Clinical trial NCT05450471: Effectiveness of Endonasal Polymeric Implant for Chronic Rhinosinusitis
Official title: Effectiveness of Endonasal Polymeric Implant in the Treatment of Chronic Eosinophilic and Central Compartment Rhinosinusitis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rhinosinusitis Chronic
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Nasal Obstruction
timeFrame: Day 15 after intervention
measure: Nasal Endoscopic Evaluation
timeFrame: Day 15 after intervention
measure: Sino Nasal Outcome Test
timeFrame: Day 15 after intervention
Secondary outcomes:
measure: Morning serum level of cortisol, albumin and serum globulin
timeFrame: Day 15 after intervention
measure: Morning serum level of cortisol, albumin and serum globulin
timeFrame: Day 60 after intervention
measure: ACTH - adrenocorticotropic hormone
timeFrame: Day 15 and 60 aftern intervention
measure: ACTH - adrenocorticotropic hormone
timeFrame: Day 15 after intervention
measure: Complete blood count
timeFrame: Day 60 after intervention
measure: total and serum IgE (blood test)
timeFrame: Day 15 after intervention
measure: total and serum IgE (blood test)
timeFrame: Day 60 after intervention
measure: Cortisol level in 24-hour urine
timeFrame: Day 15 after intervention
measure: Cortisol level in 24-hour urine
timeFrame: Day 60 after intervention
measure: Intraocular pressure profile - IOP
timeFrame: Day 15 after intervention
measure: Intraocular pressure profile - IOP
timeFrame: Day 60 after intervention
measure: Patient comfort
timeFrame: Day 15 after intervention
measure: Patient comfort
timeFrame: Day 60 after intervention
measure: Patient self-reported perception of improvement and satisfaction with the implant
timeFrame: Day 15 after intervention
measure: Patient self-reported perception of improvement and satisfaction with the implant
timeFrame: Day 60 after intervention
measure: Adverse events
timeFrame: Day 15 after intervention
measure: Adverse events
timeFrame: Day 60 after intervention
measure: Nasal Obstruction
timeFrame: Day 45 after intervention
measure: Nasal Obstruction
timeFrame: Day 90 after intervention
measure: Nasal Endoscopic Evaluation
timeFrame: Day 45 after intervention
measure: Nasal Endoscopic Evaluation
timeFrame: Day 90 after intervention
measure: Sino Nasal Outcome Test
timeFrame: Day 45 after intervention
measure: Sino Nasal Outcome Test
timeFrame: Day 90 after intervention
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Luiz Eduardo Flório Junior
state: SP
Study officials:
References: