The purpose of this research is to evaluate the methacholine challenge test as an accurate indicator of asthma in patients receiving treatment for asthma. Phase 1 on the study compares methacholine challenge test results from asthma patients to those from people who do not have asthma. In phase 2, test results for people with asthma on low dose inhaled corticosteroid will be compared to results on high dose inhaled corticosteroids. Both males and females with stable asthma (asthma participants) and without asthma (controls) enrolled. Participants will be between 12 and 69 years of age.
The study consists of two phases. The first phase is a cross-sectional, case-control study measuring the sensitivity and specificity of methacholine challenge testing for differentiating asthmatic participants from non-asthmatic controls. The second phase is a cross-over, randomized, double-masked trial designed to evaluate the impact of high dose versus low dose inhaled corticosteroids (ICS) on bronchial hyperreactivity (BHR) in asthmatics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
219
Inhaled corticosteroid approved for treatment of asthma
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
Methacholine Challenge Test Result for Phase 2
Presence and degree of airway hyperresponsiveness assessed by methacholine challenge test post-diluent baseline (PC20) after medication holds; PC20 is the methacholine dose at which the amount of air expired in the first second during a forced expiratory maneuver is reduced by 20%; value represents change in baseline to 4 weeks
Time frame: weeks 0, 4
Predictive Value of Methacholine Challenge Test for Phase 1
Predictive value of methacholine challenge test in phase 1 for asthmatics and nonasthmatic controls
Time frame: one time
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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
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