A Two-week Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects
A Two-week, Randomised, Double-blind Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose 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 Act. Twice Daily
1 other identifier
interventional
134
1 country
46
Brief Summary
The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) administered pre-dose versus post-dose, while receiving SYMBICORT® pMDI 80/4.5 μg x 2 actuations twice daily or budesonide HFA pMDI 80 μg x 2 actuations twice daily.
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
46 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
November 1, 2007
CompletedJanuary 24, 2011
January 1, 2011
March 16, 2007
January 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine whether subjects respond similarly to the Onset of Effect Questionnaire items 2 and 5 when administered post-dose versus pre-dose and does that difference favour a bronchodilator treatment group over a non-bronchodilator treatment group
Secondary Outcomes (1)
To determine if there is an association between the immediate physiological response to medication and the responses to OEQ items 2 and 5 and to determine what subjects mean when they say they feel their asthma maintenance medication 'working right away
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 (46)
Research Site
Muscle Shoals, Alabama, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Los Angeles, California, United States
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Palmdale, California, United States
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Rolling Hills Estates, California, United States
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Denver, Colorado, United States
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Wheat Ridge, Colorado, United States
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Stamford, Connecticut, United States
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Wilmington, Delaware, United States
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Miami, Florida, United States
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Avon, Indiana, United States
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Iowa City, Iowa, United States
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Shawnee Mission, Kansas, United States
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Mandeville, Louisiana, United States
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Wheaton, Maryland, United States
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Bay City, Michigan, United States
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Chesterfield, Missouri, United States
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Kansas City, Missouri, United States
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McCook, Nebraska, United States
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Scottsbluff, Nebraska, United States
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Brick, New Jersey, United States
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Princeton, New Jersey, United States
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North Syracuse, New York, United States
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Bismarck, North Dakota, United States
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Fargo, North Dakota, United States
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Akron, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Bend, Oregon, United States
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Lake Oswego, Oregon, United States
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Bensalem, Pennsylvania, United States
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Feasterville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Gaffney, South Carolina, United States
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Greer, South Carolina, United States
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Rapid City, South Dakota, United States
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Watertown, South Dakota, United States
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Boerne, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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San Antonio, Texas, United States
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Waco, Texas, United States
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Provo, Utah, United States
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Spokane, 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
AstraZenenca
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
November 1, 2007
Last Updated
January 24, 2011
Record last verified: 2011-01