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Completed

NCT Number: NCT00788749

Medical Polypectomy and Predictors of Response

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.

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Key information

Conditions

Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ninewells Hospital and Medical School

Dundee, Angus, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prednisolone

Drug

tablets 25 mg/day

Placebo

Drug

tablets once daily

fluticasone nasal drops

Other

fluticasone nasal drops 800mcg/d

fluticasone nasal spray

Other

fluticasone nasal spray 400 mcg/d

Primary outcomes

  1. Endoscopy Polyp Grading

    Time frame: 0, 2 weeks, 10 weeks, 28 weeks

Secondary outcomes

  1. Mini RQLQ

    Time frame: 0, 2 wks, 10 wks, 28 wks

  2. TNS-4

    Time frame: 0, 2 wks, 10 wks, 28 wks

  3. PNIF

    Time frame: 0,2 wks, 10 wks,28 wks

  4. Anosmia score

    Time frame: 0, 2 wks, 10 wks, 28 wks

  5. Scratch n Sniff cards

    Time frame: 0, 2 wks, 10 wks, 28 wks

  6. OUCC

    Time frame: 0, 2 wks, 10 wks, 28 wks

  7. 1 mcg Synacthen test

    Time frame: 0, 2 wks, 10 wks, 28 wks

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • Chief Scientist Office of the Scottish Government
  • NHS Tayside

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Nov 11, 2008
Registry last updated
Nov 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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