Comparison of Methylprednisolone or Methotrexate in the Maintenance Treatment of Nasal Polyposis
Status:
Completed
Trial end date:
2019-05-05
Target enrollment:
Participant gender:
Summary
Chronic rhinosinusitis with nasal polyposis (CRwNP) is an inflammatory disease of the nasal
mucosa. It is presented with severe stuffiness, nasal discharge, facial pressure/pain, and
sleep disorders. It leads to severe inconvenience to social life and the quality of life. The
first step standard medical therapy consists of the topical intranasal or systemic
corticosteroids. Surgery should be considered in the case of medical treatment failure.
However, the recurrences are common after both surgery and medical therapies in severe
disease and usually require revision surgeries or high dose corticosteroid regimens. On the
contrary, either the revision surgeries or the high dose corticosteroid therapies are not
capable of preventing the recurrences, treatment failures. Besides, revision surgeries
usually lead to high complication rates and high dose corticosteroids usually cause severe
adverse effects. The use of the short course topical intranasal corticosteroids after the
surgery is generally advocated for these patients. However, the recurrence rates are still
high. Hence a new and effective maintenance treatment algorithm with no severe adverse
effects is required.
The hypothesis of the clinical trial is an estimated symptom recovery and superiority in both
efficacy and safety by the use of low-dose methylprednisolone or methotrexate as compared to
the standard maintenance therapy in treatment-resistant CRwNP patients. Therefore, the
results of the present study are believed to provide data on novel maintenance therapy and
suggest an alternative to the topical intranasal corticosteroids or the high-risk revision
surgery.
Phase:
Phase 2
Details
Lead Sponsor:
Dokuz Eylul University
Collaborator:
The Scientific and Technological Research Council of Turkey