Study Results
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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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2004-05-31
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo tablets for 2 weeks followed by fluticasone nasal drops 800mcg/d for 2 months followed by fluticasone nasal spray 400 mcg/d for 4 months
Placebo
tablets once daily
fluticasone nasal drops
fluticasone nasal drops 800mcg/d
fluticasone nasal spray
fluticasone nasal spray 400 mcg/d
Prednisolone
25 mg Prednisolone OD for 2 weeks followed by Fluticasone nasal drops 800 mcg/d for 2 months, followed by fluticasone nasal spray 400mcg/day for 4 months
Prednisolone
tablets 25 mg/day
fluticasone nasal drops
fluticasone nasal drops 800mcg/d
fluticasone nasal spray
fluticasone nasal spray 400 mcg/d
Interventions
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Prednisolone
tablets 25 mg/day
Placebo
tablets once daily
fluticasone nasal drops
fluticasone nasal drops 800mcg/d
fluticasone nasal spray
fluticasone nasal spray 400 mcg/d
Eligibility Criteria
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Inclusion Criteria
* 18-75 years of age
* bilateral nasal polyposis Grade 2 and above
* with or without asthma
* with or without atopy or aspirin sensitivity
* written informed consent
Exclusion Criteria
* polypoid lesion suspicious of inverted papilloma, malignancy, Wegeners granulomatosis, sarcoidosis
* known or suspected hypersensitivity to fluticasone propionate or any other constituents of the Investigational Medicinal product (IMP).
* Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study.
* significant (≥50%)septal deviation
* inability to comply with the requirements of the protocol
* females who are pregnant, lactating or planning to become pregnant.
18 Years
75 Years
ALL
No
Sponsors
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Chief Scientist Office of the Scottish Government
OTHER_GOV
NHS Tayside
OTHER_GOV
University of Dundee
OTHER
Responsible Party
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University of Dundee
Principal Investigators
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Sriram Vaidyanathan, MRCS
Role: PRINCIPAL_INVESTIGATOR
University of Dundee
Brian J Lipworth, MD
Role: STUDY_DIRECTOR
University of Dundee
Locations
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Ninewells Hospital and Medical School
Dundee, Angus, United Kingdom
Countries
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References
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Williamson PA, Vaidyanathan S, Clearie K, Barnes M, Lipworth BJ. Airway dysfunction in nasal polyposis: a spectrum of asthmatic disease? Clin Exp Allergy. 2011 Oct;41(10):1379-85. doi: 10.1111/j.1365-2222.2011.03793.x. Epub 2011 Jun 16.
Vaidyanathan S, Barnes M, Williamson P, Hopkinson P, Donnan PT, Lipworth B. Treatment of chronic rhinosinusitis with nasal polyposis with oral steroids followed by topical steroids: a randomized trial. Ann Intern Med. 2011 Mar 1;154(5):293-302. doi: 10.7326/0003-4819-154-5-201103010-00003.
Other Identifiers
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GRAY07
Identifier Type: -
Identifier Source: org_study_id