Medical Polypectomy and Predictors of Response

November 10, 2008 updated by: University of Dundee

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Angus
      • Dundee, Angus, United Kingdom, DD1 9SY
        • Ninewells Hospital and Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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
Other: fluticasone nasal drops
fluticasone nasal drops 800mcg/d
Other: fluticasone nasal spray
fluticasone nasal spray 400 mcg/d
Drug: Prednisolone
tablets 25 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endoscopy Polyp Grading
Time Frame: 0, 2 weeks, 10 weeks, 28 weeks
0, 2 weeks, 10 weeks, 28 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Mini RQLQ
Time Frame: 0, 2 wks, 10 wks, 28 wks
0, 2 wks, 10 wks, 28 wks
TNS-4
Time Frame: 0, 2 wks, 10 wks, 28 wks
0, 2 wks, 10 wks, 28 wks
PNIF
Time Frame: 0,2 wks, 10 wks,28 wks
0,2 wks, 10 wks,28 wks
Anosmia score
Time Frame: 0, 2 wks, 10 wks, 28 wks
0, 2 wks, 10 wks, 28 wks
Scratch n Sniff cards
Time Frame: 0, 2 wks, 10 wks, 28 wks
0, 2 wks, 10 wks, 28 wks
OUCC
Time Frame: 0, 2 wks, 10 wks, 28 wks
0, 2 wks, 10 wks, 28 wks
1 mcg Synacthen test
Time Frame: 0, 2 wks, 10 wks, 28 wks
0, 2 wks, 10 wks, 28 wks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Collaborators

NHS Tayside
Chief Scientist Office of the Scottish Government

Investigators

  • Study Director: Brian J Lipworth, MD, University of Dundee
  • Principal Investigator: Sriram Vaidyanathan, MRCS, University of Dundee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (Estimate)

November 11, 2008

Study Record Updates

Last Update Posted (Estimate)

November 11, 2008

Last Update Submitted That Met QC Criteria

November 10, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRAY07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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