Inhaled Steroid Treatment as Regular Therapy in Early Asthma - Tabular View

Tracking Information

First Received Date ^ICMJE

March 18, 2008

Last Updated Date

March 24, 2009

Start Date ^ICMJE

October 1996

Primary Completion Date

February 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Severe asthma related events (SARE) (part A); post-bronchodilator FEV1 % of predicted normal (part B) [ Time Frame: At week 6 and12, and every 3 months thereafter ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00641914 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pre-bronchodilator FEV1 % of predicted normal [ Time Frame: At week 6 and12, and every 3 months thereafter ]
HE: Asthma related events and health care utilisation, and symptom free days (SFD) [ Time Frame: At week 6 and12, and every 3 months thereafter ]
Post-bronchodilator FVC % of predicted [ Time Frame: At week 6 and12, and every 3 months thereafter ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Inhaled Steroid Treatment as Regular Therapy in Early Asthma

Official Title ^ICMJE

Inhaled Steroid Treatment As Regular Therapy in Early Asthma. A Study on the Effect of Early Intervention With Long-Term Inhaled Budesonide (Pulmicort Turbuhaler ® ) in Newly Diagnosed Asthma.

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: budesonide
Drug: Placebo

Study Arms / Comparison Groups

Publications *

O'Byrne PM, Pedersen S, Lamm CJ, Tan WC, Busse WW; START Investigators Group. Severe exacerbations and decline in lung function in asthma. Am J Respir Crit Care Med. 2009 Jan 1;179(1):19-24. Epub 2008 Oct 31.

* 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

6800

Completion Date

February 2003

Primary Completion Date

February 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

6 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00641914

Responsible Party

Lars-Göran Carlsson, AstraZeneca

Study ID Numbers ^ICMJE

SD-004-0111, D5254C00111

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	Romain Pauwels	Steering Committee Chairman
Study Chair:	William Busse	Steering Committee Chairman

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