NCT00480298

Double-Blind Randomized Placebo-Controlled Trial on Clinical and Biological Effects of Oral Corticosteroids or Doxycyclin in Patients With Nasal Polyposis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (planned)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a double-blinded, randomized, placebo controlled, multi-center trial in which 120 subjects with nasal polyposis (NP) will be treated during 20 days with oral corticosteroids (OCS) in decreasing doses or oral doxycyclin (ODOX) or placebo. At each visit the clinical and the biological activity will be assessed by nasal peak inspiratory flow (nPIF), symptoms, olfactory test, endoscopic evaluation of nasal polyps, peripheral eosinophil levels and markers of inflammation IL-5, IL-5 receptor alpha, ECP, TGFβ1, IgE and specific IgE in serum and nasal secretion.

Conditions

• Nasal Polyposis

Interventions

Type	Name	Description
DRUG	Administration of oral methylprednisolone

Timeline

• Start date: 2002-11-01
• Completion: 2006-07-01
• First posted: 2007-05-30
• Last updated: 2007-12-28

Locations

1 site across 1 country: Belgium