A Two-week Study Assessing the Onset of Effect Questionnaire (OEQ) Administered Daily Versus Weekly in Adult Subjects

Phase 3

Completed

• Conditions: Asthma

• Registration Number: NCT00449527
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) using a 1 week recall period versus a 1 day recall period.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-16
• Study First Submitted QC: 2007-03-19
• Study First Posted: 2007-03-20
• Study Completion: 2007-08
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Male or Female, > 18 years of age
• Mild to moderate asthma requiring treatment with an inhaled corticosteroid
• Diagnosis of asthma for at least 6 months

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Exclusion Criteria

• Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
• Subjects with severe asthma, as judged by investigator
• Any significant disease or disorder that may jeopardize a subject's safety

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) items 2 and 5 using a 1 week recall period versus a 1 day recall period.

Secondary Outcome Measures

Name	Time	Method
To demonstrate the value to subjects of feeling an asthma maintenance medication begins to work right away; to assess the correlation between subject's responses to weekly/daily Onset of Effect Questionnaires with lung function and with diary variables.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Tacoma, Washington, United States