Official Title: “A Randomized, Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg Bid, 2.0mg Bid and Pulmicort Turbuhaler at 4.00mcg Bid on Adolescents (12 Yrs of Age and Older) With Adults With Moderate to Severe Asthma.”

A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.

Study Type: Interventional

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

Study Primary Completion Date: December 2004

Intervention(s) in this Clinical Trial

• Drug: Budesonide
  • 0.5mg once daily
• Drug: Budesonide
  • 1mg once daily
• Drug: Budesonide
  • 1mg twice daily
• Drug: Budesonide
  • 2mg once daily
• Drug: Budesonide
  • 4.00mcg twice daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Pulmicort RESPULES
• Experimental: 2
  • Pulmicort TURBUHALER

Primary Measures

• Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg.
  • Time Frame: Day -14, 1, and every 28 days thereafter
    

Secondary Measures

• Percentage of symptom free days
  • Time Frame: Day -14, 1, and every 28 days thereafter
    
• Percentage of symptom free nights
  • Time Frame: Day -14, 1, and every 28 days thereafter
    
• Percentage of symptom free 24-hours
  • Time Frame: Day -14, 1, and every 28 days thereafter
    

Inclusion Criteria:

• Male or female aged 12 or over who have asthma
• Ability to properly use an electronic diary
• Able and willing to nebulize for up to 20 minutes every morning and evening

Exclusion Criteria:

• Hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months
• Planned hospitalisation during the study
• pregnant women or women planning to become pregnant

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 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 AstraZeneca  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00642122

Study ID Number: SD-004-0764

ClinicalTrials.gov Identifier: NCT00642122

Health Authority: United States: Food and Drug Administration