Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma
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ClinicalTrials.gov Identifier: NCT00667992 |
Recruitment Status :
Completed
First Posted : April 28, 2008
Results First Posted : November 7, 2012
Last Update Posted : November 7, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: Budesonide HFA Drug: Budesonide CFC | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 99 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (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 |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | May 2009 |

Arm | Intervention/treatment |
---|---|
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 |
- PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume) [ Time Frame: Baseline and week 2 ]
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.
- Peak Exploratory Flow (PEF) [ Time Frame: Baseline to week 2 recorded daily ]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 ]FEV1 change from baseline
- FEF 25-75 (Forced Expiratory Flow 25-75) [ Time Frame: Baseline and week 2 ]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 ]eNO ratio of baseline
- Asthma Symptom Score Morning [ Time Frame: 2 weeks ]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 ]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 ]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 ]The average of means for inhalations of rescue medication in the morning is presented.
- Rescue Medication Evening [ Time Frame: 2 weeks ]The average of means for inhalations of rescue medication in the evening is presented.
- Rescue Medication Total [ Time Frame: 2 weeks ]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 ]Peak Exploratory Flow (PEF) recorded daily in the morning

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667992
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 |
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 |
ClinicalTrials.gov Identifier: | NCT00667992 |
Other Study ID Numbers: |
D5252C00008 |
First Posted: | April 28, 2008 Key Record Dates |
Results First Posted: | November 7, 2012 |
Last Update Posted: | November 7, 2012 |
Last Verified: | October 2012 |
Asthma hyperreactivity |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide |
Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |