Status:
COMPLETED
Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study is being carried out to see if budesonide with HFA is effective, safe and well tolerated compared with budesonide CFC. Budesonide HFA has been already given in other research studies, in bo...
Eligibility Criteria
Inclusion
- Patients suffering from stable, persistent, mild to moderate asthma as defined by Global Initiative for Asthma (GINA) Guidelines and for whom FEV1 \> 60 %
- ICS taking ≤ 1000 μg BDP per day, or equivalent
- Methacholine PC20 \< 4 mg/mL
Exclusion
- Known or suspected hypersensitivity to budesonide or any other constituents of the budesonide HFA pMDI or budesonide CFC pMDI.
- Currently a smoker or who has ceased smoking within 6 months of Visit 1.
- Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or bronchiectasis
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00667992
Start Date
April 1 2008
End Date
May 1 2009
Last Update
November 7 2012
Active Locations (3)
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1
Research Site
King of Prussia, Pennsylvania, United States
2
Research Site
Dundee, Scotland, United Kingdom
3
Research Site
Perth, Scotland, United Kingdom