- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00449527
A Two-week Study Assessing the Onset of Effect Questionnaire (OEQ) Administered Daily Versus Weekly in Adult Subjects
January 21, 2011 updated by: AstraZeneca
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
123
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Tuscumbia, Alabama, United States
- Research Site
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Arkansas
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Fort Smith, Arkansas, United States
- Research Site
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California
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Long Beach, California, United States
- Research Site
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Orange, California, United States
- Research Site
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Riverside, California, United States
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Sacramento, California, United States
- Research Site
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San Diego, California, United States
- Research Site
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San Jose, California, United States
- Research Site
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Colorado
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Colorado Springs, Colorado, United States
- Research Site
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Denver, Colorado, United States
- Research Site
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Florida
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Valrico, Florida, United States
- Research Site
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Illinois
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River Forest, Illinois, United States
- Research Site
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Iowa
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Council Bluffs, Iowa, United States
- Research Site
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Kansas
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Topeka, Kansas, United States
- Research Site
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Wichita, Kansas, United States
- Research Site
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Kentucky
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Bowling Green, Kentucky, United States
- Research Site
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Florence, Kentucky, United States
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Louisiana
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Metairie, Louisiana, United States
- Research Site
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Missouri
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St. Louis, Missouri, United States
- Research Site
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St. Peters, Missouri, United States
- Research Site
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Montana
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Butte, Montana, United States
- Research Site
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Nebraska
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Omaha, Nebraska, United States
- Research Site
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Papillion, Nebraska, United States
- Research Site
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Nevada
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Las Vegas, Nevada, United States
- Research Site
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New Jersey
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Skillman, New Jersey, United States
- Research Site
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Summit, New Jersey, United States
- Research Site
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New Mexico
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Albuquerque, New Mexico, United States
- Research Site
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New York
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New York, New York, United States
- Research Site
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North Syracuse, New York, United States
- Research Site
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Rochester, New York, United States
- Research Site
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North Carolina
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Greensboro, North Carolina, United States
- Research Site
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Mooresville, North Carolina, United States
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Oklahoma
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Oklahoma City, Oklahoma, United States
- Research Site
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Tulsa, Oklahoma, United States
- Research Site
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Pennsylvania
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Collegeville, Pennsylvania, United States
- Research Site
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South Carolina
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Charleston, South Carolina, United States
- Research Site
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Greenville, South Carolina, United States
- Research Site
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Spartanburg, South Carolina, United States
- Research Site
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Union, South Carolina, United States
- Research Site
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Texas
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Dallas, Texas, United States
- Research Site
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Vermont
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South Burlington, Vermont, United States
- Research Site
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Washington
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Bellingham, Washington, United States
- Research Site
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Spokane, Washington, United States
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Tacoma, Washington, United States
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tomas LG Andersson, MD, AstraZeneca
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
March 16, 2007
First Submitted That Met QC Criteria
March 19, 2007
First Posted (Estimate)
March 20, 2007
Study Record Updates
Last Update Posted (Estimate)
January 24, 2011
Last Update Submitted That Met QC Criteria
January 21, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Budesonide
- Formoterol Fumarate
Other Study ID Numbers
- D5896C00023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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