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

AstraZeneca99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

Budesonide HFADRUG

standard daily inhaled dose

Budesonide CFCDRUG

standard daily inhaled dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

Research Site

King of Prussia, Pennsylvania, United States

Research Site

Dundee, Scotland, United Kingdom

Research Site

Perth, Scotland, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Baseline and week 2

Secondary Outcomes

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.

Time frame: Baseline to week 2 recorded daily

FEV1 (Forced Expiratory Volume in 1 Second)

FEV1 change from baseline

Time frame: 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

Time frame: Baseline and week 2

eNO (Exhaled Nitrogen Oxide)

eNO ratio of baseline

Time frame: 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.

Data from ClinicalTrials.gov

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