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49 active trials for Rhinosinusitis

Dupilumab in CRSsNP

Primary Objective: Part A and B: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan and sinus total symptom score (sTSS) compared to placebo Secondary Objectives: Part A To evaluate the efficacy of dupilumab as assessed by the reduction at Week 52 in sinus opacification on CT scan and total symptom score (sTSS) compared to placebo To evaluate the efficacy of dupilumab in improving CRSsNP symptoms at Weeks 24 and 52 compared to placebo To evaluate the effect of dupilumab on health related quality of life at Weeks 24 and 52 (HRQoL) compared to placebo To evaluate the effect of dupilumab on CRSsNP overall disease severity at Weeks 24 and 52 compared to placebo To evaluate the effect of dupilumab at Weeks 24 and 52 in the subgroups of participants with comorbid asthma compared to placebo To evaluate the ability of dupilumab to reduce the incidence of participants with CRSsNP worsening/acute sinusitis who require treatment with antibiotics, systemic corticosteroids (SCS) or sinus surgery compared to placebo To evaluate the effects of dupilumab on transcriptomic signatures associated with CRSsNP and type 2 inflammation To evaluate the effect of dupilumab in the subgroup of participants with screening blood eosinophils count ≥300 cells/mm3 compared to placebo To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo Assessment of immunogenicity to dupilumab over time compared to placebo Part B To evaluate the efficacy of dupilumab in improving CRSsNP symptoms at Week 24 compared to placebo in patients To evaluate the effect of dupilumab on health related quality of life (HRQoL) compared to placebo To evaluate the effect of dupilumab on CRSsNP overall disease severity compared to placebo To evaluate the effect of dupilumab in the subgroups of participants with comorbid asthma compared to placebo To evaluate the ability of dupilumab to reduce the incidence of participants with CRSsNP worsening/acute sinusitis who require treatment with antibiotics, SCS, or sinus surgery compared to placebo To evaluate the effects of dupilumab on transcriptomic signatures associated with CRSsNP and type 2 inflammation To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo Assessment of immunogenicity to dupilumab over time compared to placebo

GentStart: October 2020
Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps

Asthma and chronic rhinosinusitis (CRS) are inflammatory diseases of the respiratory tract, asthma from the lower part, and CRS, from the upper part. In theory, these parts are correlated as if they are one single organ, namely "united airways", which means that if one is affected by any condition, the other might be impacted as well. However, this relationship has not yet been described down to the cellular and molecular levels. By investigating patients that have (1) asthma and CRS with nasal polyp, (2) asthma and CRS without nasal polyp, and (3) just CRS with nasal polyp, we aim to determine the correlation of the upper and lower part of the respiratory tract. At first, the characterization of disease will be determined by established clinical criteria, such as lung function, blood analysis for the presence of eosinophils (a type of white cells), and nasal polyp score. To continue, in-depth analysis of nose, oropharynx, and lung samples will help gain information about the inflammatory profile and local microbiome of the three different groups of patients through molecular and cellular assays. The results of this study will help to describe the hypothesis of the united airways which will provide better guidance for medical treatment of asthma and CRS with or without polyp, thus improving the life quality of patients.

Start: September 2021
Dupilumab for Prevention of Recurrence of CRSwNP After ESS

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.

Montreal, QuebecStart: May 2021