Medical Polypectomy and Predictors of Response

Study Overview
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Brief Summary
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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.

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

Conditions
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Nasal Polyps

Intervention / Treatment
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* Drug: Prednisolone
* Drug: Placebo
* Other: fluticasone nasal drops
* Other: fluticasone nasal spray


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* tablets once daily<br>Other: fluticasone nasal drops<br>* fluticasone nasal drops 800mcg/d<br>Other: fluticasone nasal spray<br>* fluticasone nasal spray 400 mcg/d<br>|
| Experimental: Prednisolone<br>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<br>* tablets 25 mg/day<br>Other: fluticasone nasal drops<br>* fluticasone nasal drops 800mcg/d<br>Other: fluticasone nasal spray<br>* fluticasone nasal spray 400 mcg/d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopy Polyp Grading |  | 0, 2 weeks, 10 weeks, 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic rhinosinusitis, nasal polyps, oral steroid, intranasal steroid, medical polypectomy