Nasal Polyposis Clinical Trial
Official title:
Comparison of Methylprednisolone or Methotrexate With Standard Treatment in the Maintenance Treatment of Medically and Surgically Treated Chronic Rhinosinusitis With Nasal Polyposis
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.
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.
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