Adults With Moderate to Severe Asthma

January 21, 2011 updated by: AstraZeneca

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

900

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Pulmicort RESPULES
Drug: Budesonide
0.5mg once daily
Other Names:
  • Pulmicort RESPULES
Drug: Budesonide
1mg once daily
Other Names:
  • Pulmicort RESPULES
Drug: Budesonide
1mg twice daily
Other Names:
  • Pulmicort RESPULES
Drug: Budesonide
2mg once daily
Other Names:
  • Pulmicort RESPULES
Drug: Budesonide
4.00mcg twice daily
Other Names:
  • Pulmicort TURBUHALER
Experimental: 2
Pulmicort TURBUHALER
Drug: Budesonide
0.5mg once daily
Other Names:
  • Pulmicort RESPULES
Drug: Budesonide
1mg once daily
Other Names:
  • Pulmicort RESPULES
Drug: Budesonide
1mg twice daily
Other Names:
  • Pulmicort RESPULES
Drug: Budesonide
2mg once daily
Other Names:
  • Pulmicort RESPULES
Drug: Budesonide
4.00mcg twice daily
Other Names:
  • Pulmicort TURBUHALER

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg.
Time Frame: Day -14, 1, and every 28 days thereafter
Day -14, 1, and every 28 days thereafter

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of symptom free days
Time Frame: Day -14, 1, and every 28 days thereafter
Day -14, 1, and every 28 days thereafter
Percentage of symptom free nights
Time Frame: Day -14, 1, and every 28 days thereafter
Day -14, 1, and every 28 days thereafter
Percentage of symptom free 24-hours
Time Frame: Day -14, 1, and every 28 days thereafter
Day -14, 1, and every 28 days thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (Estimate)

March 24, 2008

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SD-004-0764
  • D5257L00012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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