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

This study has been 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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461812
First Posted: April 18, 2007
Last Update Posted: September 20, 2017
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.
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Johns Hopkins University
  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 Drug: Advair Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by Johns Hopkins University:

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

Enrollment: 33
Actual Study Start Date: April 2007
Study Completion Date: January 19, 2010
Primary Completion Date: January 19, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mometasone Drug: Mometasone
Experimental: Advair Drug: Advair

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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
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
United States, Maryland
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Schering-Plough
Investigators
Principal Investigator: Peter S Creticos, MD Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00461812     History of Changes
Other Study ID Numbers: NA_00001154
First Submitted: April 16, 2007
First Posted: April 18, 2007
Results First Submitted: August 14, 2017
Results First Posted: September 20, 2017
Last Update Posted: September 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone Furoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics