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

NCT04532736 | Completed Phase 2

• 1 other identifier: 216S871
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasal Polyposis

Keywords

Nasal polyposis; chronic rhinosinusitis; methotrexate; methylprednisolone; phase 2 clinical trial; mometasone furoate

Outcome Measures

Primary Outcomes (1)

• Lund-Kennedy endoscopic grading system (NPS)

  Occurrence of polyps, edema, discharge, scar and crusting parameters were scored according to the 0-1-2 rating system.

  Change from baseline NPS at 4th and 8th weeks visits

Secondary Outcomes (6)

• Total visual analog scale (VAS)

  Change from baseline VAS at 4th and 8th weeks visits

• Sinonasal Outcome Test-22 (SNOT-22)

  Change from baseline SNOT-22 at 4th and 8th visits

• Peak nasal inspiratory flow (PNIF)

  Change from baseline PNIF at 4th and 8th visits

• Butanol olfactory threshold test (BuOT)

  Change from baseline BuOT at 4th and 8th visits

• Total immunoglobulin E (IgE) level

  Change from baseline total IgE level at 4th and 8th visits

Study Arms (3)

Methotrexate

EXPERIMENTAL

10 mg Emthexate, PO, once a week during 8 weeks

Drug: Emthexate

Methylprednisolone

ACTIVE COMPARATOR

8 mg/day Prednol, PO, for 8 weeks

Drug: Prednol

Control

ACTIVE COMPARATOR

200 mcg/day, intranasal mometasone furoate, for 8 weeks

Drug: Mometasone Furoate

Interventions

Emthexate DRUG

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)

Also known as: Methotrexate

Methotrexate

Prednol DRUG

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)

Also known as: Methylprednisolone

Methylprednisolone

Mometasone Furoate DRUG

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)

Also known as: Corticosteroid

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• years of age from both sexes,
• Signed an informed consent form,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Dokuz Eylul University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Dokuz Eylul University School of Medicine

Izmir, General, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nasal Polyps

Interventions

Methotrexate; Methylprednisolone; Mometasone Furoate; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Yesim Tuncok, MD

  Dokuz Eylul University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacologist

Model Details: A Randomized, Controlled, Triple Armed, Parallel, Open-label Phase 2 Clinical Trial

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: August 31, 2020
• Study Start: September 2, 2017
• Primary Completion: March 12, 2019
• Study Completion: May 5, 2019
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)