Medical Polypectomy and Predictors of Response

Sponsor

University of Dundee (Other)

Overall Status

Completed

CT.gov ID

NCT00788749

Collaborator

Chief Scientist Office of the Scottish Government (Other), NHS Tayside (Other)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nasal Polyps	Drug: Prednisolone Drug: Placebo Other: fluticasone nasal drops Other: fluticasone nasal spray	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2004

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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	Drug: Placebo tablets once daily Other: fluticasone nasal drops fluticasone nasal drops 800mcg/d Other: fluticasone nasal spray fluticasone nasal spray 400 mcg/d
Experimental: 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	Drug: Prednisolone tablets 25 mg/day Other: fluticasone nasal drops fluticasone nasal drops 800mcg/d Other: fluticasone nasal spray fluticasone nasal spray 400 mcg/d

Arm

Intervention/Treatment

Placebo Comparator: 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

Drug: Placebo

tablets once daily

Other: fluticasone nasal drops

fluticasone nasal drops 800mcg/d

Other: fluticasone nasal spray

fluticasone nasal spray 400 mcg/d

Experimental: 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

Drug: Prednisolone

tablets 25 mg/day

Other: fluticasone nasal drops

fluticasone nasal drops 800mcg/d

Other: fluticasone nasal spray

fluticasone nasal spray 400 mcg/d

Outcome Measures

Primary Outcome Measures

Endoscopy Polyp Grading [0, 2 weeks, 10 weeks, 28 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.