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

Johns Hopkins University

Status and phase: Terminated; Phase 4

Conditions: Asthma

Treatments: Drug: Mometasone; Drug: Advair

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00461812

NA_00001154

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33 participants in 2 patient groups

Mometasone

Experimental group

Treatment:

Drug: Mometasone

Advair

Experimental group

Treatment:

Drug: Advair