Official Title: “A Placebo-Controlled Comparison of the Efficacy and Safety of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Adults Currently Treated With Inhaled Steroids.”

A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in adult patients who have asthma and are currently being treated with inhaled steroids. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2004

Intervention(s) in this Clinical Trial

• Drug: budesonide
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Pulmicort
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Change from Baseline in Forced Expiratory Volume in 1 second
  • Time Frame: Week 2, 4 and 8, then at week 12
    

Secondary Measures

• Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate.
  • Time Frame: Week 2, 4 and 8, then at week 12
    
• Incidence of Adverse Events
  • Time Frame: Week 2,4 and 8, then at week 12
    
• Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration)
  • Time Frame: 6 or 12 hours post dose
    

Inclusion Criteria:

• Males and females at least 18 years old with a diagnosis of asthma (as defined by the ATS) for at least 6 months.
• To enter the run in period, subjects were also required to have the following:
• A forced expiratory volume (FEV1) in 1 second of 60% to 90% of predicted normal, airway reversibility of at least 12% and 0.20 L, use of orally inhaled corticosteroids for at least 3 months prior to the study.
• At Visit 2, subjects who met additional entry criteria related to rescue medication use and asthma symptom scores during the run in period plus visit specific FEV1 requirements were assigned to randomized treatments

Exclusion Criteria:

• Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
• Use of steroid tablets or injections during the month (28 days) prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
• Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to the study. Subject must not smoke or have smoked within 6 months of the study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Bertil Andersson Study Director AZ employee  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642187

Study ID Number: SD-004-0620

ClinicalTrials.gov Identifier: NCT00642187

Health Authority: United States: Food and Drug Administration