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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00461812
Recruitment Status : Terminated (by sponsor due to failure to recruit patients who had mild persistent asthma who were not already on Advair 250/50 or 500/50.)
First Posted : April 18, 2007
Results First Posted : September 20, 2017
Last Update Posted : September 20, 2017
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Asthma Drug: Mometasone Drug: Advair Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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
Actual Study Start Date : April 2007
Actual Primary Completion Date : January 19, 2010
Actual Study Completion Date : January 19, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mometasone Drug: Mometasone
Experimental: Advair Drug: Advair


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy as Assessed my Pulmonary Function Tests [ Time Frame: change from baseline to study completion ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461812


Locations
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United States, Maryland
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Schering-Plough
Investigators
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Principal Investigator: Peter S Creticos, MD Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00461812    
Other Study ID Numbers: NA_00001154
First Posted: April 18, 2007    Key Record Dates
Results First Posted: September 20, 2017
Last Update Posted: September 20, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents