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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667992
• Other study ID #: D5252C00008
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2008
• Last updated: October 9, 2012
• Start date: April 2008
• Est. completion date: May 2009

Study information

• Verified date: October 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide HFA
standard daily inhaled dose
• Budesonide CFC
standard daily inhaled dose

Locations

Country	Name	City	State
United Kingdom	Research Site	Dundee	Scotland
United Kingdom	Research Site	Perth	Scotland
United States	Research Site	King of Prussia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	FEV1 (Forced Expiratory Volume in 1 Second)	FEV1 change from baseline	Baseline to week 2	No
Secondary	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	No
Secondary	eNO (Exhaled Nitrogen Oxide)	eNO ratio of baseline	baseline and week 2	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Rescue Medication Morning	The average of means for inhalations of rescue medication in the morning is presented.	2 weeks	No
Secondary	Rescue Medication Evening	The average of means for inhalations of rescue medication in the evening is presented.	2 weeks	No
Secondary	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	No
Secondary	Peak Exploratory Flow (PEF) Morning	Peak Exploratory Flow (PEF) recorded daily in the morning	2 weeks	No