Medical Polypectomy and Predictors of Response

Nasal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00788749
• Other study ID #: GRAY07
• Status: Completed
• Phase: Phase 4
• First received: November 7, 2008
• Last updated: November 10, 2008
• Start date: May 2004
• Est. completion date: November 2008

Study information

• Verified date: November 2008
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasal Polyps

Intervention

Drug:
• Prednisolone
tablets 25 mg/day
• Placebo
tablets once daily

Other:
• fluticasone nasal drops
fluticasone nasal drops 800mcg/d
• fluticasone nasal spray
fluticasone nasal spray 400 mcg/d

Locations

Country	Name	City	State
United Kingdom	Ninewells Hospital and Medical School	Dundee	Angus

Sponsors (3)

Lead Sponsor	Collaborator
University of Dundee	Chief Scientist Office of the Scottish Government, NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopy Polyp Grading		0, 2 weeks, 10 weeks, 28 weeks	No
Secondary	Mini RQLQ		0, 2 wks, 10 wks, 28 wks	No
Secondary	TNS-4		0, 2 wks, 10 wks, 28 wks	No
Secondary	PNIF		0,2 wks, 10 wks,28 wks	No
Secondary	Anosmia score		0, 2 wks, 10 wks, 28 wks	No
Secondary	Scratch n Sniff cards		0, 2 wks, 10 wks, 28 wks	No
Secondary	OUCC		0, 2 wks, 10 wks, 28 wks	Yes
Secondary	1 mcg Synacthen test		0, 2 wks, 10 wks, 28 wks	Yes