A Phase 3 interventional study of Corticosteroid Topical and Placebo in Rhinosinusitis Chronic, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-08.
Sponsored by University of Sao Paulo · Phase 3, Interventional, and Treatment
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.
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's planned enrollment of 36 is below the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
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Exclusion Criteria:
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.
Drug: Corticosteroid Topical
Placebo polymer implant
Other: Placebo
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
Nasal Obstruction
Nasal Obstruction, Sistemic medication and Endoscopy (NOSE) questionnaire. NOSE is a method of evaluating the clinical control of chronic rhinosinusitis and is based on the evaluation of three aspects: nasal obstruction, nasal endoscopy and the need for systemic medication (antibiotics or steroids). The NOSE questionnaire consists of five questions concerning subjective assessment of the nasal obstruction within the past month. Each question can be answered usinga 5-point Likert scale from"0"(not a problem) up to"4"(severe problems with breathing). After addition of allitem values and multiplying the raw score with 5, severity of the patient's complaints can be scaled to range from 0 to 100. A score of 0 indicates no obstructivenasal problems and a score of 100 implies severe problems.
Time frame: Day 15 after intervention
Nasal Endoscopic Evaluation
The nasal endoscopic evaluation will be performed under topical anesthesia, with a rigid endoscope (4mm, 0° and/or 45°; Karl Storz) and its classification will be based on the Lund - Kennedy criteria. For this evaluation, each nostril is examined separately and three possible characteristics may be present, they are: polyps, nasal mucosa edema and/or secretion. For each evaluated characteristic, a score from 0 to 2 is assigned. For the evaluation of polyps, the score is applied as follows: 0=absent; 1=restricted to the middle meatus; and, 2=extension to nasal cavity. For the evaluation of nasal mucosa edema, the score is applied as follows: 0=absent; 1=mild or moderate edema; and 2= polypoid degeneration. For the evaluation of secretion, the score is applied as follows: 0=absent; 1=hyaline secretion; and, 2=mucopurulent or thick secretion.
Time frame: Day 15 after intervention
Sino Nasal Outcome Test
Sino Nasal Outcome Test (SNOT-22) The SNOT-22 Questionnaire is a modification of the SNOT-20, with 2 additional items on nasal obstruction and problems with smell and taste. The questionnaire assesses 22 items related to nasal symptoms that can impact the patient's personal and social life. Each item can get a score ranging from 0 (least possible problem) to 5 (greatest possible problem). Thus, this questionnaire has a final score that can range from 0 to 110 points. In this study, a significant clinical improvement will be considered when there is at least a variation of 11 points from one assessment to another.23 The validity and reliability of the SNOT-22 have already been previously tested in Portuguese.
Time frame: Day 15 after intervention
Morning serum level of cortisol, albumin and serum globulin
blood test
Time frame: Day 15 after intervention
Morning serum level of cortisol, albumin and serum globulin
blood test
Time frame: Day 60 after intervention
ACTH - adrenocorticotropic hormone
blood test
Time frame: Day 15 and 60 aftern intervention
ACTH - adrenocorticotropic hormone
blood test
Time frame: Day 15 after intervention
Complete blood count
A complete blood count (CBC) is a blood test used to evaluate your overall health and detect a wide range of disorders, including anemia, infection and leukemia. A complete blood count test measures several components and features of your blood, including: Red blood cells, which carry oxygen White blood cells, which fight infection Hemoglobin, the oxygen-carrying protein in red blood cells Hematocrit, the proportion of red blood cells to the fluid component, or plasma, in your blood Platelets, which help with blood clotting
Time frame: Day 60 after intervention
total and serum IgE (blood test)
blood test
Time frame: Day 15 after intervention
total and serum IgE (blood test)
blood test
Time frame: Day 60 after intervention
Cortisol level in 24-hour urine
urine test
Time frame: Day 15 after intervention
Cortisol level in 24-hour urine
urine test
Time frame: Day 60 after intervention
Intraocular pressure profile - IOP
ophthalmologic assessment - fluid overload test and the lens by slit lamp examination
Time frame: Day 15 after intervention
Intraocular pressure profile - IOP
ophthalmologic assessment - fluid overload test and the lens by slit lamp examination
Time frame: Day 60 after intervention
Patient comfort
self-reported on an analog scale from 0 to 100, where 0 indicates very uncomfortable and 100 indicates very comfortable
Time frame: Day 15 after intervention
Patient comfort
self-reported on an analog scale from 0 to 100, where 0 indicates very uncomfortable and 100 indicates very comfortable
Time frame: Day 60 after intervention
Patient self-reported perception of improvement and satisfaction with the implant
Measured on an analog scale from 0 to 100, where 0 indicates no change in symptoms and dissatisfaction, and 100 indicates resolved symptoms and satisfaction
Time frame: Day 15 after intervention
Patient self-reported perception of improvement and satisfaction with the implant
Measured on an analog scale from 0 to 100, where 0 indicates no change in symptoms and dissatisfaction, and 100 indicates resolved symptoms and satisfaction
Time frame: Day 60 after intervention
Adverse events
Adverse events will be measured through changes in blood and urine tests and also on a self-reported basis.
