Medical Polypectomy and Predictors of Response
Phase 4
Completed
- Conditions
- Nasal Polyps
- Interventions
- Registration Number
- NCT00788749
- Lead Sponsor
- University of Dundee
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 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 Placebo fluticasone nasal drops 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 Placebo fluticasone nasal spray 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 Prednisolone Prednisolone 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 Prednisolone fluticasone nasal drops 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 Prednisolone 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
- Primary Outcome Measures
Name Time Method Endoscopy Polyp Grading 0, 2 weeks, 10 weeks, 28 weeks
- Secondary Outcome Measures
Name Time Method Mini RQLQ 0, 2 wks, 10 wks, 28 wks 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 Scratch n Sniff cards 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
Trial Locations
- Locations (1)
Ninewells Hospital and Medical School
🇬🇧Dundee, Angus, United Kingdom