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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Johns Hopkins University.
Recruitment status was:  Recruiting
Information provided by:
Johns Hopkins University Identifier:
First received: April 16, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted

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
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

Further study details as provided by Johns Hopkins University:

Estimated Enrollment: 45
Study Start Date: April 2007

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00461812

Contact: Arouna P Khattignavong, MD 410-550-2184
Contact: Susan L Balcer Whaley, MPH 410-550-2122

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
Principal Investigator: Peter S Creticos, MD Johns Hopkins University
  More Information Identifier: NCT00461812     History of Changes
Other Study ID Numbers: NA_00001154
Study First Received: April 16, 2007
Last Updated: April 16, 2007

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Mometasone Furoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics processed this record on August 21, 2017