View clinical trials related to Sinusitis.
Filter by: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
Endoscopic sinus surgery (ESS) is a well-established treatment strategy for medically refractory chronic rhinosinusitis. Middle meatus spacers are currently used following ESS to prevent scarring, synechiae formation, and middle turbinate lateralization. A 2012 systematic review favored spacers compared to no spacers, with a follow up 2013 systematic review finding no difference between the use of absorbable and non-absorbable spacers. This review, however, noted that steroidal spacers may reduce middle meatus scarring and adhesions. More recent data has shown the effectiveness of steroid releasing middle meatus implants in preventing middle turbinate lateralization, reducing synechiae formation, and reducing revision surgery. However, these stents are costly, and may result in excess crusting postoperatively, which limits their use in some settings. Another study investigated the use of steroid-impregnated absorbable packing materials, and demonstrated the safety and utility of this method of middle meatus packing. However, a limitation to this study was overall low enrollment with only 19 total patients enrolled. The purpose of this project is to add to the existing body of evidence regarding middle meatus spacers, by studying the impact of steroid impregnated, bioabsorbable hemostatic packing (Hemopore®, Stryker) on postoperative visualization and scar formation.
This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, PK, PD and immumogenicity of CM310 in comparison to placebo in addition to a background treatment of mometasone furcate nasal spray (MFNS) in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).
This study will evaluate the effect of CBP-201, rademikibart, in adult patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).
The purpose of the research is to assess the effectiveness of a dose of intravenous tranexamic acid (TXA) given intraoperatively to reduce postoperative bleeding after endoscopic sinus or nasal surgery (e.g. septoplasty, endoscopic sinus surgery, turbinate surgery). This medication has been shown to decrease blood loss during this type of surgery, but the implications for bleeding following surgery are unclear. Any impact on postoperative bleeding will be assessed over the first 7 days following surgery leading up to the first scheduled postoperative clinic visit. Patients will keep a standardized daily diary of their bleeding experience by indicating on a 0-10 visual analog scale (VAS) their impression of their bleeding. The primary outcome is the patient-reported visual analog scale (VAS) bleeding score on each day after surgery. The secondary outcomes include the the frequency with which the otolaryngology resident service is requested to evaluate patients in the recovery unit for postoperative bleeding concerns and the frequency of interventions such as application of hemostatic materials, packing, cautery, and/or return to the operating room.
This non-interventional study investigates the Quality of Life of patients suffering from rhinosinusitis. Patients who seek advice in a pharmacy and choose to intake Sinolpan® or Sinolpan® forte or to use nasally applied α-sympathomimetics can participate in this anonymous patient survey.
Primary Objective: - To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) Secondary Objectives: - To evaluate the efficacy of treatment with dupilumab to reduce sinus opacification in a population with allergic fungal rhinosinusitis (AFRS) at Week 24 - To assess the efficacy of dupilumab to reduce the need for rescue treatments - To evaluate the efficacy of treatment with dupilumab in improving symptoms in AFRS - To evaluate the efficacy of dupilumab to reduce nasal polyp formation in participants with AFRS - To evaluate the efficacy of dupilumab in improving overall symptom severity and quality of life in AFRS - To evaluate the efficacy of dupilumab in improving sense of smell in participants with AFRS - To explore the effect of dupilumab as assessed by three-Dimensional CT volumetric measurement of the paranasal sinuses - To evaluate the safety and tolerability of dupilumab when administered to participants with AFRS - To evaluate the pharmacokinetics (PK) of dupilumab in participants with AFRS - To characterize the effect of dupilumab on total IgE and specific IgE - To assess immunogenicity to dupilumab in participants with AFRS
Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: - To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score (sTSS) 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
An international consortium of leading medical experts in the field of chronic respiratory disease, the research team of Galenus Health and the non-profit organization EUFOREA (European Forum for Research and Education in Allergy and Airway diseases) has been conceived to conduct real-life outcome research. The Galenus Health digital platform consisting of a mobile application for patients and an online dashboard for physicians will be implemented in each of the participating centres. The data will be centralized in a pseudonymized database and will be the basis of the Chronic RhinoSinusitis Outcome Registry.
This is a multi-center, double-blind, randomized, active controlled, parallel group phase 4 clinical trial to re-confirm the efficacy and safety of cefetamet pivoxil formulation in sinusitis patients