A Two-week Study Assessing the Onset of Effect Questionnaire (OEQ) Administered Daily Versus Weekly in Adult Subjects
A Two-week, Randomised, Double-blind Study Assessing the Onset of Effect Questionnaire Administered Daily Versus Weekly in Adult Subjects (≥ 18 Years) With Mild to Moderate Asthma, Receiving SYMBICORT® pMDI 80/4.5 μg x 2 Actuations Twice Daily or Budesonide HFA pMDI 80 μg x 2 Actuations Twice Daily
1 other identifier
interventional
123
1 country
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Mar 2007
Shorter than P25 for phase_3 asthma
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 16, 2007
CompletedFirst Posted
Study publicly available on registry
March 20, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedJanuary 24, 2011
January 1, 2011
March 16, 2007
January 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (44)
Research Site
Tuscumbia, Alabama, United States
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Fort Smith, Arkansas, United States
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Long Beach, California, United States
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Orange, California, United States
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Riverside, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Valrico, Florida, United States
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River Forest, Illinois, United States
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Council Bluffs, Iowa, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Bowling Green, Kentucky, United States
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Florence, Kentucky, United States
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Metairie, Louisiana, United States
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City of Saint Peters, Missouri, United States
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St Louis, Missouri, United States
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Butte, Montana, United States
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Omaha, Nebraska, United States
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Papillion, Nebraska, United States
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Las Vegas, Nevada, United States
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Skillman, New Jersey, United States
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Summit, New Jersey, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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North Syracuse, New York, United States
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Rochester, New York, United States
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Greensboro, North Carolina, United States
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Mooresville, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Collegeville, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Spartanburg, South Carolina, United States
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Union, South Carolina, United States
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Dallas, Texas, United States
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South Burlington, Vermont, United States
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Bellingham, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
Related Publications (1)
Leidy NK, Gutierrez B, Lampl K, Uryniak T, O'Brien CD. Can patients with asthma feel inhaler therapy working right away? Two clinical trials testing the effect of timing of assessment on patient perception. J Asthma. 2009 Dec;46(10):1006-12. doi: 10.3109/02770900903301260.
PMID: 19995138DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tomas LG Andersson, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 16, 2007
First Posted
March 20, 2007
Study Start
March 1, 2007
Study Completion
August 1, 2007
Last Updated
January 24, 2011
Record last verified: 2011-01