A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma

Phase 4

Terminated

• Conditions: Asthma
• Interventions: Drug: Mometasone; Drug: Advair

• Registration Number: NCT00461812
• Lead Sponsor: Johns Hopkins University

Brief Summary

The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in control of mild persistent asthma?

The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent asthma.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-16
• Study First Submitted QC: 2007-04-16
• Study First Posted: 2007-04-18
• Primary Completion: 2010-01-19
• Study Completion: 2010-01-19
• Results First Submitted: 2017-08-14
• Status Verified: 2017-09
• Results First Submitted QC: 2017-09-19
• Last Update Submitted: 2017-09-19
• Results First Posted: 2017-09-20
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• subjects 18 to 65 years of age
• a >2 year history of asthma
• FEV1 > 80% for subjects currently using Advair®.

Exclusion Criteria

• severe asthma
• current smokers
• pregnant or breast-feeding women
• other chronic significant illnesses

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mometasone	Mometasone	-
Advair	Advair	-

Primary Outcome Measures

Name	Time	Method
Efficacy as Assessed my Pulmonary Function Tests	change from baseline to study completion

Trial Locations

Locations (1)

Johns Hopkins Asthma and Allergy Center; 🇺🇸 Baltimore, Maryland, United States