A Phase 4 interventional study of Prednisolone and Placebo in Nasal Polyps, sponsored by University of Dundee. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-11-11.
Sponsored by University of Dundee · Phase 4, Interventional, and Treatment
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.
214 studies on the registry are indexed under Nasal Polyps; 51 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 163 interventional studies indexed under Nasal Polyps.
Browse Nasal Polyps studies →University of Dundee is the lead sponsor of 111 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Placebo · Other: fluticasone nasal drops · Other: fluticasone nasal spray
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
Drug: Prednisolone · Other: fluticasone nasal drops · Other: fluticasone nasal spray
tablets 25 mg/day
tablets once daily
fluticasone nasal drops 800mcg/d
fluticasone nasal spray 400 mcg/d
Endoscopy Polyp Grading
Time frame: 0, 2 weeks, 10 weeks, 28 weeks
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
This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.
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University of Dundee