Symbicort Onset of Action 2

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: budesonide/formoterol; Drug: fluticasone/salmeterol; Drug: albuterol

• Registration Number: NCT00646009
• 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: 2003-03
• Study Completion: 2003-08
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-26
• 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: 48

Inclusion Criteria

• At least 18 years of age
• Diagnosis of asthma and baseline lung function test results as determined by the protocol
• Required and received inhaled corticosteroids within timeframe and doses specified in the protocol

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	budesonide/formoterol	budesonide/formoterol
2	fluticasone/salmeterol	fluticasone/salmeterol
3	albuterol	albuterol

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	Patients perception of effect