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Nasal Polyps clinical trials

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NCT ID: NCT05143502 Active, not recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.

Start date: January 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the work is to examine the efficacy of montelukast as an adjunct to steroid therapy in patients with chronic rhinosinusitis with nasal polyps.

NCT ID: NCT04851964 Active, not recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis

WAYPOINT
Start date: April 22, 2021
Phase: Phase 3
Study type: Interventional

A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants with Severe Chronic Rhinosinusitis with Nasal Polyposis

NCT ID: NCT04596189 Active, not recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Dupilumab for Prevention of Recurrence of CRSwNP After ESS

Start date: May 25, 2021
Phase: Phase 4
Study type: Interventional

The investigators believe that administering Dupilumab during the pre- and peri-operative period of surgery for chronic rhinosinusitis with nasal polyps (CRSwNP) will safely downregulate Type 2 inflammation of the healing sinus environment and will allow for better coordinated and more effective mucosal healing. Specifically, the investigators believe that endoscopic signs and symptoms of recurrence will be reduced in the Dupilumab-treated group, and that this will be reflected in quality of life (QOL). Additionally, by reducing Type 2 inflammation at the time of surgery, Dupilumab may offer an additional benefit by decreasing operative bleeding. The investigators propose to perform a placebo-controlled, prospective, real-world trial in patients with CRSwNP undergoing revision surgery for CRSwNP to verify whether recurrences after endoscopic sinus surgery (ESS) can be prevented by controlling Type 2 inflammation during the peri-operative period using Dupilumab. A series of seven injections of Dupilumab (or placebo) will be administered to symptomatic patients undergoing ESS for CRSwNP. Beginning 4 weeks prior to surgery and continuing for 8 weeks post-surgery, q2 weekly injections will be administered to reduce Type 2 inflammation at time of ESS and during the post-operative recovery period. Principal outcome will be absence of recurrence of mucosal oedema of the sinus cavity as assessed by endoscopy. Secondary objectives will assess Polyp size, sinus symptomatology, quality of life, smell and asthma control. Exploratory analyses will assess microbiome and gene expression profiles to better understand molecular mechanisms implicated in CRSwNP pathophysiology, and to identify the pathways implicated by modulation of Type 2 inflammation.

NCT ID: NCT04286542 Active, not recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Mediators in Nasal Hyperreactivity in Allergic Rhinitis and Chronic Rhinosinusitis

Start date: January 20, 2020
Phase: N/A
Study type: Interventional

Rhinitis, or inflammation of the nasal mucosa, can present with nasal obstruction, nasal discharge, itch or sneezing. If the sinusal mucosa is involved as well, it is called rhinosinusitis and facial pain or loss of smell is possible. Several causes are known, such as an underlying allergy ("allergic rhinitis", AR). If at least 2 symptoms are present for at least 12 weeks, it is called "chronic rhinosinusitis" (CRS). Up to 2/3 of the AR and CRS patients have symptoms upon exposure to triggers such as sudden temperature changes, smoke, fragrances… a phenomenon called "nasal hyperreactivity" (NHR). It is currently not clear why some patients suffer NHR while others do not. In this study, the investigators want to identify the mediators associated with NHR in patients with allergic rhinitis, chronic rhinosinusitis and healthy control subjects.To do so, participants will be provoked with cold, dry air in order to objectively diagnose NHR. Before and after provocation, the peak nasal inspiratory flow will be measured and samples will be collected (nasal secretions, biopsies).

NCT ID: NCT04157335 Active, not recruiting - Nasal Polyposis Clinical Trials

Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)

ORCHID
Start date: November 25, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group, international, multicenter, Phase 3 study to evaluate the efficacy and safety of repeat dosing of benralizumab 30 mg administered subcutaneously (SC) versus placebo in patients with severe nasal polyposis.

