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Mometasone and Markers of Airway Inflammation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00711165
First Posted: July 8, 2008
Last Update Posted: July 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Schering-Plough
Information provided by:
Creighton University
  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: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Mometasone on Markers of Airway Inflammation

Resource links provided by NLM:


Further study details as provided by Creighton University:

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

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

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

Information from the National Library of Medicine

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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
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
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

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
First Submitted: July 3, 2008
First Posted: July 8, 2008
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:
Inflammation
Pathologic Processes
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents