Status:
COMPLETED
Medical Polypectomy and Predictors of Response
Lead Sponsor:
University of Dundee
Collaborating Sponsors:
Chief Scientist Office of the Scottish Government
NHS Tayside
Conditions:
Nasal Polyps
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This is the first randomized parallel group clinical trial looking at oral prednisolone induced medical nasal polypectomy followed by maintenance on topical steroid therapy in patients with nasal poly...
Eligibility Criteria
Inclusion
- male or female
- 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
- unilateral nasal polyposis
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00788749
Start Date
May 1 2004
End Date
November 1 2008
Last Update
November 11 2008
Active Locations (1)
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1
Ninewells Hospital and Medical School
Dundee, Angus, United Kingdom, DD1 9SY