NCT00705341

MethaCholine Bronchoprovocation Study (MeCIS)

MethaCholine Bronchoprovocation - Influence of High Potency Inhaled corticoSteroids in Asthma (MeCIS) Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 12 Years – 69 Years
• Healthy volunteers: Accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	fluticasone	Inhaled corticosteroid approved for treatment of asthma

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2008-06-26
• Last updated: 2013-02-12
• Results posted: 2013-02-12

Locations

13 sites across 1 country: United States