Trial | NCT00788749  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    fluticasone prednisone ...

  • Study Participants

    60
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 Started
May 31
2004
Primary Completion
Feb 29
2008
Study Completion
Nov 30
2008
Last Update
Nov 11
2008
Estimate

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 Placebo Comparator

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

Prednisolone Experimental

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

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.
No Results Posted