Inhaled Steroid Treatment as Regular Therapy in Early Asthma

Condition(s) targeted: Asthma

Intervention: budesonide (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Romain Pauwels, Study Chair, Affiliation: Steering Committee Chairman
William Busse, Study Chair, Affiliation: Steering Committee Chairman

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.

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.

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

Primary outcome: Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B)

Secondary outcome:

Pre-bronchodilator FEV1 % of predicted normal

HE: Asthma related events and health care utilisation, and symptom free days (SFD)

Post-bronchodilator FVC % of predicted

Minimum age: 6 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Starting date: October 1996
Ending date: April 2003
Last updated: March 21, 2008