Medical Polypectomy and Predictors of Response

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

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 polyposis. This study also looks at the effect of aspirin sensitivity and the factors linking nasal polyps with asthma. We have also taken baseline measurements of a variety of blood, surface and biopsy markers to assess for potential to predict steroid response. Finally, the still unchartered link between nasal polyps and asthma will be explored by measuring Staphylococcal superantigens in serum before and after treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Dundee
• Collaborators: Chief Scientist Office of the Scottish Government; NHS Tayside
• Treatments: Fluticasone; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Xhance

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.