Clinical Trial: Medical Polypectomy and Predictors of Response
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Proof Of Concept Study to Investigate the Clinical, Histological And Molecular Predictors of Response to Oral and Intranasal Corticosteroid in Nasal Polyposis
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 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.
Detailed Summary:
Sponsor: University of Dundee
Current Primary Outcome: Endoscopy Polyp Grading [ Time Frame: 0, 2 weeks, 10 weeks, 28 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Mini RQLQ [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
- TNS-4 [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
- PNIF [ Time Frame: 0,2 wks, 10 wks,28 wks ]
- Anosmia score [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
- Scratch n Sniff cards [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
- OUCC [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
- 1 mcg Synacthen test [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
Original Secondary Outcome: Same as current
Information By: University of Dundee
Dates:
Date Received: November 7, 2008
Date Started: May 2004
Date Completion:
Last Updated: November 10, 2008
Last Verified: November 2008
