Clinical Research Directory

Biologics in Chronic Rhinosinusitis With Nasal Polyposis

The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans. Until recently, the only medical treatment options available for patients with CRSwNP were corticosteroids, with surgery reserved for medical failure. The development of biologic medications over the last 5 years has revolutionized the treatment of CRSwNP. Three biologic medications have been FDA approved and available for the treatment of CRSwNP: dupilumab, omalizumab, and mepolizumab. However, data from the clinical trials for these drugs do not show universal improvement across all patients with CRSwNP. In fact, there is a wide range of outcomes for patients in these trials. The result is that clinicians have no way of knowing which specific biologic would be the best option for any given patient, nor do they know whether biomarkers can be used to predict response to biologics. It is hoped that findings from this study will inform whether any one biologic has superior outcomes to another and whether clinicians can identify patients at baseline who are most likely to improve on biologic therapy.

Craniosacral Osteopathic Treatment for Chronic Sinusitis

Chronic rhinosinusitis (CRS) is a common inflammatory condition that significantly impairs quality of life and is often insufficiently managed with standard medical therapy alone. Emerging evidence suggests that manual therapy approaches, including osteopathic manipulative treatment, may provide additional clinical benefits by improving lymphatic drainage, modulating autonomic function, and enhancing mucociliary clearance. This randomized controlled trial aims to investigate the effectiveness of craniosacral osteopathic manipulative treatment (OM-KST) as an adjunct to standard medical therapy in individuals with chronic rhinosinusitis. Participants diagnosed with CRS will be randomly allocated into two groups: a control group receiving standard medical treatment and an intervention group receiving OM-KST in addition to medical treatment. The intervention will consist of an 8-session craniosacral osteopathic protocol applied over 4 weeks. Outcomes will be assessed at baseline, post-intervention, and follow-up periods using validated clinical and patient-reported measures. Primary and secondary outcomes will include symptom severity, nasal obstruction, pain threshold, endoscopic findings, and quality of life (e.g., SNOT-22, NOSE, EuroQol-5D). This study is designed to provide high-level evidence on the clinical effectiveness of a multidisciplinary and integrative treatment approach for CRS, addressing both subjective symptoms and objective clinical findings.

FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps

Chronic rhinosinusitis with nasal polyps is a condition that causes long-lasting inflammation and swelling in the nose and sinuses and may lead to nasal blockage, nasal discharge, facial pressure, and reduced sense of smell. Functional Endoscopic Sinus Surgery (FESS) is a surgical treatment used when medical treatment has not adequately controlled the condition. Bleeding during FESS can make it difficult for the surgeon to see and operate safely. This randomized controlled trial will compare FESS performed with and without preoperative intranasal desmopressin in patients with chronic rhinosinusitis with nasal polyps. Patients will be randomly assigned to one of two groups. The intervention group will receive 20 micrograms of intranasal desmopressin 30-60 minutes before surgery, while the control group will undergo FESS without preoperative desmopressin. The study will assess intraoperative blood loss, quality of the surgical field, operative time, surgeon satisfaction, and perioperative complications. The study will include patients undergoing elective FESS at the Department of Otorhinolaryngology, Services Hospital, Lahore. The purpose of this study is to determine whether preoperative intranasal desmopressin can reduce bleeding and improve the surgical field during FESS. The findings may provide local evidence to help inform perioperative management of patients undergoing FESS for chronic rhinosinusitis with nasal polyps.

Endotypic Stability in CRS

A Case control study with 150 cases and 50 controls will be conducted. Immunologic (cytokines measurements in nasal secretions and sinonasal tissues), histopathologic (tissue eosinophilia) and clinical parameters (Lund-Mackay and Lund-Kennedy score, lung function tests), surveys (SNOT- 22, SF-36 quality of life survey) will be compared between different groups of patients

