Status:
COMPLETED
Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be a...
Eligibility Criteria
Inclusion
- Main
- History of bronchial asthma
- FEV1 \> 1.20 L
- Positive Skin Prick Test
- Not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit
- Main
Exclusion
- Clinically relevant abnormal laboratory values
- Concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids
- Chronic obstructive pulmonary disease (COPD) and /or other relevant lung diseases
- One asthma exacerbation within 2 months or more than 3 exacerbations within the last year prior to baseline visit
- Current smokers or ex-smokers with more than 10 pack years, or having smoked within 1 year prior to baseline visit
- Positive response to saline challenge at baseline visits
- Positive bronchial hyperresponsiveness
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00306163
Start Date
May 1 2006
End Date
September 1 2008
Last Update
February 1 2017
Active Locations (1)
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1
Altana Pharma/Nycomed
RB Groningen, Netherlands, 9700