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D009298: Nasal Polyps

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug2338 Mepolizumab Wiki 0.45
drug3738 Standard of care Wiki 0.20
drug2916 Placebo Wiki 0.04

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D011127 Polyps NIH 1.00

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0100582 Nasal polyposis HPO 1.00

Clinical Trials

Navigate: Correlations   HPO

There is one clinical trial.


1 A Randomised, Double-blind, Placebo Controlled, Parallel Group Phase III Study to Assess the Clinical Efficacy and Safety of 100 mg SC Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) / Eosinophilic Chronic Rhinosinusitis (ECRS) MERIT: Mepolizumab in Eosinophilic Chronic RhinosinusITis Study

This is a randomized, double blind, placebo controlled, parallel group phase III study designed to assess the clinical efficacy and safety of 100 milligrams (mg) subcutaneous (SC) mepolizumab treatment in adults with CRSwNP/ECRS for the purpose of registration in Japan and China. Approximately 160 participants will be randomized in a 1:1 ratio to receive either 100 mg SC mepolizumab or placebo SC. The study will include a 4-week run-in period followed by randomization to a 52-week treatment period, where participants will be administered 4-weekly doses of mepolizumab or placebo via a pre-filled safety syringe device (SSD) injection.

NCT04607005
Conditions
  1. Nasal Polyps
Interventions
  1. Drug: Mepolizumab
  2. Drug: Placebo
  3. Drug: Standard of care
MeSH:Nasal Polyps Polyps
HPO:Nasal polyposis

Primary Outcomes

Description: NP score is graded and based on NP size recorded as the sum of the right and left nostril scores with a range of 0-8; higher scores indicate worse status. Individual score ranges from 0 (no polyps) to 4 (large polyps causing almost complete congestion/ obstruction of the inferior meatus) within each nostril.

Measure: Change from Baseline in total endoscopic NP score at Week 52 (scores on a scale)

Time: Baseline (Day 0) and at Week 52

Description: Participant will be asked to indicate on a VAS the severity of 5 nasal polyposis symptoms (one VAS for each symptom) and symptoms overall: 1. nasal obstruction; 2. nasal discharge; 3. mucus in the throat; 4. loss of smell; 5. Facial pain; 6. overall VAS symptoms score. The left-hand side of the scale (0) represents "None" and the right-hand side of the scale (100) represents "As bad as you can imagine". The participant selects a point on the line that represents their current state on the continuum. VAS will be collected using an electronic Diary, suitably pixilated to allow the selection of all integers from 0 to 100.

Measure: Change from Baseline in mean nasal obstruction visual analogue scale (VAS) score (scores on a scale)

Time: Baseline (Day 0) and up to 52 weeks

Secondary Outcomes

Description: SNOT-22 is a 22-item measure of disease specific health related quality of life (HRQoL). Participants will be asked to rate the severity of their condition on each of the 22 items over the previous 2 weeks using a 6-point rating scale of 0-5 including: 0 =Not present/no problem; 1 =Very mild problem; 2 = Mild or slight problem; 3 = Moderate problem; 4 = Severe problem; 5=Problem as "bad as it can be". The total score range for the SNOT-22 is 0-110, where higher scores indicate greater disease impact.

Measure: Change from Baseline in sino-nasal outcome test (SNOT)-22 total score at Week 52 (scores on a scale)

Time: Baseline (Day 0) and at Week 52

Description: Participant will be asked to indicate on a VAS the severity of 5 nasal polyposis symptoms (one VAS for each symptom) and symptoms overall: 1. nasal obstruction; 2. nasal discharge; 3. mucus in the throat; 4. loss of smell; 5. Facial pain; 6. overall VAS symptoms score. The left-hand side of the scale (0) represents "None" and the right-hand side of the scale (100) represents "As bad as you can imagine". The participant selects a point on the line that represents their current state on the continuum. VAS will be collected using an electronic Diary, suitably pixilated to allow the selection of all integers from 0 to 100.

Measure: Change from Baseline in mean overall VAS symptom score (scores on a scale)

Time: Baseline (Day 0) and up to 52 weeks

Description: Participant will be asked to indicate on a VAS the severity of 5 nasal polyposis symptoms (one VAS for each symptom) and symptoms overall: 1. nasal obstruction; 2. nasal discharge; 3. mucus in the throat; 4. loss of smell; 5. Facial pain; 6. overall VAS symptoms score. The left-hand side of the scale (0) represents "None" and the right-hand side of the scale (100) represents "As bad as you can imagine". The participant selects a point on the line that represents their current state on the continuum. VAS will be collected using an electronic Diary, suitably pixilated to allow the selection of all integers from 0 to 100.

Measure: Change from Baseline in the mean composite VAS score [combining VAS scores for nasal obstruction, nasal discharge, mucus in the throat and loss of smell] (scores on a scale)

Time: Baseline (Day 0) and up to 52 weeks

Description: The LMK CT scoring system is based on localization with points given for degree of opacification: 0 =normal, 1 = partial opacification, 2 = total opacification. These points are then applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, frontal sinus on each side. The osteomeatal complex (OC) is graded as 0 = not occluded, or 2 = occluded deriving a maximum score of 12 per side. The range for the LMK CT score is therefore 0-24 when summed across both sides.

Measure: Change from Baseline in Lund Mackay (LMK) computed tomography (CT) score at Week 52 (scores on a scale)

Time: Baseline (Day 0) and at Week 52

Description: Participant will be asked to indicate on a VAS the severity of 5 nasal polyposis symptoms (one VAS for each symptom) and symptoms overall: 1. nasal obstruction; 2. nasal discharge; 3. mucus in the throat; 4. loss of smell; 5. Facial pain; 6. overall VAS symptoms score. The left-hand side of the scale (0) represents "None" and the right-hand side of the scale (100) represents "As bad as you can imagine". The participant selects a point on the line that represents their current state on the continuum. VAS will be collected using an electronic Diary, suitably pixilated to allow the selection of all integers from 0 to 100.

Measure: Change from Baseline in mean individual VAS symptom score for loss of smell (scores on a scale)

Time: Baseline (Day 0) and up to 52 weeks

Description: NP surgery is defined as any procedure involving instruments resulting in incision and removal of tissue from the nasal cavity (for example polypectomy). Additionally, the number of courses of systemic steroids and reason for treatment will be recorded throughout the study.

Measure: Time to first nasal surgery or course of systemic corticosteroids (CS) for CRSwNP/ECRS up to Week 52

Time: Up to 52 weeks

HPO Nodes


Reports

Data processed on September 26, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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691 reports on MeSH terms

HPO

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