Nasal PolyposisPhase 2NCT04532736
Comparison of Methylprednisolone or Methotrexate in the Maintenance Treatment of Nasal Polyposis
A Phase 2 study testing Emthexate, Prednol and Mometasone Furoate in people with Nasal Polyposis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasal Polyposis
- What is being tested?
- Emthexate, Prednol and Mometasone Furoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2017to 5 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University School of Medicine
Izmir, General, 35340
About this study
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.
Read the 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:
- Primary efficacy variable: Lund-Kennedy endoscopic grading system (NPS)
- 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.
- Conditions
- Nasal Polyposis
- Being tested
- Emthexate, Prednol, Mometasone Furoate
- Keywords
- Nasal polyposis, chronic rhinosinusitis, methotrexate, methylprednisolone, phase 2 clinical trial, mometasone furoate
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmthexateDrug
Also called Methotrexate
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)
PrednolDrug
Also called Methylprednisolone
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)
Mometasone FuroateDrug
Also called Corticosteroid
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)
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate | Experimental | 10 mg Emthexate, PO, once a week during 8 weeks Receives: Drug: Emthexate |
| Methylprednisolone | Active comparator | 8 mg/day Prednol, PO, for 8 weeks Receives: Drug: Prednol |
| Control | Active comparator | 200 mcg/day, intranasal mometasone furoate, for 8 weeks Receives: Drug: Mometasone Furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline NPS at 4th and 8th weeks visits
Secondary outcomes (6)
Total visual analog scale (VAS)
Smell, nasal discharge, nasal obstruction, facial pressure, and headache were scored between 0 (no complaint) and 10 (most annoying)
Measured: Change from baseline VAS at 4th and 8th weeks visits
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
Measured: Change from baseline SNOT-22 at 4th and 8th visits
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.
Measured: Change from baseline PNIF at 4th and 8th visits
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.
Measured: Change from baseline BuOT at 4th and 8th visits
Total immunoglobulin E (IgE) level
To detect serum IgE level in the blood IgE level measured in peripheral blood
Measured: Change from baseline total IgE level at 4th and 8th visits
Presence of peripheral eosinophilia (PE, > 500/mcl) in blood samples
Detection of eosinophil count> 500 / mcl in blood samples
Measured: Change from baseline presence of peripheral eosinophilia at 4th and 8th visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start2 Sep 2017
- Primary completion12 Mar 2019
- Study completion5 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolyposisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Controlled, Triple Armed, Parallel, Open-label Phase 2 Clinical Trial
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Yesim Tuncok, Dokuz Eylul University
- Investigators
- Yesim Tuncok, MD, Principal investigator, Dokuz Eylul University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532736
- Sponsor's protocol ID
- 216S871
- Status last verified
- Aug 2020
- First submitted
- 15 Jan 2019
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methylprednisolone or Methotrexate With Standard Treatment in the Maintenance Treatment of Medically and Surgically Treated Chronic Rhinosinusitis With Nasal Polyposis
- ClinicalTrials.gov ID
- NCT04532736
- Acronym / sponsor ID
- 216S871
- Conditions
- Nasal Polyposis
- Keywords
- Nasal polyposis, chronic rhinosinusitis, methotrexate, methylprednisolone, phase 2 clinical trial, mometasone furoate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 2 Sep 2017 (actual)
- Primary completion
- 12 Mar 2019 (actual)
- Study completion
- 5 May 2019 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Primary efficacy variable: Lund-Kennedy endoscopic grading system (NPS)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A Randomized, Controlled, Triple Armed, Parallel, Open-label Phase 2 Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Methotrexate | Experimental | Drug: Emthexate10 mg Emthexate, PO, once a week during 8 weeks |
| Methylprednisolone | Active comparator | Drug: Prednol8 mg/day Prednol, PO, for 8 weeks |
| Control | Active comparator | Drug: Mometasone Furoate200 mcg/day, intranasal mometasone furoate, for 8 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EmthexateAlso: MethotrexateAfter 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) | Drug | Methotrexate |
| PrednolAlso: MethylprednisoloneAfter 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) | Drug | Methylprednisolone |
| Mometasone FuroateAlso: CorticosteroidAfter 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) | Drug | Control |
Primary outcome
Lund-Kennedy endoscopic grading system (NPS)
Time frame: Change from baseline NPS at 4th and 8th weeks visits
Occurrence of polyps, edema, discharge, scar and crusting parameters were scored according to the 0-1-2 rating system.
6 secondary outcomes
Total visual analog scale (VAS)
Time frame: Change from baseline VAS at 4th and 8th weeks visits
Sinonasal Outcome Test-22 (SNOT-22)
Time frame: Change from baseline SNOT-22 at 4th and 8th visits
Peak nasal inspiratory flow (PNIF)
Time frame: Change from baseline PNIF at 4th and 8th visits
Butanol olfactory threshold test (BuOT)
Time frame: Change from baseline BuOT at 4th and 8th visits
Total immunoglobulin E (IgE) level
Time frame: Change from baseline total IgE level at 4th and 8th visits
Presence of peripheral eosinophilia (PE, > 500/mcl) in blood samples
Time frame: Change from baseline presence of peripheral eosinophilia at 4th and 8th visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yesim Tuncok, MD principal investigator
Dokuz Eylul University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Emthexate, Prednol and Mometasone Furoate in people with Nasal Polyposis, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lund-Kennedy endoscopic grading system (NPS) (time frame: Change from baseline NPS at 4th and 8th weeks visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.