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| Sponsored by: |
University Hospital, Ghent |
| Information provided by: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT00480298 |
Purpose
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.
| Condition | Intervention | Phase |
|
Nasal Polyposis |
Drug: Administration of oral methylprednisolone |
Phase II |
| MedlinePlus related topics: | Endoscopy |
| ChemIDplus related topics: | Methylprednisolone Corticosteroids Salicylsalicylic acid Sodium salicylate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | Double-Blind Randomized Placebo-Controlled Trial on Clinical and Biological Effects of Oral Corticosteroids or Doxycyclin in Patients With Nasal Polyposis |
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2002 |
| Study Completion Date: | July 2006 |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
University Hospital Ghent 
  |
| Study ID Numbers: | 2002/067 |
| First Received: | May 25, 2007 |
| Last Updated: | December 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00480298 |
| Health Authority: | Belgium: Institutional Review Board |
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