Inhaled Steroid Treatment as Regular Therapy in Early Asthma
- Registration Number
- NCT00641914
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6800
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 budesonide - 2 Placebo -
- Primary Outcome Measures
Name Time Method Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B) At week 6 and12, and every 3 months thereafter
- Secondary Outcome Measures
Name Time Method Pre-bronchodilator FEV1 % of predicted normal At week 6 and12, and every 3 months thereafter HE: Asthma related events and health care utilisation, and symptom free days (SFD) At week 6 and12, and every 3 months thereafter Post-bronchodilator FVC % of predicted At week 6 and12, and every 3 months thereafter