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Medical Polypectomy and Predictors of Response

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ClinicalTrials.gov Identifier: NCT00788749
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : November 11, 2008
Sponsor:
Collaborators:
Information provided by:

November 7, 2008
November 11, 2008
November 11, 2008
May 2004
February 2008   (Final data collection date for primary outcome measure)
Endoscopy Polyp Grading [ Time Frame: 0, 2 weeks, 10 weeks, 28 weeks ]
Same as current
No Changes Posted
  • Mini RQLQ [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
  • TNS-4 [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
  • PNIF [ Time Frame: 0,2 wks, 10 wks,28 wks ]
  • Anosmia score [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
  • Scratch n Sniff cards [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
  • OUCC [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
  • 1 mcg Synacthen test [ Time Frame: 0, 2 wks, 10 wks, 28 wks ]
Same as current
Not Provided
Not Provided
 
Medical Polypectomy and Predictors of Response
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Nasal Polyps
  • 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
  • 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
    Interventions:
    • Drug: Placebo
    • Other: fluticasone nasal drops
    • Other: fluticasone nasal spray
  • 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
    Interventions:
    • Drug: Prednisolone
    • Other: fluticasone nasal drops
    • Other: fluticasone nasal spray

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2008
February 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00788749
GRAY07
No
Not Provided
Not Provided
Sriram Vaidyanathan, University of Dundee
University of Dundee
  • Chief Scientist Office of the Scottish Government
  • NHS Tayside
Principal Investigator: Sriram Vaidyanathan, MRCS University of Dundee
Study Director: Brian J Lipworth, MD University of Dundee
University of Dundee
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP