Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma

Completed · Phase 3

Conditions studied: Asthma

In brief

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 both healthy volunteers and subjects with asthma.

Key facts

Study ID

NCT00667992

Run by

AstraZeneca

People needed

99

Starts

2008-04-01

Expected to finish

2009-05-01

Last updated by the study team

2012-11-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — King of Prussia, Pennsylvania, United States
• Research Site — Dundee, Scotland, United Kingdom
• Research Site — Perth, Scotland, United Kingdom

Full record on ClinicalTrials.gov

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