Completed

A Randomized, Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg Bid, 2.0mg Bid and Pulmicort Turbuhaler at 4.00mcg Bid on Adolescents (12 Yrs of Age and Older) With Adults With Moderate to Severe Asthma.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Budesonide

Drug
Who is being recruted

Asthma+6

+ Bronchial Diseases

+ Hypersensitivity

Over 12 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: April 2003
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleA Randomized, Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg Bid, 2.0mg Bid and Pulmicort Turbuhaler at 4.00mcg Bid on Adolescents (12 Yrs of Age and Older) With Adults With Moderate to Severe Asthma.
NCT00642122
Principal SponsorAstraZeneca
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

900 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AsthmaBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract Diseases

Criteria

3 inclusion criteria required to participate
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
3 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Pulmicort RESPULES

Group II

Experimental
Pulmicort TURBUHALER

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers
A Randomized, Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg Bid, 2.0mg Bid and Pulmicort Turbuhaler at 4.00mcg Bid on Adolescents (12 Yrs of Age and Older) With Adults With Moderate to Severe Asthma. | PatLynk