Comparison of Methylprednisolone or Methotrexate in the Maintenance Treatment of Nasal Polyposis
Condition: Nasal Polyposis
MeSH terms: Colorectal Neoplasms; Nasopharyngeal Neoplasms; Nasal Polyps
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Methotrexate, as an anti-inflammatory drug used in animal experiments, and low dose systemic
      corticosteroid treatments have recently been suggested for the treatment of the CRwNP.
      Despite the several case reports of methotrexate being used for the severe and
      treatment-resistant CRwNP, the literature is a lack of clinical trials. Likewise, low-dose
      corticosteroid regimens have not been tested well contrary to the high dose corticosteroid
      therapy in the same course of the disease. Therefore, the main purpose of this study is to
      compare a low-dose of methylprednisolone or a low dose of methotrexate treatments with the
      standard intranasal, topical corticosteroid treatment in human volunteers with medical and
      surgical treatment-resistant CRwNP.

      The present study was planned as a randomized, controlled, triple armed, parallel, open-label
      phase 2 clinical trial which is conducted in the Department of Otorhinolaryngology at Dokuz
      Eylül University Hospital. Human volunteers with CRwNP who are resistant to the medical and
      surgical therapies were recruited to the study. After randomization, the patients were
      divided into three groups including 14 volunteers in each study groups and 13 in the control
      group. One of the study groups was take methotrexate (n=14, eight weeks) and the other was
      take methylprednisolone (n=14, eight weeks). Each patient were evaluated by endoscopic
      examination, the nasal air-flow, the smell threshold, and the blood biochemistry both before
      and after the medications.

      Efficacy goals of the study are located at below:

        1. Primary efficacy variable: Lund-Kennedy endoscopic grading system (NPS)

        2. Secondary efficacy variables: Total visual analog scale (VAS) score; the Turkish version
           of the Sinonasal Outcome Test-22 (SNOT-22); sum score of the peak nasal inspiratory flow
           (PNIF) and butanol olfactory threshold test (BuOT) obtained from bilateral nasal
           cavities; serum total immunoglobulin E (IgE) level; and the presence of peripheral
           eosinophilia (PE, > 500/mcl) in blood samples.

      Safety goal of the study was evaluated by the examination of the adverse event reports and
      the number of patients who experienced adverse events.

      Statistical analysis: The normality of the continuous variables was evaluated by the Shapiro
      Wilk test. Comparison of age was performed using one-way analysis of variance (ANOVA).
      Repeated measurements in three groups were analyzed using repeated measures ANOVA for 3×3
      model with a within and a between-subjects factor. The results were assessed with a 95%
      confidence interval and at the p<0.05 significance level.
    

Intervention name(s): Emthexate; Prednol; Mometasone Furoate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): After randomization, the patients were divided into three groups including 14 volunteers in each study groups and 11 in the control group. One of the study groups was take methotrexate (n=14, eight weeks) and the other was take methylprednisolone (n=14, eight week); After randomization, the patients were divided into three groups including 14 volunteers in each study groups and 11 in the control group. One of the study groups was take methotrexate (n=14, eight weeks) and the other was take methylprednisolone (n=14, eight week); After randomization, the patients were divided into three groups including 14 volunteers in each study groups and 11 in the control group. One of the study groups was take methotrexate (n=14, eight weeks) and the other was take methylprednisolone (n=14, eight week)
Other intervention name(s): Methotrexate; Methylprednisolone; Corticosteroid
Intervention MeSH terms: Mometasone Furoate; Methylprednisolone; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized, Controlled, Triple Armed, Parallel, Open-label Phase 2 Clinical Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nasal polyposis; chronic rhinosinusitis; methotrexate; methylprednisolone; phase 2 clinical trial; mometasone furoate