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

This study is currently recruiting participants.

Verified by Johns Hopkins University, April 2007

First Received: April 16, 2007 No Changes Posted

Sponsor:	Johns Hopkins University
Collaborator:	Schering-Plough
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00461812

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Mometasone or Advair	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:	A Single-Blind, Randomized, Positive-Controlled Study to Compare Monotherapy With an Inhaled Corticosteroid (Mometasone) to Combination Therapy With an Inhaled Corticosteroid + a Long-Acting Bronchodilator (Advair) in Patients With Milder Persistent Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Mometasone furoate Advair

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Estimated Enrollment:	45
Study Start Date:	April 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461812

Contacts

Contact: Arouna P Khattignavong, MD	410-550-2184	akhatti1@jhmi.edu
Contact: Susan L Balcer Whaley, MPH	410-550-2122	swhaley1@jhmi.edu

Locations

United States, Maryland
Johns Hopkins Asthma and Allergy Center	Recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: Peter S Creticos, MD

Sponsors and Collaborators

Johns Hopkins University

Schering-Plough

Investigators

Principal Investigator:

Peter S Creticos, MD

Johns Hopkins University

More Information

No publications provided

Study ID Numbers:	NA_00001154
Study First Received:	April 16, 2007
Last Updated:	April 16, 2007
ClinicalTrials.gov Identifier:	NCT00461812 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Bronchial Diseases
Immune System Diseases
Mometasone furoate
Asthma
Anti-Allergic Agents
Pharmacologic Actions

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010