Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
219 participants
INTERVENTIONAL
2009-01-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
QUADRUPLE
Study Groups
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Low dose fluticasone for phase 2
For people with asthma, fluticasone at 250 mcg per day; phase 2 of study
fluticasone
Inhaled corticosteroid approved for treatment of asthma
High dose fluticasone for phase 2
For people with asthma, fluticasone at 1000 mcg per day; phase 2 of study
fluticasone
Inhaled corticosteroid approved for treatment of asthma
Nonasthmatic controls for phase 1
People without asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study
No interventions assigned to this group
Asthmatic controls for phase 1
People with asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study
No interventions assigned to this group
Interventions
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fluticasone
Inhaled corticosteroid approved for treatment of asthma
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Physician-diagnosed and investigator-confirmed stable asthma (excluding exercise induced asthma)
* Current treatment for asthma by a healthcare provider within the preceding twelve months: current asthma treatment defined as regular use of asthma medications. Asthma medications include short and long acting adrenergic bronchodilators, bronchodilator combinations, inhaled anticholinergics, inhaled corticosteroids, cromolyn sodium and nedocromil, leukotriene modifiers and methylxanthines
* Stable asthma defined by no asthma exacerbation (emergency room visit, hospitalization, course of increased systemic steroids, or urgent health care visit for asthma) during the prior four weeks
* Forced expiratory volume at one second (FEV1) \>70% predicted pre-bronchodilator
* Ability to provide screening and baseline information
* Ability and willingness to provide informed consent
* For women of childbearing potential: not pregnant, non-lactating, and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study
* Males or females greater than or equal to 12 and less than 70 years of age
* Individuals who are in good overall health
* Age (within ten years for above 25 years of age and +/- five years for 12-25 years of age) and sex matched to the asthmatic group
Exclusion Criteria
* Oral corticosteroid use within past 4 weeks
* Respiratory tract infection within past 4 weeks
* Chronic diseases (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, or nervous system, or immunodeficiency
* Known allergy to methacholine (for example, a previous bad reaction to methacholine) or to any other parasympathomimetic agents
* Current use of beta adrenergic blocking agent (a heart medicine) or a cholinesterase inhibitor (medicine used to treat myasthenia gravis or Alzheimer's disease).
* History of epilepsy, cardiovascular disease with bradycardia (slow heart beat), vagotonia (increased activity of the vagus nerve causing slow heart rate or low blood pressure), peptic ulcer disease, thyroid disease, or urinary tract obstruction
* History of cigarette smoking within the past 5 years or \>10 pack years total
* Use of investigative drugs or intervention trials in the 30 days prior to enrollment or during the duration of the study
* Any condition or compliance issue which in the opinion of the investigator might interfere with participation
Nonasthmatic control criteria:
* A subject will be excluded if there is a history within the previous 5 years of:
* clinically diagnosed allergy (allergic rhinitis, hay fever or atopic dermatitis),
* asthma (beyond 6 years of age),
* chronic nasal or sinus disease, or
* other chronic lung diseases
* Respiratory tract infection within past 4 weeks
* History of cigarette smoking within the past 5 years or \>10 pack years total
* Known allergy to methacholine (for example, a previous bad reaction to methacholine) or to any other parasympathomimetic agents
* Current use of beta adrenergic blocking agent (a heart medicine) or a cholinesterase inhibitor (medicine used to treat myasthenia gravis or Alzheimer's disease).
* History of epilepsy, cardiovascular disease with bradycardia (slow heart beat), vagotonia (increased activity of the vagus nerve causing slow heart rate or low blood pressure), peptic ulcer disease, thyroid disease, or urinary tract obstruction
12 Years
69 Years
ALL
Yes
Sponsors
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Washington University School of Medicine
OTHER
St. Louis University
OTHER
Long Island Jewish Medical Center
OTHER
North Shore University Hospital
OTHER
Baylor College of Medicine
OTHER
University of Vermont
OTHER
Nemours Children's Clinic
OTHER
University of Florida
OTHER
Indiana University
OTHER
Ohio State University
OTHER
NYU Langone Health
OTHER
University of Missouri-Columbia
OTHER
Northwestern University
OTHER
Louisiana State University Health Sciences Center in New Orleans
OTHER
University of Miami
OTHER
University of South Florida
OTHER
University of California, San Diego
OTHER
National Jewish Health
OTHER
Duke University
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Janet Holbrook
Associate Professor
Principal Investigators
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Kaharu Sumino, MD
Role: PRINCIPAL_INVESTIGATOR
St. Louis Asthma Clinical Research Center
Locations
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University of California at San Diego
San Diego, California, United States
The Nemours Children's Clinic
Jacksonville, Florida, United States
University of Miami/Univestiy of South Florida
Miami, Florida, United States
Northwestern University Memorial Hospital
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Louisianna State University
New Orleans, Louisiana, United States
University of Missouri-Kansas City
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
New York Consortium/Columbia University
New York, New York, United States
New York Medical College
Valhalla, New York, United States
Ohio State University
Columbus, Ohio, United States
Vermont Lung Center at the University of Vermont
Burlington, Vermont, United States
Countries
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References
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Sumino K, Sugar EA, Irvin CG, Kaminsky DA, Shade D, Wei CY, Holbrook JT, Wise RA, Castro M; American Lung Association Asthma Clinical Research Centers. Methacholine challenge test: diagnostic characteristics in asthmatic patients receiving controller medications. J Allergy Clin Immunol. 2012 Jul;130(1):69-75.e6. doi: 10.1016/j.jaci.2012.02.025. Epub 2012 Apr 1.
Related Links
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Asthma Clinical Research Centers website
Other Identifiers
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ALAACRC07
Identifier Type: -
Identifier Source: org_study_id
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