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

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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:

PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume) [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
Provocative concentration of methacholine is that causing a 20% fall in FEV1. The methacholine challenge test entailed the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 had been reduced by 20%.

The ratio of Methacholine concentration measured at 2 weeks to that at Baseline.

Secondary Outcome Measures:

Peak Exploratory Flow (PEF) [ Time Frame: Baseline to week 2 recorded daily ] [ Designated as safety issue: No ]
Change in PEF at Week 2 from baseline, mean over all days in run-in and all dasy in treatment period, with baseline as covariate.
FEV1 (Forced Expiratory Volume in 1 Second) [ Time Frame: Baseline to week 2 ] [ Designated as safety issue: No ]
FEV1 change from baseline
FEF 25-75 (Forced Expiratory Flow 25-75) [ Time Frame: Baseline and week 2 ] [ Designated as safety issue: No ]
FEF 25-75- Forced expiratory flow over the middle one half of the FVC. The results are expressed as the change from baseline
eNO (Exhaled Nitrogen Oxide) [ Time Frame: baseline and week 2 ] [ Designated as safety issue: No ]
eNO ratio of baseline
Asthma Symptom Score Morning [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Asthma Symptom score recorded daily in the morning: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the morning is presented.
Asthma Symptom Score Evening [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Asthma Symptom score recorded daily in the evening: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the evening is presented.
Asthma Symptom Score Total [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Asthma Symptom score recoded daily, Total. Scale: 0 - 3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily is presented.
Rescue Medication Morning [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
The average of means for inhalations of rescue medication in the morning is presented.
Rescue Medication Evening [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
The average of means for inhalations of rescue medication in the evening is presented.
Rescue Medication Total [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
The average of means for inhalations of rescue medication in morning and evening combined over a 24 hour period is presented.
Peak Exploratory Flow (PEF) Morning [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Peak Exploratory Flow (PEF) recorded daily in the morning

Enrollment:	99
Study Start Date:	April 2008
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Budesonide Hydrofluoroalkane (HFA) 100 Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks	Drug: Budesonide HFA standard daily inhaled dose
Active Comparator: Budesonide HFA 400 Budesonide HFA 400 mcg twice daily for 2 weeks	Drug: Budesonide HFA standard daily inhaled dose
Active Comparator: Budesonide Chlorofluorocarbon (CFC) 100 Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks	Drug: Budesonide CFC standard daily inhaled dose
Active Comparator: Budesonide CFC 400 Budesonide CFC 400 mcg twice daily for 2 weeks	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
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
ClinicalTrials.gov Identifier:	NCT00667992 History of Changes
Other Study ID Numbers:	D5252C00008
Study First Received:	April 23, 2008
Results First Received:	May 12, 2010
Last Updated:	October 9, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Asthma hyperreactivity

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013