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Mometasone and Markers of Airway Inflammation

Sponsor
Creighton University (Other)
Overall Status
Completed
CT.gov ID
NCT00711165
Collaborator
Schering-Plough (Industry)
12
Enrollment
1
Location
2
Arms
12
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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

Study Type:
Interventional
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 :
Aug 1, 2005
Actual Primary Completion Date :
Apr 1, 2006
Actual Study Completion Date :
Aug 1, 2006

Arms and Interventions

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 Names:
  • asmanex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Exhaled Nitric Oxide [8 weeks]

    Secondary Outcome Measures

    1. Airway Reactivity [8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00711165
    Other Study ID Numbers:
    • Mometasone TBC
    First Posted:
    Jul 8, 2008
    Last Update Posted:
    Jul 8, 2008
    Last Verified:
    Jul 1, 2008
    Keywords provided by , ,
    Asthma
    Nitric Oxide
    Exhaled Breath Condensate
    Methacholine Challenge
    Additional relevant MeSH terms:
    Inflammation
    Mometasone Furoate

    Study Results

    No Results Posted as of Jul 8, 2008