Inhaled Steroid Treatment as Regular Therapy in Early Asthma

Phase 4CompletedNCT00641914

AstraZeneca6,800 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

6,800

Conditions

Asthma

Interventions

budesonideDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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