Inhaled Steroid Treatment as Regular Therapy in Early Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

6800 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-10-31

Study Completion Date

2003-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Group Type EXPERIMENTAL

budesonide

Intervention Type DRUG

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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budesonide

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Pulmicort

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No