Atlantis Symbicort

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00646594

Collaborator

(none)

1,200

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: budesonide/formoterol (Symbicort) Drug: fluticasone/salmeterol (Advair)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Nov 1, 2003

Actual Study Completion Date :

Jan 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 budesonide/formoterol	Drug: budesonide/formoterol (Symbicort) Other Names: Symbicort
Active Comparator: 2 fluticasone/salmeterol	Drug: fluticasone/salmeterol (Advair) Other Names: Advair

Arm

Intervention/Treatment

Experimental: 1

budesonide/formoterol

Drug: budesonide/formoterol (Symbicort)

Other Names:

Symbicort

Active Comparator: 2

fluticasone/salmeterol

Drug: fluticasone/salmeterol (Advair)

Other Names:

Advair

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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. [Daily and at 1, 3 and 6 months after start of treatmen]
Use of medical resources and medication for the treatment of asthma. [Throughout the treatment period]
Investigate safety profile of Symbicort compared to Advair [1, 3 and 6 months after start of treatment and 1 week after end of tretment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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