Ventilatory Heterogeneity in Participants With Asthma (MK-0476-513)

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Montelukast; Drug: Prednisone

• Registration Number: NCT01621386
• Lead Sponsor: Hal C Charles

Brief Summary

This study will explore the utility of magnetic resonance imaging (MRI) to assess ventilatory defects that occur due to asthma, determine the sensitivity and specificity of MRI in response to drug treatment, and whether MRI can serve as a biomarker of treatment effects due to asthma therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-06-14
• Study First Posted: 2012-06-18
• Study Start: 2013-01
• Primary Completion: 2015-09
• Study Completion: 2016-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	Montelukast	Participants (male or female) that are between 18-65 years of age with a clinical diagnosis of asthma will take montelukast for 2 weeks (treatment period 1) and then take prednisone for 2 weeks (treatment period 2)
All Participants	Prednisone	Participants (male or female) that are between 18-65 years of age with a clinical diagnosis of asthma will take montelukast for 2 weeks (treatment period 1) and then take prednisone for 2 weeks (treatment period 2)

Primary Outcome Measures

Name	Time	Method
Change from baseline in VH assessed by oxygen-enhanced 1H MRI (Oe 1H MRI) after two weeks of montelukast or prednisone treatment	Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by 19F-perfluoropropane MRI (19F MRI) after two weeks of montelukast or prednisone treatment	Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Conducting Airway Heterogeneity (Scond) after two weeks of montelukast or prednisone treatment	Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Lung Clearance Index (LCI) after two weeks of montelukast or prednisone treatment	Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Forced Expiratory Volume in 1 second (FEV1) after two weeks of montelukast or prednisone treatment	Baseline and after two weeks of drug treatment

Secondary Outcome Measures

Name	Time	Method
Comparison of VH assessed by Oe 1H MRI, 19F MRI, LCI, Scond and FEV1 at baseline	Baseline
Short-term test-retest repeatability of VH by Oe 1H MRI and 19F MRI	Visit 2 and Visit 3
Mid-term test-retest repeatability of VH by Oe 1H MRI and 19F MRI	Visit 3 and Visit 4/Visit 5

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States