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Mometasone and Markers of Airway Inflammation

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Mometasone Furoate
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Nitric Oxide, Exhaled Breath Condensate, Methacholine Challenge

Eligibility Criteria

19 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Asthma
  • non-smoker
  • FEV1 of at least 60% predicted

Exclusion Criteria:

  • Pregnancy or lactation
  • Corticosteroid use in past 30 days

Sites / Locations

  • Creighton University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Memetasone

Arm Description

Placebo, 2 puffs, bid

Mometasone

Outcomes

Primary Outcome Measures

Exhaled Nitric Oxide

Secondary Outcome Measures

Airway Reactivity

Full Information

First Posted
July 3, 2008
Last Updated
July 3, 2008
Sponsor
Creighton University
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00711165
Brief Title
Mometasone and Markers of Airway Inflammation
Official Title
The Effects of Mometasone on Markers of Airway Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Creighton University
Collaborators
Schering-Plough

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Nitric Oxide, Exhaled Breath Condensate, Methacholine Challenge

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 2 puffs, bid
Arm Title
Memetasone
Arm Type
Experimental
Arm Description
Mometasone
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 puffs, qd
Intervention Type
Drug
Intervention Name(s)
Mometasone Furoate
Other Intervention Name(s)
asmanex
Intervention Description
400 mcg, qd for 8 weeks
Primary Outcome Measure Information:
Title
Exhaled Nitric Oxide
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Airway Reactivity
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Asthma non-smoker FEV1 of at least 60% predicted Exclusion Criteria: Pregnancy or lactation Corticosteroid use in past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas B Casale, MD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19663124
Citation
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.
Results Reference
derived

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Mometasone and Markers of Airway Inflammation

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