Clinical trial NCT00788749: Medical Polypectomy and Predictors of Response
Official title: A Proof Of Concept Study to Investigate the Clinical, Histological And Molecular Predictors of Response to Oral and Intranasal Corticosteroid in Nasal Polyposis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasal Polyps
Keywords: chronic rhinosinusitis
nasal polyps
oral steroid
intranasal steroid
medical polypectomy
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: Chief Scientist Office of the Scottish Government
name: NHS Tayside
First posted: 2008-11-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Endoscopy Polyp Grading
timeFrame: 0, 2 weeks, 10 weeks, 28 weeks
Secondary outcomes:
measure: Mini RQLQ
timeFrame: 0, 2 wks, 10 wks, 28 wks
measure: TNS-4
timeFrame: 0, 2 wks, 10 wks, 28 wks
measure: PNIF
timeFrame: 0,2 wks, 10 wks,28 wks
measure: Anosmia score
timeFrame: 0, 2 wks, 10 wks, 28 wks
measure: Scratch n Sniff cards
timeFrame: 0, 2 wks, 10 wks, 28 wks
measure: OUCC
timeFrame: 0, 2 wks, 10 wks, 28 wks
measure: 1 mcg Synacthen test
timeFrame: 0, 2 wks, 10 wks, 28 wks
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Angus
Study officials:
affiliation: University of Dundee
name: Sriram Vaidyanathan, MRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dundee
name: Brian J Lipworth, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.