Gemini Symbicort pMDI

Phase 3

Completed

• Conditions: Mild or Moderate Asthma
• Interventions: Drug: budesonide/formoterol (Symbicort)

• Registration Number: NCT00646516
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will improve lung function and symptoms of adults and adolescents with asthma.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study Completion: 2005-02
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-03-28
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 615

Inclusion Criteria

• Diagnosis of asthma
• Baseline lung function tests as determined by protocol.
• Required and received treatment with inhaled corticosteroids and/or lung treatments specified in the protocol within timeframe and doses specified in protocol.

Exclusion Criteria

• Severe asthma
• Has required treatment with any non-inhaled corticosteroid within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
• Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	budesonide/formoterol (Symbicort)	-

Primary Outcome Measures

Name	Time	Method
Change from start of treatment in evening pre-dose FEV1	2, 6 and 12 weeks after starting treatment

Secondary Outcome Measures

Name	Time	Method
Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes	Daily
Investigate safety profile of Symbicort and budesonide	Before and 2, 4, 12 weeks after start of treatment and 1 week after end of treatment