Effectiveness of Endonasal Polymeric Implant for Chronic Rhinosinusitis

NCT ID: NCT05450471

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-20
• Study Completion Date: 2022-12-15

Brief 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.

Conditions

Rhinosinusitis Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

L-lactide and trimethynele carbonate Terpolymers polymer implant

The polymer implant will be placed in the ethmoidal region, at the same time that the nasal endoscopic examination will be performed. The polymer in this study is biocompatible. The polymers will be made in the biomaterials laboratory located at the Pontifical Catholic University of São Paulo (PUC-SP), located in the city of Sorocaba-SP. Polymers will be provided free of charge for the study.

Group Type: EXPERIMENTAL

Corticosteroid Topical

Intervention Type: DRUG

The L-lactide and trimethynele carbonate (TCM) Terpolymers polymer implant will be placed in the ethmoidal region, at the same time that the nasal endoscopic examination will be performed.

Placebo polymer implant

Placebo polymer implant

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

Corticosteroid Topical

The L-lactide and trimethynele carbonate (TCM) Terpolymers polymer implant will be placed in the ethmoidal region, at the same time that the nasal endoscopic examination will be performed.

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with chronic rhinosinusitis undergoing endoscopic sinus surgery, but who do not have the disease under control. The uncontrolled disease and its respective classification regarding the degree of the disease will be carried out through 3 assessments: 1) Nose Obstruction Symptom Evaluation Questionnaire (NOSE) validated version in Portuguese; 2) nasal endoscopic evaluation; and, 3) Sino Nasal Outcome Test Questionnaire (SNOT-22). Through the NOSE questionnaire, the patient's disease will be classified as "Controlled", "Partially Controlled" or "Uncontrolled (Uncontrolled)". Any variation in the endoscopic evaluation score based on the Lund-Kennedy Criteria will be considered an alteration. And for the SNOT-22 Questionnaire, changes will be considered when the total score varies by at least 11 points. Patients who present these 3 alterations will be considered to have the 'uncontrolled disease' and, therefore, will be eligible for the study.

Exclusion Criteria

• Patients with malformations, trauma and/or tumors in the nasal and paranasal sinuses will be excluded;
• Patients with a history of recent nasal surgery up to 6 months previously, with glaucoma and cataracts.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Luiz Eduardo Florio Junior

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Luiz Eduardo Flório Junior

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Luiz Eduardo Flório Junior, MD

Role: primary

luiz-florio@hotmail.com

55 15 98108-0412

Other Identifiers

USPStudy

Identifier Type: -

Identifier Source: org_study_id