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| Sponsor: | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00480298 History of Changes |
| Other Study ID Numbers: | 2002/067 |
| Study First Received: | May 25, 2007 |
| Last Updated: | December 19, 2007 |
| Health Authority: | Belgium: Institutional Review Board |
|
Nasal Polyps Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Polyps Pathological Conditions, Anatomical Methylprednisolone acetate Prednisolone acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Prednisolone phosphate Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents |