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Medical Polypectomy and Predictors of Response

Primary Purpose

Nasal Polyps

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Prednisolone
Placebo
fluticasone nasal drops
fluticasone nasal spray
Sponsored by
University of Dundee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Polyps focused on measuring chronic rhinosinusitis, nasal polyps, oral steroid, intranasal steroid, medical polypectomy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ninewells Hospital and Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Prednisolone

Arm Description

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

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

Outcomes

Primary Outcome Measures

Endoscopy Polyp Grading

Secondary Outcome Measures

Mini RQLQ
TNS-4
PNIF
Anosmia score
Scratch n Sniff cards
OUCC
1 mcg Synacthen test

Full Information

First Posted
November 7, 2008
Last Updated
November 10, 2008
Sponsor
University of Dundee
Collaborators
Chief Scientist Office of the Scottish Government, NHS Tayside
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1. Study Identification

Unique Protocol Identification Number
NCT00788749
Brief Title
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

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Dundee
Collaborators
Chief Scientist Office of the Scottish Government, NHS Tayside

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Polyps
Keywords
chronic rhinosinusitis, nasal polyps, oral steroid, intranasal steroid, medical polypectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Prednisolone
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
tablets 25 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablets once daily
Intervention Type
Other
Intervention Name(s)
fluticasone nasal drops
Intervention Description
fluticasone nasal drops 800mcg/d
Intervention Type
Other
Intervention Name(s)
fluticasone nasal spray
Intervention Description
fluticasone nasal spray 400 mcg/d
Primary Outcome Measure Information:
Title
Endoscopy Polyp Grading
Time Frame
0, 2 weeks, 10 weeks, 28 weeks
Secondary Outcome Measure Information:
Title
Mini RQLQ
Time Frame
0, 2 wks, 10 wks, 28 wks
Title
TNS-4
Time Frame
0, 2 wks, 10 wks, 28 wks
Title
PNIF
Time Frame
0,2 wks, 10 wks,28 wks
Title
Anosmia score
Time Frame
0, 2 wks, 10 wks, 28 wks
Title
Scratch n Sniff cards
Time Frame
0, 2 wks, 10 wks, 28 wks
Title
OUCC
Time Frame
0, 2 wks, 10 wks, 28 wks
Title
1 mcg Synacthen test
Time Frame
0, 2 wks, 10 wks, 28 wks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sriram Vaidyanathan, MRCS
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian J Lipworth, MD
Organizational Affiliation
University of Dundee
Official's Role
Study Director
Facility Information:
Facility Name
Ninewells Hospital and Medical School
City
Dundee
State/Province
Angus
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21676042
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.
Results Reference
derived
PubMed Identifier
21357906
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.
Results Reference
derived

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Medical Polypectomy and Predictors of Response

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