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Medical Polypectomy and Predictors of Response

NCT00788749 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2008-11-11

No results posted yet for this study

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.

Conditions

  • Nasal Polyps

Interventions

DRUG

Prednisolone

tablets 25 mg/day

DRUG

Placebo

tablets once daily

OTHER

fluticasone nasal drops

fluticasone nasal drops 800mcg/d

OTHER

fluticasone nasal spray

fluticasone nasal spray 400 mcg/d

Sponsors & Collaborators

  • Chief Scientist Office of the Scottish Government

    collaborator OTHER_GOV

  • NHS Tayside

    collaborator OTHER_GOV

  • University of Dundee

    lead OTHER

Principal Investigators

  • Sriram Vaidyanathan, MRCS · University of Dundee

  • Brian J Lipworth, MD · University of Dundee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2008-02-29
Completion
2008-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00788749 on ClinicalTrials.gov