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
Verified date | August 2020 |
Source | Dokuz Eylul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | May 5, 2019 |
Est. primary completion date | March 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
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, |
Country | Name | City | State |
---|---|---|---|
Turkey | Dokuz Eylul University School of Medicine | Izmir | General |
Lead Sponsor | Collaborator |
---|---|
Dokuz Eylul University | The Scientific and Technological Research Council of Turkey |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Total visual analog scale (VAS) | Smell, nasal discharge, nasal obstruction, facial pressure, and headache were scored between 0 (no complaint) and 10 (most annoying) | Change from baseline VAS at 4th and 8th weeks visits | |
Secondary | Sinonasal Outcome Test-22 (SNOT-22) | Change in the 22-item symptom questionnaire scale used to evaluate the presence of symptoms of chronic rhinosinusitis and their effect on quality of life | Change from baseline SNOT-22 at 4th and 8th visits | |
Secondary | Peak nasal inspiratory flow (PNIF) | During inspiration, nasal peak airflows were detected with the nasal mask attached to the Clement-Clark peak flow-meter. Right and left nostrils of each patient were evaluated separately. | Change from baseline PNIF at 4th and 8th visits | |
Secondary | Butanol olfactory threshold test (BuOT) | The odor thresholds of the patients who smelled the bottle containing 9 different concentrations of butanol between 0.00061 and 4% were determined. | Change from baseline BuOT at 4th and 8th visits | |
Secondary | Total immunoglobulin E (IgE) level | To detect serum IgE level in the blood IgE level measured in peripheral blood | Change from baseline total IgE level at 4th and 8th visits | |
Secondary | Presence of peripheral eosinophilia (PE, > 500/mcl) in blood samples | Detection of eosinophil count> 500 / mcl in blood samples | Change from baseline presence of peripheral eosinophilia at 4th and 8th visits |
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