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:

Drug Information available for: Mometasone furoate Mometasone furoate monohydrate

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 (Adult)
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

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

Mehta V, Stokes JR, Berro A, Romero FA, Casale TB. Time-dependent effects of inhaled corticosteroids on lung function, bronchial hyperresponsiveness, and airway inflammation in asthma. Ann Allergy Asthma Immunol. 2009 Jul;103(1):31-7. doi: 10.1016/S1081-1206(10)60140-8.


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:


Inflammation Pathologic Processes Mometasone Furoate	Anti-Inflammatory Agents Dermatologic Agents Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 30, 2016

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