Back to resultsA Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma
Primary Purpose
Asthma
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mometasone
Advair
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility 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
Sites / Locations
- Johns Hopkins Asthma and Allergy Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mometasone
Advair
Arm Description
Outcomes
Primary Outcome Measures
Efficacy as Assessed my Pulmonary Function Tests
Secondary Outcome Measures
Full Information
NCT ID
NCT00461812
First Posted
April 16, 2007
Last Updated
September 19, 2017
Sponsor
Johns Hopkins University
Collaborators
Schering-Plough
1. Study Identification
Unique Protocol Identification Number
NCT00461812
Brief Title
A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
by sponsor due to failure to recruit patients who had mild persistent asthma who were not already on Advair 250/50 or 500/50.
Study Start Date
April 2007 (Actual)
Primary Completion Date
January 19, 2010 (Actual)
Study Completion Date
January 19, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Schering-Plough
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mometasone
Arm Type
Experimental
Arm Title
Advair
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mometasone
Intervention Type
Drug
Intervention Name(s)
Advair
Primary Outcome Measure Information:
Title
Efficacy as Assessed my Pulmonary Function Tests
Time Frame
change from baseline to study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter S Creticos, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Asthma and Allergy Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma
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