Inhaled Steroid Treatment as Regular Therapy in Early 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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- 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
Outcome Measures for this Clinical Trial
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
- 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
- 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
- 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
- Time Frame: At week 6 and12, and every 3 months thereafter
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Romain Pauwels Study Chair Steering Committee Chairman
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00641914
