Clinical Trials Logo

Clinical Trial Summary

Objective: The objective of this study is to evaluate a steroid-embedded Terpolymers polymer implant of L-lactide and trimethynele carbonate (TCM) at the level of disease control in patients with eosinophilic and central compartment chronic rhinosinusitis (CRS) after placement of the endonasal device, compared to a control group (placebo). The secondary objectives of this study are to assess comfort, perception of improvement and satisfaction, as well as adverse events. Methods: A randomized controlled trial will be carried out, with a blinded participant, therapist and evaluator. Patients over 18 years of age, with chronic rhinosinusitis (CRS) who have already undergone endoscopic sinus surgery (CENS), but who do not have the disease under control and, therefore, with an indication for a new CENS, will be selected. Participants will come from the otorhinolaryngology outpatient clinic of the academic and public service of the University of São Paulo - USP. Eligible patients will receive either the Terpolymers L-lactide and trimethynele carbonate (TCM) polymer implant placement or the placebo polymer. The primary outcome will be the control of the symptoms of chronic uncontrolled rhinosinusitis that will be evaluated through the NOSE Questionnaire, a nasal endoscopic evaluation based on the Lund-Kennedy criteria and the SNOT-22 Questionnaire. The sample size calculation was performed based on a difference between the intervention and placebo groups of 30% for cases that achieved disease control, resulting in a sample of 36 participants (18 in each group). Data will be analyzed using mixed linear models.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05450471
Study type Interventional
Source University of Sao Paulo
Contact
Status Recruiting
Phase Phase 3
Start date August 20, 2021
Completion date December 15, 2022

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05923047 - Mepolizumab and In-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study. Phase 4
Not yet recruiting NCT05836935 - Role of Imaging in Complications of Sinusitis N/A
Not yet recruiting NCT05167552 - Treatment of Allergic Rhinitis and Chronic Polypous Rhinosinusitis With Olfactory Mucosa-derived Mesenchymal Stem Cells Phase 1/Phase 2
Withdrawn NCT04420052 - Effects of Osteopathic Manipulative Treatment in Chronic Non-allergic Rhinosinusitis N/A
Completed NCT04703673 - Sinolpan® Pharmacy Non-interventional Study - Quality of Live
Recruiting NCT05639686 - TIVA vs TXA in Sinus Surgery to Evaluate Operative Blood Loss and Surgical Field Quality N/A
Recruiting NCT05015530 - Impact of Symbiofilm On Nasal Microbiota
Not yet recruiting NCT06105346 - Prevalence of ENT Diseseas
Terminated NCT03675022 - Effect of Dupilumab on Sleep Apnea in Patients With Rhinosinusitis Early Phase 1