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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
April 16, 2007
April 18, 2007
August 14, 2017
September 20, 2017
September 20, 2017
April 2007
January 19, 2010   (Final data collection date for primary outcome measure)
Efficacy as Assessed my Pulmonary Function Tests [ Time Frame: change from baseline to study completion ]
Not Provided
Complete list of historical versions of study NCT00461812 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Asthma
  • Drug: Mometasone
  • Drug: Advair
  • Experimental: Mometasone
    Intervention: Drug: Mometasone
  • Experimental: Advair
    Intervention: Drug: Advair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
33
January 19, 2010
January 19, 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00461812
NA_00001154
Yes
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
Schering-Plough
Principal Investigator: Peter S Creticos, MD Johns Hopkins University
Johns Hopkins University
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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