A Comparison of Mometasone to Advair in Patients With Milder Persistent Asthma
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Mometasone or Advair (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): Peter S Creticos, MD, Principal Investigator, Affiliation: Johns Hopkins University
Overall contact: Arouna P Khattignavong, MD, Phone: 410-550-2184, Email: akhatti1@jhmi.edu
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.
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Arouna P Khattignavong, MD, Phone: 410-550-2184, Email: akhatti1@jhmi.edu
Johns Hopkins Asthma and Allergy Center, Baltimore, Maryland 21224, United States; Recruiting Peter S Creticos, MD, Principal Investigator
Additional Information
Starting date: April 2007
Last updated: April 16, 2007
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