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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide HFA
* Drug: Budesonide CFC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Budesonide Hydrofluoroalkane (HFA) 100<br>Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks | Drug: Budesonide HFA<br>* standard daily inhaled dose<br>|
| Active Comparator: Budesonide HFA 400<br>Budesonide HFA 400 mcg twice daily for 2 weeks | Drug: Budesonide HFA<br>* standard daily inhaled dose<br>|
| Active Comparator: Budesonide Chlorofluorocarbon (CFC) 100<br>Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks | Drug: Budesonide CFC<br>* standard daily inhaled dose<br>|
| Active Comparator: Budesonide CFC 400<br>Budesonide CFC 400 mcg twice daily for 2 weeks | Drug: Budesonide CFC<br>* standard daily inhaled dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume) | 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. | Baseline and week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Exploratory Flow (PEF) | 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. | Baseline to week 2 recorded daily | 
| FEV1 (Forced Expiratory Volume in 1 Second) | FEV1 change from baseline | Baseline to week 2 | 
| FEF 25-75 (Forced Expiratory Flow 25-75) | FEF 25-75- Forced expiratory flow over the middle one half of the FVC. The results are expressed as the change from baseline | Baseline and week 2 | 
| eNO (Exhaled Nitrogen Oxide) | eNO ratio of baseline | baseline and week 2 | 
| Asthma Symptom Score Morning | 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. | 2 weeks | 
| Asthma Symptom Score Evening | 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. | 2 weeks | 
| Asthma Symptom Score Total | 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. | 2 weeks | 
| Rescue Medication Morning | The average of means for inhalations of rescue medication in the morning is presented. | 2 weeks | 
| Rescue Medication Evening | The average of means for inhalations of rescue medication in the evening is presented. | 2 weeks | 
| Rescue Medication Total | The average of means for inhalations of rescue medication in morning and evening combined over a 24 hour period is presented. | 2 weeks | 
| Peak Exploratory Flow (PEF) Morning | Peak Exploratory Flow (PEF) recorded daily in the morning | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma hyperreactivity