Nasal Polyps
Conditions
Keywords
chronic rhinosinusitis, nasal polyps, oral steroid, intranasal steroid, medical polypectomy
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.
Interventions
DRUGPrednisolone
tablets 25 mg/day
DRUGPlacebo
tablets once daily
OTHERfluticasone nasal drops
fluticasone nasal drops 800mcg/d
fluticasone nasal spray 400 mcg/d
Sponsors
Chief Scientist Office of the Scottish Government
NHS Tayside
University of Dundee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endoscopy Polyp Grading | 0, 2 weeks, 10 weeks, 28 weeks |
Secondary
| Measure | Time frame |
|---|---|
| TNS-4 | 0, 2 wks, 10 wks, 28 wks |
| PNIF | 0,2 wks, 10 wks,28 wks |
| Anosmia score | 0, 2 wks, 10 wks, 28 wks |
| Mini RQLQ | 0, 2 wks, 10 wks, 28 wks |
| OUCC | 0, 2 wks, 10 wks, 28 wks |
| 1 mcg Synacthen test | 0, 2 wks, 10 wks, 28 wks |
| Scratch n Sniff cards | 0, 2 wks, 10 wks, 28 wks |
Countries
United Kingdom
Outcome results
None listed