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

NCT ID: NCT00461812

Last Updated: 2017-09-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-01-19

Brief Summary

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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

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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Mometasone

Group Type EXPERIMENTAL

Mometasone

Intervention Type DRUG

Advair

Group Type EXPERIMENTAL

Advair

Intervention Type DRUG

Interventions

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Mometasone

Intervention Type DRUG

Advair

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schering-Plough

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter S Creticos, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00001154

Identifier Type: -

Identifier Source: org_study_id