Adults With Moderate to Severe Asthma - Tabular View

Tracking Information

First Received Date ^ICMJE

March 18, 2008

Last Updated Date

March 24, 2009

Start Date ^ICMJE

April 2003

Primary Completion Date

December 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00642122 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Adults With Moderate to Severe Asthma

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Budesonide

Study Arms / Comparison Groups

Experimental: Pulmicort RESPULES
Experimental: Pulmicort TURBUHALER

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

900

Completion Date

December 2004

Primary Completion Date

December 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00642122

Responsible Party

Lars-Göran Carlsson

Study ID Numbers ^ICMJE

SD-004-0764, D5257L00012

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bertil Andersson

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP