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Mometasone and Markers of Airway Inflammation

NCT ID: NCT00711165

Last Updated: 2008-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Asthma

Keywords

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Asthma Nitric Oxide Exhaled Breath Condensate Methacholine Challenge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Placebo, 2 puffs, bid

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 puffs, qd

Memetasone

Mometasone

Group Type EXPERIMENTAL

Mometasone Furoate

Intervention Type DRUG

400 mcg, qd for 8 weeks

Interventions

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Placebo

2 puffs, qd

Intervention Type DRUG

Mometasone Furoate

400 mcg, qd for 8 weeks

Intervention Type DRUG

Other Intervention Names

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asmanex

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy or lactation
* Corticosteroid use in past 30 days
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schering-Plough

INDUSTRY

Sponsor Role collaborator

Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Creighton University

Principal Investigators

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Thomas B Casale, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton University Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 19663124 (View on PubMed)

Other Identifiers

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Mometasone TBC

Identifier Type: -

Identifier Source: org_study_id