Trial · NCT05143502
Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.
NCT05143502, Phase 1, Phase 2, Unknown, Assiut University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps. Trials, record NCT05143502. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05143502
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.
- NCT number
- NCT05143502
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Assiut University
- Conditions
- Montelukast, Chronic Rhinosinusitis With Nasal Polyps
- Interventions
- Montelukast, Prednisolone, Fluticasone Furoate
- First posted
- 2021-12-03
- Last updated
- 2022-03-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change at nasal polyp size | after 12 weeks from the start of treatment | Each CRSwNP patient will undergo nasal endoscopy to score the polyp size (0-4) in both nasal cavities using a modified Lildholdt scoring system: 0 = no nasal polyps. 1. small nasal polyps not reaching the inferior border of the middle turbinate. 2. nasal polyps reaching beyond the inferior border of the middle turbinate. 3. large nasal polyps reaching the lower edge of the inferior turbinate 4. very large nasal polyps in contact with the floor of the nasal cavity. |
| Secondary | Nasal symptoms. | after 12 weeks from the start of treatment | All participants will asked to score five sinonasal symptoms (nasal congestion/obstruction, anterior rhinorrhea, posterior rhinorrhea, loss of smell, and facial pain) from 0 to 4. 0 = symptom-free/no symptom. 1. mild symptom. 2. moderate symptom. 3. severe symptom. 4. very severe symptom. This score will be assessed at the screening visit and follow-up visits at 4, 8 and 12 weeks. The total five-symptom score (T5SS) obtained with the sum of the individual symptoms (0-20). |
| Secondary | Radiological evaluation | after 12 weeks from the start of treatment | CT scan of the nose and paranasal sinuses will performed to all patients before and after the treatment and staged using the Lund-Mackay (LMK) scoring system where each sinus (maxillar, anterior ethmoidal, posterior eth-moidal, frontal, esphenoidal) is scored for opacification (0, no opacity; 1, partial opacity; 2, total opacity), and the ostiomeatal complex is scored 0 (no obstruction) or 2 (obstruction). The uni-lateral score goes from 0 to 12 whereas the bilateral score goes from 0 to 24. |
| Secondary | Quality of life score | after 12 weeks from the start of treatment | Subjects will complete validated questionnaire related to general quality of life lCSD (International Classification of Sinus Disease) before and after treatment. The ICSD records patients' symptoms of facial pain and pressure; headache ;nasal blockage Or congestion; nasal discharge; disturbance of smell; and Over all discomfort on a 0 to 10 ordinal scale. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05143502
GET https://conductscience.org/api/trials/v1/NCT05143502/registered