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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00667992 |
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.
Condition | Intervention | Phase |
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Asthma |
Drug: Budesonide HFA Drug: Budesonide CFC |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Bud HFA
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Drug: Budesonide HFA
standard daily inhaled dose
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2: Active Comparator
Bud CFC
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Drug: Budesonide CFC
standard daily inhaled dose
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Research Site | |
King of Prussia, Pennsylvania, United States | |
United Kingdom, Scotland | |
Research Site | |
Dundee, Scotland, United Kingdom | |
Research Site | |
Perth, Scotland, United Kingdom |
Principal Investigator: | Brian Lipworth, PhD, MD | Asthma and Allergy Research Group Division of Medicine and Therapeutics Ninewells Hospital and Medical School University of Dundee |
Responsible Party: | AstraZeneca Pharmaceuticals ( Lars-Göran Carlsson, MD, Medical Science Director, RITA Established Brands Project Team ) |
Study ID Numbers: | D5252C00008 |
Study First Received: | April 23, 2008 |
Last Updated: | April 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00667992 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Asthma hyperreactivity |
Anti-Inflammatory Agents Bronchial Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Asthma Hormones Glucocorticoids Lung Diseases, Obstructive |
Hypersensitivity Respiratory Tract Diseases Lung Diseases Methacholine Chloride Hypersensitivity, Immediate Hyperkinesis Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Budesonide Anti-Asthmatic Agents Asthma Hormones Glucocorticoids |
Pharmacologic Actions Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |