Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Budesonide HFA (Drug); Budesonide CFC (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Brian Lipworth, PhD, MD, Principal Investigator, Affiliation: Asthma and Allergy Research Group Division of Medicine and Therapeutics Ninewells Hospital and Medical School University of Dundee
Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
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 both healthy volunteers and subjects with asthma.
Clinical Details
Official title: A Phase 3, Randomised, Open-Label, Crossover Study to Compare HFA vs CFC pMDI Formulations of Budesonide on Methacholine Hyper-Reactivity in Patients With Stable, Persistent, Mild to Moderate Asthma
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Change from pooled baseline (i.e., post run-in or washout periods) in methacholine airway responsiveness measured as the provocative concentration of methacholine (PC20) that causes a 20% drop in FEV1 for each treatment
Secondary outcome: Change from pooled baseline in PEF, FEV1 and Forced Expiratory Flow (FEF25-75) for each treatmentChange from pooled baseline in exhaled NO for each treatment Asthma symptom scores (day, night and total) and rescue use consumption (day, night and total) for each treatment. Change in pooled baseline for morning PEF
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Research Site, King of Prussia, Pennsylvania, United States; Recruiting
Research Site, Dundee, Scotland, United Kingdom; Recruiting
Research Site, Perth, Scotland, United Kingdom; Recruiting
Additional Information
Starting date: April 2008
Ending date: March 2009
Last updated: November 11, 2008
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