Atlantis Symbicort - Tabular View

Tracking Information

First Received Date ^ICMJE

March 26, 2008

Last Updated Date

March 26, 2009

Start Date ^ICMJE

November 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Asthma control assessed by asthma exacerbations [ Time Frame: Continuosly throughout the treatment period ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00646594 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort. [ Time Frame: Daily and at 1, 3 and 6 months after start of treatmen ]
Use of medical resources and medication for the treatment of asthma. [ Time Frame: Throughout the treatment period ]
Investigate safety profile of Symbicort compared to Advair [ Time Frame: 1, 3 and 6 months after start of treatment and 1 week after end of tretment ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Atlantis Symbicort

Official Title ^ICMJE

A Two Stage Randomized, Open-Label, Parallel Group, Phase III, Multicenter, 7 Month Study to Assess the Efficacy & Safety of SYMBICORT pMDI Adminstered Either as Fixed or as an Adjustable Regimen Versus a Fixed Regimen of Advair in Subjects 12 Yrs of Age and Older With Asthma.

Brief Summary

The purpose of this study is to determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: budesonide/formoterol (Symbicort)
Drug: fluticasone/salmeterol (Advair)

Study Arms / Comparison Groups

Experimental: budesonide/formoterol
Active Comparator: fluticasone/salmeterol

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

1200

Completion Date

January 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of asthma
Baseline lung function tests as determined by protocol
Required and received treatment with inhaled corticosteroids within timeframe and doses specified in protocol

Exclusion Criteria:

Has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a beta-blockers
Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

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

NCT00646594

Responsible Party

Study ID Numbers ^ICMJE

D5896C00005

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Mitchell Golmand, MD	AstraZeneca
Study Chair:	Catherine Bonuccelli	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