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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2007 by Johns Hopkins University
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00461812
First received: April 16, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted

April 16, 2007
April 16, 2007
April 2007
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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 Blind
Primary Purpose: Treatment
Asthma
Drug: Mometasone or Advair
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
Not Provided
Not Provided

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: Arouna P Khattignavong, MD 410-550-2184 akhatti1@jhmi.edu
Contact: Susan L Balcer Whaley, MPH 410-550-2122 swhaley1@jhmi.edu
United States
 
 
NCT00461812
NA_00001154
Yes
Not Provided
Not Provided
Not Provided
Not Provided
Johns Hopkins University
Schering-Plough
Principal Investigator: Peter S Creticos, MD Johns Hopkins University
Johns Hopkins University
April 2007

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