Rhinosinusitis ChronicPhase 3NCT05450471
Effectiveness of Endonasal Polymeric Implant for Chronic Rhinosinusitis
A Phase 3 study testing Corticosteroid Topical in people with Rhinosinusitis Chronic, run by University of Sao Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinosinusitis Chronic
- What is being tested?
- Corticosteroid Topical
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Aug 2021to 15 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Luiz Eduardo Flório Junior
São Paulo, São Paulo
Luiz Eduardo Flório Junior, MD, 55 15 98108-0412, luiz-florio@hotmail.com
About this study
Official title: Effectiveness of Endonasal Polymeric Implant in the Treatment of Chronic Eosinophilic and Central Compartment Rhinosinusitis: a Randomized Controlled Trial
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
- Being tested
- Corticosteroid Topical, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corticosteroid TopicalDrug
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.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| L-lactide and trimethynele carbonate Terpolymers polymer implant | Experimental | 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. Receives: Drug: Corticosteroid Topical |
| Placebo polymer implant | Placebo comparator | Placebo polymer implant Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 15 after intervention
Secondary outcomes (23)
Morning serum level of cortisol, albumin and serum globulin
blood test
Measured: Day 15 after intervention
Morning serum level of cortisol, albumin and serum globulin
blood test
Measured: Day 60 after intervention
ACTH - adrenocorticotropic hormone
blood test
Measured: Day 15 and 60 aftern intervention
ACTH - adrenocorticotropic hormone
blood test
Measured: 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
Measured: Day 60 after intervention
total and serum IgE (blood test)
blood test
Measured: Day 15 after intervention
total and serum IgE (blood test)
blood test
Measured: Day 60 after intervention
Cortisol level in 24-hour urine
urine test
Measured: Day 15 after intervention
Cortisol level in 24-hour urine
urine test
Measured: Day 60 after intervention
Intraocular pressure profile - IOP
ophthalmologic assessment - fluid overload test and the lens by slit lamp examination
Measured: Day 15 after intervention
Intraocular pressure profile - IOP
ophthalmologic assessment - fluid overload test and the lens by slit lamp examination
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 90 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start20 Aug 2021
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinosinusitis ChronicStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Eduardo Florio Junior, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450471
- Sponsor's protocol ID
- USPStudy
- Status last verified
- Jul 2022
- First submitted
- 14 Jan 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Endonasal Polymeric Implant in the Treatment of Chronic Eosinophilic and Central Compartment Rhinosinusitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05450471
- Acronym / sponsor ID
- USPStudy
- Conditions
- Rhinosinusitis Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Dec 2022 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-lactide and trimethynele carbonate Terpolymers polymer implant | Experimental | Drug: Corticosteroid TopicalThe 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. |
| Placebo polymer implant | Placebo comparator | Other: PlaceboPlacebo polymer implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corticosteroid TopicalThe 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. | Drug | L-lactide and trimethynele carbonate Terpolymers polymer implant |
| PlaceboPlacebo | Other | Placebo polymer implant |
Primary outcome
Nasal Obstruction
Time frame: Day 15 after intervention
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.
Nasal Endoscopic Evaluation
Time frame: Day 15 after intervention
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.
Sino Nasal Outcome Test
Time frame: Day 15 after intervention
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.
23 secondary outcomes
Morning serum level of cortisol, albumin and serum globulin
Time frame: Day 15 after intervention
Morning serum level of cortisol, albumin and serum globulin
Time frame: Day 60 after intervention
ACTH - adrenocorticotropic hormone
Time frame: Day 15 and 60 aftern intervention
ACTH - adrenocorticotropic hormone
Time frame: Day 15 after intervention
Complete blood count
Time frame: Day 60 after intervention
total and serum IgE (blood test)
Time frame: Day 15 after intervention
total and serum IgE (blood test)
Time frame: Day 60 after intervention
Cortisol level in 24-hour urine
Time frame: Day 15 after intervention
Cortisol level in 24-hour urine
Time frame: Day 60 after intervention
Intraocular pressure profile - IOP
Time frame: Day 15 after intervention
Intraocular pressure profile - IOP
Time frame: Day 60 after intervention
Patient comfort
Time frame: Day 15 after intervention
Patient comfort
Time frame: Day 60 after intervention
Patient self-reported perception of improvement and satisfaction with the implant
Time frame: Day 15 after intervention
Patient self-reported perception of improvement and satisfaction with the implant
Time frame: Day 60 after intervention
Adverse events
Time frame: Day 15 after intervention
Adverse events
Time frame: Day 60 after intervention
Nasal Obstruction
Time frame: Day 45 after intervention
Nasal Obstruction
Time frame: Day 90 after intervention
Nasal Endoscopic Evaluation
Time frame: Day 45 after intervention
Nasal Endoscopic Evaluation
Time frame: Day 90 after intervention
Sino Nasal Outcome Test
Time frame: Day 45 after intervention
Sino Nasal Outcome Test
Time frame: Day 90 after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Corticosteroid Topical in people with Rhinosinusitis Chronic, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Obstruction (time frame: Day 15 after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.