An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma
Phase 2
Completed
- Conditions
- Asthma
- Registration Number
- NCT00365560
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
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
- with a recent history (i.e., six months or less) of myocardial infarction,
- who have been hospitalized for heart failure (NYHA class III or IV) within the past year,
- with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year,
- with malignancy for which the patient has undergone resection, radiation ther apy or chemotherapy within the last five years,
- who have undergone thoracotomy with pulmonary resection,
- with moderate to severe renal impairment (creatinine clearance = 50 mL/min)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint is the FEV1 response (within 3 hours post dosing) determined at the end of the 8-week treatment period
- Secondary Outcome Measures
Name Time Method FEV1 and FVC AUC 0-3h (in a subset 0-24h) PEF, use of rescue medication, daytime and nocturnal symptoms etc.
Trial Locations
- Locations (5)
lokatie het Spittaal
🇳🇱Zutphen, Netherlands
Polikliniek longziekten
🇳🇱Hengelo, Netherlands
Boehringer Ingelheim Investigational Site
🇩🇪Wiesloch, Germany
lokatie Langendijk
🇳🇱Breda, Netherlands
Polikliniek Longziekten
🇳🇱Heerlen, Netherlands