Adults With Moderate to Severe 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

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-12-31

Brief Summary

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A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.

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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

SINGLE

Study Groups

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1

Pulmicort RESPULES

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

0.5mg once daily

Budesonide

Intervention Type DRUG

1mg once daily

Budesonide

Intervention Type DRUG

1mg twice daily

Budesonide

Intervention Type DRUG

2mg once daily

2

Pulmicort TURBUHALER

Group Type EXPERIMENTAL

Budesonide

Intervention Type DRUG

4.00mcg twice daily

Interventions

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Budesonide

0.5mg once daily

Intervention Type DRUG

Budesonide

1mg once daily

Intervention Type DRUG

Budesonide

1mg twice daily

Intervention Type DRUG

Budesonide

2mg once daily

Intervention Type DRUG

Budesonide

4.00mcg twice daily

Intervention Type DRUG

Other Intervention Names

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Pulmicort RESPULES Pulmicort RESPULES Pulmicort RESPULES Pulmicort RESPULES Pulmicort TURBUHALER

Eligibility Criteria

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Inclusion Criteria

* Male or female aged 12 or over who have asthma
* Ability to properly use an electronic diary
* Able and willing to nebulize for up to 20 minutes every morning and evening

Exclusion Criteria

* Hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months
* Planned hospitalisation during the study
* pregnant women or women planning to become pregnant

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No