Status:
COMPLETED
An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00365560
Start Date
August 1 2006
Last Update
July 11 2013
Active Locations (16)
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1
Boehringer Ingelheim Investigational Site
Aalborg, Denmark
2
Boehringer Ingelheim Investigational Site
Aarhus C, Denmark
3
Boehringer Ingelheim Investigational Site
Hvidovre, Denmark
4
Boehringer Ingelheim Investigational Site
K?benhavn NV, Denmark