Time frame: Day 15 after intervention
Adverse events
Adverse events will be measured through changes in blood and urine tests and also on a self-reported basis.
Time frame: Day 60 after intervention
Nasal Obstruction
Nasal Obstruction, Sistemic medication and Endoscopy (NOSE) questionnaire. NOSE is a method of evaluating the clinical control of chronic rhinosinusitis and is based on the evaluation of three aspects: nasal obstruction, nasal endoscopy and the need for systemic medication (antibiotics or steroids). The NOSE questionnaire consists of five questions concerning subjective assessment of the nasal obstruction within the past month. Each question can be answered usinga 5-point Likert scale from"0"(not a problem) up to"4"(severe problems with breathing). After addition of allitem values and multiplying the raw score with 5, severity of the patient's complaints can be scaled to range from 0 to 100. A score of 0 indicates no obstructivenasal problems and a score of 100 implies severe problems.
Time frame: Day 45 after intervention
Nasal Obstruction
Nasal Obstruction, Sistemic medication and Endoscopy (NOSE) questionnaire. NOSE is a method of evaluating the clinical control of chronic rhinosinusitis and is based on the evaluation of three aspects: nasal obstruction, nasal endoscopy and the need for systemic medication (antibiotics or steroids). The NOSE questionnaire consists of five questions concerning subjective assessment of the nasal obstruction within the past month. Each question can be answered usinga 5-point Likert scale from"0"(not a problem) up to"4"(severe problems with breathing). After addition of allitem values and multiplying the raw score with 5, severity of the patient's complaints can be scaled to range from 0 to 100. A score of 0 indicates no obstructivenasal problems and a score of 100 implies severe problems.
Time frame: Day 90 after intervention
Nasal Endoscopic Evaluation
The nasal endoscopic evaluation will be performed under topical anesthesia, with a rigid endoscope (4mm, 0° and/or 45°; Karl Storz) and its classification will be based on the Lund - Kennedy criteria. For this evaluation, each nostril is examined separately and three possible characteristics may be present, they are: polyps, nasal mucosa edema and/or secretion. For each evaluated characteristic, a score from 0 to 2 is assigned. For the evaluation of polyps, the score is applied as follows: 0=absent; 1=restricted to the middle meatus; and, 2=extension to nasal cavity. For the evaluation of nasal mucosa edema, the score is applied as follows: 0=absent; 1=mild or moderate edema; and 2= polypoid degeneration. For the evaluation of secretion, the score is applied as follows: 0=absent; 1=hyaline secretion; and, 2=mucopurulent or thick secretion.
Time frame: Day 45 after intervention
Nasal Endoscopic Evaluation
The nasal endoscopic evaluation will be performed under topical anesthesia, with a rigid endoscope (4mm, 0° and/or 45°; Karl Storz) and its classification will be based on the Lund - Kennedy criteria. For this evaluation, each nostril is examined separately and three possible characteristics may be present, they are: polyps, nasal mucosa edema and/or secretion. For each evaluated characteristic, a score from 0 to 2 is assigned. For the evaluation of polyps, the score is applied as follows: 0=absent; 1=restricted to the middle meatus; and, 2=extension to nasal cavity. For the evaluation of nasal mucosa edema, the score is applied as follows: 0=absent; 1=mild or moderate edema; and 2= polypoid degeneration. For the evaluation of secretion, the score is applied as follows: 0=absent; 1=hyaline secretion; and, 2=mucopurulent or thick secretion.
Time frame: Day 90 after intervention
Sino Nasal Outcome Test
Sino Nasal Outcome Test (SNOT-22) The SNOT-22 Questionnaire is a modification of the SNOT-20, with 2 additional items on nasal obstruction and problems with smell and taste. The questionnaire assesses 22 items related to nasal symptoms that can impact the patient's personal and social life. Each item can get a score ranging from 0 (least possible problem) to 5 (greatest possible problem). Thus, this questionnaire has a final score that can range from 0 to 110 points. In this study, a significant clinical improvement will be considered when there is at least a variation of 11 points from one assessment to another.23 The validity and reliability of the SNOT-22 have already been previously tested in Portuguese.
Time frame: Day 45 after intervention
Sino Nasal Outcome Test
Sino Nasal Outcome Test (SNOT-22) The SNOT-22 Questionnaire is a modification of the SNOT-20, with 2 additional items on nasal obstruction and problems with smell and taste. The questionnaire assesses 22 items related to nasal symptoms that can impact the patient's personal and social life. Each item can get a score ranging from 0 (least possible problem) to 5 (greatest possible problem). Thus, this questionnaire has a final score that can range from 0 to 110 points. In this study, a significant clinical improvement will be considered when there is at least a variation of 11 points from one assessment to another.23 The validity and reliability of the SNOT-22 have already been previously tested in Portuguese.
Time frame: Day 90 after intervention
Plan to share: Undecided
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University of Sao Paulo