NCT ID: NCT03973749 Active, not recruiting - Clinical trials for Aspirin-exacerbated Respiratory Disease

Effects of a High or Low Salycilate Diet on Urinary LTE4 and Clinical Features in AERD

AERD
Start date: February 2, 2017
Phase: N/A
Study type: Interventional

On day one, two groups of nine patients each will respectively recieve the tree daily meals (breakfast, Lunch and dinner) in a controled clinical setting. Group 1 will recieve a low-salycilate diet, and group 2 a high-salycilate diet. Two hours after each meal, urinary Leucotriene E4, FEV1, FVC, FEV1/FVC and total nasal resistance will be measured. On day 7, after clearance time, group 1 will recieve high-salycilate diet and group 2 low salycilate diet and the same measurements will be obtained.

NCT ID: NCT03943121 Active, not recruiting - Sinusitis Clinical Trials

The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

Start date: October 8, 2018
Phase: N/A
Study type: Interventional

The treatment of eosinophilic sinusitis with nasal polyps is difficult and challenging. After endoscopic sinus surgery(ESS), complications such as edema, scar formation, adhesions, sinus stenosis and recurrence of polyps are prone to occur. Investigators aim to assess the efficacy and safety of Steroid-eluting stent when implanted in sinus in patients following ESS with eosinophilic sinusitis and nasal polyps.The randomized, double-blind, controlled clinical trial enrolled patients with eosinophilic sinusitis and nasal polyps. After endoscopic bilateral sinus surgery, the Steroid-eluting stents were randomly implanted in one side of the sinus and the other side as a control. Primary outcomes are change in the Lund-Kennedy endoscopic score.The primary outcomes will be measured in baseline, week4,week 8 and week 12. Secondary outcomes include the changes in symptoms measured by Visual analog score and nasal patency (nasal airway resistance and nasal cavity volume), exhaled nasal nitric oxide. The investigators also evaluate change in inflammatory cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17, IL-22, IL-25, interferon-γ, tumor necrosis factor-α, transforming growth factor-β, Leukotriene,Eotaxin) in nasal secretions. The secondary outcomes will be measured in baseline, week4, week8 and week12. Mucosal pathology assessment will be performed at 4 weeks postoperatively.Sinus CT scan will be conducted at 8 weeks after surgery. Changes in serum cortisol are monitored at baseline,week4 and week12 postoperatively. All adverse events are recorded throughout the experiment

NCT ID: NCT03704415 Active, not recruiting - Asthma Clinical Trials

Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)

Start date: October 23, 2018
Phase: N/A
Study type: Interventional

This randomized study compares operative techniques in chronic rhinosinusitis with polyposis (CRSwNP) surgery. It aims to evaluate outcomes in asthma and CRSwNP, safety and costs. The investigators want to see if patients with certain clinical and/or genetic predispositions will benefit from extended surgery. They also aim to find biomarkers for detection and management models for of severe airway inflammation and to further develop markers for progressive disease forms.

NCT ID: NCT02533206 Active, not recruiting - Sinusitis Clinical Trials

Pilot Study of The EPIC Trial

Start date: August 2015
Phase: N/A
Study type: Interventional

Chronic sinusitis is one of the most common chronic diseases in North America, with over 5% of the Canadian population affected by the disease. Until now, treatment with surgery has been performed only in the operating room. Recently a smaller surgical procedure that is done in the clinic for some patients with chronic sinusitis with polyps has been found to result in symptom control that appears to be similar to that which occurs with sinus surgery. Performing the smaller clinical procedure has advantages including a shorter recovery time for the patient, a much lower cost to the health care system for the procedure, and a shorter patient wait time for the procedure to be done in comparison to sinus surgery performed in the operating room. To know with greater certainty that the procedure performed in the clinic is as good as the operating room sinus surgery, a large multiple investigator randomised clinical trial has been designed. However, before carrying out that trial, a practice run or internal pilot study of that trial is required to ensure that the trial can recruit patients at the rate that is anticipated and that the procedures to obtain the measurements being used for the larger study are adequate.

NCT ID: NCT01906697 Active, not recruiting - Sinusitis Clinical Trials

The Effect of RF Turbinoplasty in Polypoid Change of Middle Turbinates

Start date: May 2011
Phase: Phase 3
Study type: Interventional

The aim of this study is to evaluate the effect of middle turbinate Radio Frequency (RF) turbinoplasty with middle turbinate resection and medialization