Medical Polypectomy and Predictors of Response

University of Dundee

Status and phase: Completed; Phase 4

Conditions: Nasal Polyps

Treatments: Drug: Placebo; Other: fluticasone nasal spray; Drug: Prednisolone; Other: fluticasone nasal drops

Study type: Interventional

Funder types: Other

Identifiers

NCT00788749

GRAY07

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Other: fluticasone nasal drops

Other: fluticasone nasal spray

Prednisolone

Experimental group

Description:

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

Treatment:

Other: fluticasone nasal drops

Drug: Prednisolone

Other: fluticasone nasal spray