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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Johns Hopkins University.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Mometasone or Advair
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Estimated Enrollment: 45
Study Start Date: April 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461812

Contacts
Contact: Arouna P Khattignavong, MD 410-550-2184 akhatti1@jhmi.edu
Contact: Susan L Balcer Whaley, MPH 410-550-2122 swhaley1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Asthma and Allergy Center Recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: Peter S Creticos, MD         
Sponsors and Collaborators
Johns Hopkins University
Schering-Plough
Investigators
Principal Investigator: Peter S Creticos, MD Johns Hopkins University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00461812     History of Changes
Other Study ID Numbers: NA_00001154
Study First Received: April 16, 2007
Last Updated: April 16, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone furoate
Fluticasone, salmeterol drug combination
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 01, 2014