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Mometasone and Markers of Airway Inflammation

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ClinicalTrials.gov Identifier: NCT00711165
Recruitment Status : Completed
First Posted : July 8, 2008
Last Update Posted : July 8, 2008
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Creighton University

Study Description
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Brief Summary:
A post-marketing study to look at the effects of Asmanex on markers of airway inflammation.

Condition or disease Intervention/treatment Phase
Asthma Drug: Placebo Drug: Mometasone Furoate Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Mometasone on Markers of Airway Inflammation
Study Start Date : August 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Exhaled Nitric Oxide [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Airway Reactivity [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00711165


Locations
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United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Schering-Plough
Investigators
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Principal Investigator: Thomas B Casale, MD Creighton University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Thomas B. Casale, MD, Creighton University
ClinicalTrials.gov Identifier: NCT00711165    
Other Study ID Numbers: Mometasone TBC
First Posted: July 8, 2008    Key Record Dates
Last Update Posted: July 8, 2008
Last Verified: July 2008
Keywords provided by Creighton University:
Asthma
Nitric Oxide
Exhaled Breath Condensate
Methacholine Challenge
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Mometasone Furoate
 Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents