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:


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
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 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-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 28, 2014