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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Budesonide HFA; Drug: Budesonide CFC

• Registration Number: NCT00667992
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-27
• Study First Posted: 2008-04-28
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2010-05-12
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-09
• Last Update Submitted: 2012-10-09
• Results First Posted: 2012-11-07
• Last Update Posted: 2012-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Budesonide Hydrofluoroalkane (HFA) 100	Budesonide HFA	Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
Budesonide HFA 400	Budesonide HFA	Budesonide HFA 400 mcg twice daily for 2 weeks
Budesonide Chlorofluorocarbon (CFC) 100	Budesonide CFC	Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
Budesonide CFC 400	Budesonide CFC	Budesonide CFC 400 mcg twice daily for 2 weeks

Primary Outcome Measures

Name	Time	Method
PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume)	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.

Secondary Outcome Measures

Name	Time	Method
Peak Exploratory Flow (PEF)	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)	Baseline to week 2	FEV1 change from baseline
FEF 25-75 (Forced Expiratory Flow 25-75)	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)	baseline and week 2	eNO ratio of baseline
Asthma Symptom Score Morning	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	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	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	2 weeks	The average of means for inhalations of rescue medication in the morning is presented.
Rescue Medication Evening	2 weeks	The average of means for inhalations of rescue medication in the evening is presented.
Rescue Medication Total	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	2 weeks	Peak Exploratory Flow (PEF) recorded daily in the morning

Trial Locations

Locations (1)

Research Site; 🇬🇧 Perth, Scotland, United Kingdom