Symbicort Onset of Action 1

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: fluticasone/salmeterol (Advair Diskus); Drug: albuterol (Ventolin); Drug: budesonide/formoterol (Symbicort)

• Registration Number: NCT00646620
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study Completion: 2003-09
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-03-28
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-03
• Last Update Posted: 2009-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Diagnosis of asthma and baseline lung function test results as determined by protocol
• Required and received asthma maintenance therapy within previous 4 weeks at doses determined by protocol

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Exclusion Criteria

• Severe asthma or asthma markedly affected by seasonal factors
• Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	fluticasone/salmeterol (Advair Diskus)	fluticasone/salmeterol
3	albuterol (Ventolin)	albuterol
1	budesonide/formoterol (Symbicort)	budesonide/formoterol

Primary Outcome Measures

Name	Time	Method
FEV1 3 minutes post dose	4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)

Secondary Outcome Measures

Name	Time	Method
12 hour serial FEV1	4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
Patients perception of effect	4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)