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| Name | Class |
|---|---|
| Chief Scientist Office of the Scottish Government | OTHER_GOV |
| NHS Tayside | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | tablets 25 mg/day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopy Polyp Grading | 0, 2 weeks, 10 weeks, 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mini RQLQ | 0, 2 wks, 10 wks, 28 wks | |
| TNS-4 | 0, 2 wks, 10 wks, 28 wks | |
| PNIF |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sriram Vaidyanathan, MRCS | University of Dundee | Principal Investigator |
| Brian J Lipworth, MD | University of Dundee | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ninewells Hospital and Medical School | Dundee | Angus | DD1 9SY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21676042 | Derived | Williamson PA, Vaidyanathan S, Clearie K, Barnes M, Lipworth BJ. Airway dysfunction in nasal polyposis: a spectrum of asthmatic disease? Clin Exp Allergy. 2011 Oct;41(10):1379-85. doi: 10.1111/j.1365-2222.2011.03793.x. Epub 2011 Jun 16. | |
| 21357906 | Derived | Vaidyanathan S, Barnes M, Williamson P, Hopkinson P, Donnan PT, Lipworth B. Treatment of chronic rhinosinusitis with nasal polyposis with oral steroids followed by topical steroids: a randomized trial. Ann Intern Med. 2011 Mar 1;154(5):293-302. doi: 10.7326/0003-4819-154-5-201103010-00003. |
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| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
tablets once daily |
|
| fluticasone nasal drops | Other | fluticasone nasal drops 800mcg/d |
|
| fluticasone nasal spray | Other | fluticasone nasal spray 400 mcg/d |
|
| 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 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |