EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks

Budesonide HFA 400 mcg twice daily for 2 weeks

Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks

Budesonide CFC 400 mcg twice daily for 2 weeks

CSR-D5252C00008-final.pdf

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 comparing budesonide hydrofluoroalkane (HFA) vs chlorofluorocarbon (CFC) pressurized metered dose inhalers (pMDI) in patients with mild to moderate asthma

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EudraCT Number

NCT ID

Patient Level Data

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Research Site

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

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.

Age Continuous

Gender, Male/Female

Full analysis set (FAS).
The FAS was defined as all randomised patients who contributed data from at least one period
(ie data from both low and high dose of one inhaler).

PC 20 methacholine (Provocative concentration of methacholine causing 20 % fall in  FEV1(Forced Expiratory Volume)

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.

Peak Exploratory Flow (PEF)

FEV1 (Forced Expiratory  Volume in 1 second)

FEF 25-75- Forced expiratory flow over the middle one half of the FVC. The results are expressed as the change from baseline

FEF 25-75 (Forced Expiratory Flow 25-75)

eNO (exhaled Nitrogen Oxide)

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 morning

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 evening

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.

Asthma Symptom score Total

The average of means for inhalations of rescue medication in the morning is presented.

Rescue medication morning

The average of means for inhalations of rescue medication in the evening is presented.

Rescue medication evening

The average of means for inhalations of rescue medication in morning and evening combined over a 24 hour period is presented.

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

study comparing budesonide hydrofluoroalkane (HFA) vs chlorofluorocarbon (CFC) pressurized metered dose inhalers (pMDI) in patients with mild to moderate asthma

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

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Study type

Age

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Study design

Verification:

Sponsors

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Inclusion Criteria

Documents available

CSR Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator