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

Condition(s) targeted: Asthma

Intervention: Budesonide HFA (Drug); Budesonide CFC (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Brian Lipworth, PhD, MD, Principal Investigator, Affiliation: Asthma and Allergy Research Group Division of Medicine and Therapeutics Ninewells Hospital and Medical School University of Dundee

Overall contact:
Mira DeMaeyer Omnicare Clinical Research, Phone: +32 2 247 94 83, Email: Mira.DeMaeyer@omnicarecr.com

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: 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

Study design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Primary outcome: Change from pooled baseline (i.e., post run-in or washout periods) in methacholine airway responsiveness measured as the provocative concentration of methacholine (PC20) that causes a 20% drop in FEV1 for each treatment

Secondary outcome:

Change from pooled baseline in PEF, FEV1 and Forced Expiratory Flow (FEF25-75) for each treatment

Change from pooled baseline in exhaled NO for each treatment

Asthma symptom scores (day, night and total) and rescue use consumption (day, night and total) for each treatment.

Change in pooled baseline for morning PEF

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Mira DeMaeyer Omnicare Clinical Research, Phone: +32 2 247 94 83, Email: Mira.DeMaeyer@omnicarecr.com

Research Site, King of Prussia, Pennsylvania, United States; Recruiting

Research Site, Dundee, Scotland, United Kingdom; Recruiting

Research Site, Perth, Scotland, United Kingdom; Recruiting

Starting date: April 2008
Ending date: March 2009
Last updated: October 3, 2008