Opioid-Free Anesthesia in FESS: A Prospective ERAS Study

1. Information for Patients and Families What is this study about? When patients undergo functional endoscopic sinus surgery (FESS), strong pain relievers called opioids are traditionally used during anesthesia. While effective, opioids can sometimes cause unwanted side effects such as nausea, vomiting, dizziness, or prolonged recovery times. This study investigates an "Opioid-Free Anesthesia" (OFA) approach combined with Enhanced Recovery After Surgery (ERAS) protocols. ERAS is a modern, science-based care pathway designed to help patients recover faster and more comfortably after surgery. Why is this study important? The goal of this study is to see if skipping opioids during sinus surgery-and using alternative pain-management techniques instead-leads to better perioperative outcomes. We want to find out if patients experience less pain, fewer side effects (like nausea), and a quicker, safer return to their daily routines. What will happen if you participate? If you fit the criteria and agree to join, your surgical journey will follow the standard ERAS protocol, but your anesthesia will be managed without conventional opioid medications. Researchers will closely monitor your comfort, pain levels, and recovery speed before, during, and after your sinus surgery. 2. Technical Summary for Health Care Providers Official Study Title: Opioid-Free Anesthesia in Functional Endoscopic Sinus Surgery: Effects on Perioperative Outcomes - A Prospective Observational ERAS Study Study Rationale and Objective: Traditional opioid-based anesthesia is often associated with opioid-induced side effects (OIAEs) such as postoperative nausea and vomiting (PONV), respiratory depression, and delayed discharge. This prospective observational study aims to evaluate the clinical impact of Opioid-Free Anesthesia (OFA) embedded within an Enhanced Recovery After Surgery (ERAS) pathway for patients undergoing elective Functional Endoscopic Sinus Surgery (FESS). The primary focus is to assess whether an OFA-ERAS strategy optimizes perioperative outcomes, stabilizes intraoperative hemodynamics, and minimizes recovery times compared to historical opioid-based standards. Study Design: Prospective, Observational Study. Estimated Enrollment: 104 patients. Setting: Perioperative tracking following strict institutional ERAS principles.

Efficacy of Bee Venom Phonophoresis in Treating Chronic Sinusitis:

This double-blind, randomized controlled trial (BEE-SONIC) aims to evaluate the efficacy of bee venom phonophoresis in the treatment of chronic sinusitis. Thirty adult patients (aged 18-65 years) with clinically diagnosed chronic or acute sinusitis will be randomized into two groups: the intervention group will receive bee venom phonophoresis using low-to-moderate intensity ultrasound, while the control group will receive standard care consisting of oral decongestants and saline nasal irrigation. Primary outcomes include improvement in symptom severity (SNOT-22, Visual Analog Scale) and quality of life (SF-33). Secondary outcomes include reduction in facial pain, nasal congestion, and patient satisfaction. Data will be collected at baseline, midpoint, and post-intervention, and analyzed using paired t-tests and ANOVA. The study has received ethics approval from Sinai University's Human Research Ethics Committee, and informed consent will be obtained from all participants.

Dupilumab in CRSsNP

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

Post-radiotherapy Rhinosinusitis in Children

Chronic rhinosinusitis (CRS) is a frequent complication of facial cancer treatment, mainly related to radiotherapy. However, while radiological involvement is frequent, clinical expression seems less important. Few studies have investigated the incidence of this condition in the pediatric population while its evolution seems to be very chronic even if a partial improvement may occur with time. Our objective is therefore to study the impact of CSR in children treated for cancer of the cervicofacial region, to evaluate its incidence and medium-term evolution in order to determine whether it is necessary to set up a specific follow-up in these patients. The clinical impact of CSR is assessed by a specific SNOT 22 questionnaire in children treated for a head-neck mesenchymal malignancy in comparison with a control population consisting of children treated for a mesenchymal malignancy of non-head-neck location.

Eosinophils Endotypes in Chronic Airway Inflammatory Diseases

Asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) are frequently described as unified airway inflammatory diseases. Both heavily impacts quality of life with substantial productivity loss. They share the same pathophysiologic pattern based upon proTh2 immune response with blood eosinophils recruitment. Eosinophils are the major actor of persistent mucosal inflammation by promoting their own survival, by attracting other inflammatory cells and by producing cytotoxic proteins involved in mucosal remodeling. Promising anti-Th2 therapeutic approaches (i.e.anti-IgE, anti-interleukin 5 (IL-5), anti-IL-4, anti-IL-13) are considered as effective alternative options to long-term corticosteroid treatment. Their advantage in recalcitrant CRSwNP is under consideration. Moreover, we still need to delineate the good responders to improve theirs indications. The objective is to assess blood eosinophil immunophenotypes in asthma or CRSwNP. Flow cytometric expression of activation markers on eosinophil membrane will be compared with a group of healthy subjects. Innovative data on eosinophil involvement in airway diseases will be obtained. The major outcome will be to depict patients' endotypes for a better selection of immunotherapies.

Genetic Factors in Chronic Sinusitis

The purpose of this study is to learn more about the genetics of chronic sinusitis and identify genes involved in chronic sinusitis.

A Study Evaluating the Efficacy of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) Combined With Stapokibart in the Treatment of Type 2 Chronic Rhinosinusitis

Through a prospective study, the efficacy of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) in the surgical treatment of patients with type 2 chronic rhinosinusitis was verified. The aim was to provide evidence-based medical evidence for the effectiveness of local minimally invasive surgery combined with biologics in the treatment of type 2 chronic rhinosinusitis.

Steroid-eluting Sinus Stent for Chronic Rhinosinusitis Patients With Uncontrolled Postoperative Symptoms

Stent-001 study is a randomized controlled clinical trial with the steroid-eluting Sinus in 96 chronic rhinosinusitis patients with uncontrolled postoperative symptoms