Conditions: Asthma
Keywords: Normal Controls
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 219
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: For people with asthma, fluticasone at 250 mcg per day; phase 2 of study arm 2: For people with asthma, fluticasone at 1000 mcg per day; phase 2 of study arm 3: People without asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study arm 4: People with asthma will be enrolled to perform 1 methacholine challenge test in phase 1 of the study

Interventions: intervention 1: fluticasone
Intervention descriptions: intervention 1: Inhaled corticosteroid approved for treatment of asthma

Protocol document: