Mometasone and Markers of Airway Inflammation
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| ClinicalTrials.gov Identifier: NCT00711165 |
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Recruitment Status :
Completed
First Posted : July 8, 2008
Last Update Posted : July 8, 2008
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Sponsor:
Creighton University
Collaborator:
Schering-Plough
Information provided by:
Creighton University
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Brief Summary:
A post-marketing study to look at the effects of Asmanex on markers of airway inflammation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma | Drug: Placebo Drug: Mometasone Furoate | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 12 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | The Effects of Mometasone on Markers of Airway Inflammation |
| Study Start Date : | August 2005 |
| Actual Primary Completion Date : | April 2006 |
| Actual Study Completion Date : | August 2006 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Placebo, 2 puffs, bid
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Drug: Placebo
2 puffs, qd
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Experimental: Memetasone
Mometasone
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Drug: Mometasone Furoate
400 mcg, qd for 8 weeks
Other Name: asmanex
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Primary Outcome Measures :
- Exhaled Nitric Oxide [ Time Frame: 8 weeks ]
Secondary Outcome Measures :
- Airway Reactivity [ Time Frame: 8 weeks ]
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| Ages Eligible for Study: | 19 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
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 |
| First Posted: | July 8, 2008 Key Record Dates |
| Last Update Posted: | July 8, 2008 |
| Last Verified: | July 2008 |
Keywords provided by Creighton University:
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Asthma Nitric Oxide Exhaled Breath Condensate Methacholine Challenge |
Additional relevant MeSH terms:
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Inflammation Pathologic Processes Mometasone Furoate |
Anti-Inflammatory Agents Dermatologic Agents Anti-Allergic Agents |