Mometasone and Markers of Airway Inflammation

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: Mometasone Furoate

• Registration Number: NCT00711165
• Lead Sponsor: Creighton University

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.

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2006-04
• Study Completion: 2006-08
• Status Verified: 2008-07
• Study First Submitted: 2008-07-03
• Study First Submitted QC: 2008-07-03
• Last Update Submitted: 2008-07-03
• Study First Posted: 2008-07-08
• Last Update Posted: 2008-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy or lactation
• Corticosteroid use in past 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo, 2 puffs, bid
Memetasone	Mometasone Furoate	Mometasone

Primary Outcome Measures

Name	Time	Method
Exhaled Nitric Oxide	8 weeks

Secondary Outcome Measures

Name	Time	Method
Airway Reactivity	8 weeks

Trial Locations

Locations (1)

Creighton University Medical Center; 🇺🇸 Omaha, Nebraska, United States