Study 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.
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
1 other identifier
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 asthma
Started Apr 2007
Typical duration for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 16, 2007
CompletedFirst Posted
Study publicly available on registry
April 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2010
CompletedResults Posted
Study results publicly available
September 20, 2017
CompletedSeptember 20, 2017
September 1, 2017
2.8 years
April 16, 2007
August 14, 2017
September 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy as Assessed my Pulmonary Function Tests
change from baseline to study completion
Study Arms (2)
Mometasone
EXPERIMENTALAdvair
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- subjects 18 to 65 years of age
- a \>2 year history of asthma
- FEV1 \> 80% for subjects currently using Advair®.
You may not qualify if:
- severe asthma
- current smokers
- pregnant or breast-feeding women
- other chronic significant illnesses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- Schering-Ploughcollaborator
Study Sites (1)
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, 21224, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Johns Hopkins University Clinical Trials Program
- Organization
- Johns Hopkins University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Peter S Creticos, MD
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2007
First Posted
April 18, 2007
Study Start
April 1, 2007
Primary Completion
January 19, 2010
Study Completion
January 19, 2010
Last Updated
September 20, 2017
Results First Posted
September 20, 2017
Record last verified: 2017-09