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Mometasone and Markers of Airway Inflammation

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00711165
First received: July 3, 2008
Last updated: NA
Last verified: July 2008
History: No changes posted
  Purpose

A post-marketing study to look at the effects of Asmanex on markers of airway inflammation.


Condition Intervention Phase
Asthma
 Drug: Placebo
Drug: Mometasone Furoate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Mometasone on Markers of Airway Inflammation

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Exhaled Nitric Oxide [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Airway Reactivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: August 2005
Study Completion Date: August 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo, 2 puffs, bid
 Drug: Placebo
2 puffs, qd
Experimental: Memetasone
Mometasone
 Drug: Mometasone Furoate
400 mcg, qd for 8 weeks
Other Name: asmanex

Detailed Description:

Patients with asthma and not treated with anti-inflammatory medications were studied. This was a parallel, randomized, placebo-controlled study to investigate the effects of Asmanex on markers of airway inflammation including exhaled nitric oxide, airway reactivity, FEV1 and nitrates/nitrites and pH in exhaled breath condensate.

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asthma
  • non-smoker
  • FEV1 of at least 60% predicted

Exclusion Criteria:

  • Pregnancy or lactation
  • Corticosteroid use in past 30 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711165

Locations
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Schering-Plough
Investigators
Principal Investigator: Thomas B Casale, MD Creighton University
  More Information

No publications provided by Creighton University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Thomas B. Casale, MD, Creighton University
ClinicalTrials.gov Identifier: NCT00711165     History of Changes
Other Study ID Numbers: Mometasone TBC
Study First Received: July 3, 2008
Last Updated: July 3, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Asthma
Nitric Oxide
Exhaled Breath Condensate
Methacholine Challenge

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
 Hypersensitivity
Immune System Diseases
Pathologic Processes
Mometasone furoate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013