A Two-week Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects

NCT ID: NCT00449501

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Budesonide/formoterol pMDI

Intervention Type DRUG

Budesonide HFA pMDI

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Tomas LG Andersson, MD

Role: STUDY_DIRECTOR

AstraZenenca

Locations

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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

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Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 19995138 (View on PubMed)

Related Links

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Other Identifiers

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D5896C00025

Identifier Type: -

Identifier Source: org_study_id

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