlen | Netherlands |
| Polikliniek longziekten | Hengelo | Netherlands |
| lokatie het Spittaal | Zutphen | Netherlands |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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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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