Official Title: “Inhaled Steroid Treatment As Regular Therapy in Early Asthma. A Study on the Effect of Early Intervention With Long-Term Inhaled Budesonide (Pulmicort Turbuhaler ® ) in Newly Diagnosed Asthma.”

A study of the effect of the early treatment with Pulmicort of newly diagnosed asthma.

Patients will receive either Pulmicort or a non-active treatment for three years. Neither patients or investigators will be aware of the treatment received. After three years of treatment all patients will receive Pulmicort for 2 further years.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Study Primary Completion Date: February 2003

Intervention(s) in this Clinical Trial

• Drug: budesonide
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B)
  • Time Frame: At week 6 and12, and every 3 months thereafter
    

Secondary Measures

• Pre-bronchodilator FEV1 % of predicted normal
  • Time Frame: At week 6 and12, and every 3 months thereafter
    
• HE: Asthma related events and health care utilisation, and symptom free days (SFD)
  • Time Frame: At week 6 and12, and every 3 months thereafter
    
• Post-bronchodilator FVC % of predicted
  • Time Frame: At week 6 and12, and every 3 months thereafter
    

Inclusion Criteria:

• Male or female patients aged between 6 and 60 years
• diagnosed with asthma within 2 years of starting the study
• Ability to use a Turbuhaler

Exclusion Criteria:

• Symptoms indicating asthma (e.g. wheezing) for more than two years prior to starting the study
• A history of the use of treatments like Pulmicort for more than 30 days per year in the two years before starting the study
• Regular daily treatment for asthma for more than two years before starting the study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Romain Pauwels Study Chair Steering Committee Chairman  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00641914

Study ID Number: SD-004-0111

ClinicalTrials.gov Identifier: NCT00641914

Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica