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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00667992

Purpose

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
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 [ Time Frame: The methacholine challenge test will entail the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 has been reduced by 20%. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from pooled baseline in PEF, FEV1 and Forced Expiratory Flow (FEF25-75) for each treatment [ Time Frame: PEF, FEV1 and Forced Expiratory Flow (FEF25-75) will be measured at each visit from Visit 2 to Visit 7. ] [ Designated as safety issue: No ]
Change from pooled baseline in exhaled NO for each treatment [ Time Frame: Tidal exhaled nitric oxide (eNO) will be measured at each visit from Visit 2 to Visit 7. ] [ Designated as safety issue: No ]
Asthma symptom scores (day, night and total) and rescue use consumption (day, night and total) for each treatment. [ Time Frame: Subjects will be asked to record information twice daily onto a paper diary card (Visit 1-7). ] [ Designated as safety issue: No ]
Change in pooled baseline for morning PEF [ Time Frame: From daily diary ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2008
Study Completion Date:	May 2009

Arms	Assigned Interventions
1: Active Comparator Bud HFA	Drug: Budesonide HFA standard daily inhaled dose
2: Active Comparator Bud CFC	Drug: Budesonide CFC standard daily inhaled dose

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667992

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Brian Lipworth, PhD, MD

Asthma and Allergy Research Group Division of Medicine and Therapeutics Ninewells Hospital and Medical School University of Dundee

More Information

No publications provided

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:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00667992 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Asthma hyperreactivity

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on November 25, 2009