NCT00788749

Medical Polypectomy and Predictors of Response

A Proof Of Concept Study to Investigate the Clinical, Histological And Molecular Predictors of Response to Oral and Intranasal Corticosteroid in Nasal Polyposis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Dundee · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasal Polyps

Interventions

Type	Name	Description
DRUG	Prednisolone	tablets 25 mg/day
DRUG	Placebo	tablets once daily
OTHER	fluticasone nasal drops	fluticasone nasal drops 800mcg/d
OTHER	fluticasone nasal spray	fluticasone nasal spray 400 mcg/d

Timeline

• Start date: 2004-05-01
• Primary completion: 2008-02-01
• Completion: 2008-11-01
• First posted: 2008-11-11
• Last updated: 2008-11-11

Locations

1 site across 1 country: United Kingdom