A Two-Week Study Assessing the Onset of Effect Questionnaire Administered Pre-Dose Versus Post-Dose in Adult Subjects - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00449501

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Budesonide/formoterol pMDI Drug: Budesonide HFA pMDI	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 Outcome Measures:

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

Enrollment:	134
Study Start Date:	March 2007
Study Completion Date:	November 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449501

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Locations

United States, Alabama
Research Site
Muscle Shoals, Alabama, United States
United States, Arkansas
Research Site
Little Rock, Arkansas, United States
United States, California
Research Site
Anaheim, California, United States
Research Site
Los Angeles, California, United States
Research Site
Palmdale, California, United States
Research Site
Rolling Hills Estates, California, United States
United States, Colorado
Research Site
Denver, Colorado, United States
Research Site
Wheat Ridge, Colorado, United States
United States, Connecticut
Research Site
Stamford, Connecticut, United States
United States, Delaware
Research Site
Wilmington, Delaware, United States
United States, Florida
Research Site
Miami, Florida, United States
United States, Indiana
Research Site
Avon, Indiana, United States
United States, Iowa
Research Site
Iowa City, Iowa, United States
United States, Kansas
Research Site
Shawnee Mission, Kansas, United States
United States, Louisiana
Research Site
Mandeville, Louisiana, United States
United States, Maryland
Research Site
Wheaton, Maryland, United States
United States, Michigan
Research Site
Bay City, Michigan, United States
United States, Missouri
Research Site
Chesterfield, Missouri, United States
Research Site
Kansas City, Missouri, United States
United States, Nebraska
Research Site
McCook, Nebraska, United States
Research Site
Scottsbluff, Nebraska, United States
United States, New Jersey
Research Site
Brick, New Jersey, United States
Research Site
Princeton, New Jersey, United States
United States, New York
Research Site
North Syracuse, New York, United States
United States, North Dakota
Research Site
Bismarck, North Dakota, United States
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Fargo, North Dakota, United States
United States, Ohio
Research Site
Akron, Ohio, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Oregon
Research Site
Bend, Oregon, United States
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Lake Oswego, Oregon, United States
United States, Pennsylvania
Research Site
Bensalem, Pennsylvania, United States
Research Site
Feasterville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
United States, Rhode Island
Research Site
East Providence, Rhode Island, United States
United States, South Carolina
Research Site
Charleston, South Carolina, United States
Research Site
Gaffney, South Carolina, United States
Research Site
Greer, South Carolina, United States
United States, South Dakota
Research Site
Rapid City, South Dakota, United States
Research Site
Watertown, South Dakota, United States
United States, Texas
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San Antonio, Texas, United States
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Waco, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
Boerne, Texas, United States
Research Site
Dallas, Texas, United States
United States, Utah
Research Site
Provo, Utah, United States
United States, Washington
Research Site
Spokane, Washington, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Tomas LG Andersson, MD

AstraZenenca

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	D5896C00025
Study First Received:	March 16, 2007
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00449501 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Mild Asthma
Moderate Asthma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Symbicort
Bronchial Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses

Formoterol
Immune System Diseases
Adrenergic beta-Agonists
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 22, 2009