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Sponsored by: |
University Hospital, Ghent |
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Information provided by: | University Hospital, Ghent |
ClinicalTrials.gov Identifier: | NCT00480298 |
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 |
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Nasal Polyposis |
Drug: Administration of oral methylprednisolone |
Phase II |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 2002/067 |
Study First Received: | May 25, 2007 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00480298 History of Changes |
Health Authority: | Belgium: Institutional Review Board |
Pathological Conditions, Anatomical Anti-Inflammatory Agents Otorhinolaryngologic Diseases Antineoplastic Agents, Hormonal Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Methylprednisolone acetate Antiemetics |
Polyps Prednisolone acetate Hormones Glucocorticoids Neuroprotective Agents Nasal Polyps Prednisolone Peripheral Nervous System Agents Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Pathological Conditions, Anatomical Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Polyps Neuroprotective Agents Hormones Nasal Polyps Therapeutic Uses |
Methylprednisolone Hemisuccinate Otorhinolaryngologic Diseases Antineoplastic Agents, Hormonal Gastrointestinal Agents Methylprednisolone acetate Protective Agents Glucocorticoids Pharmacologic Actions Nose Diseases Autonomic Agents Prednisolone Peripheral Nervous System Agents Central Nervous System Agents |