Comparison of Methylprednisolone or Methotrexate in the Maintenance Treatment of Nasal Polyposis

• Status: Completed
• Trial end date: 2019-05-05
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dokuz Eylul University
• Collaborator: The Scientific and Technological Research Council of Turkey
• Treatments: Methotrexate; Methylprednisolone; Mometasone Furoate

Criteria

Inclusion Criteria:

• The diagnosis of chronic rhinosinusitis with nasal polyposis (CRS) with nasal polyposis which does not respond to maintenance treatment with topical nasal corticosteroid treatment after medical and surgical treatment,

• 18-75 years of age from both sexes,

• Signed an informed consent form,

Exclusion Criteria:

• Systemic oral methylprednisolone or systemic oral methotrexate treatment for another reason,

• Has a known malignant disease,

• Have contraindications or allergies to the use of excipients in oral methotrexate or preparations,

• Contraindications or allergies in the use of oral methylprednisolone or excipients contained in the preparation,

• Have contraindications or allergies to the use of excipients contained in nasal topical mometasone furoate or its preparation,

• Pregnancy status,

• Having a pregnancy plan,