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”

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

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

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Bud HFA
• Active Comparator: 2
  • Bud CFC

Primary Measures

• 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
  • Time Frame: The methacholine challenge test will entail the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 has been reduced by 20%.
    Safety Issue?: No

Secondary Measures

• Change from pooled baseline in PEF, FEV1 and Forced Expiratory Flow (FEF25-75) for each treatment
  • Time Frame: PEF, FEV1 and Forced Expiratory Flow (FEF25-75) will be measured at each visit from Visit 2 to Visit 7.
    Safety Issue?: No
• Change from pooled baseline in exhaled NO for each treatment
  • Time Frame: Tidal exhaled nitric oxide (eNO) will be measured at each visit from Visit 2 to Visit 7.
    Safety Issue?: No
• Asthma symptom scores (day, night and total) and rescue use consumption (day, night and total) for each treatment.
  • Time Frame: Subjects will be asked to record information twice daily onto a paper diary card (Visit 1-7).
    Safety Issue?: No
• Change in pooled baseline for morning PEF
  • Time Frame: From daily diary
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Brian Lipworth, PhD, MD Principal Investigator 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 +32 2 247 94 83 Mira.DeMaeyer@omnicarecr.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00667992

Study ID Number: D5252C00008

ClinicalTrials.gov Identifier: NCT00667992

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency