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NCT05450471
Effectiveness of Endonasal Polymeric Implant for Chronic Rhinosinusitis
Phase 3 trial testing Corticosteroid Topical in Rhinosinusitis Chronic in 36 participants. Status unknown.
15 July 2022
Quick facts
| Lead sponsor | University of Sao Paulo |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 20 August 2021 |
| Primary completion | 15 July 2022 |
| Estimated completion | 15 December 2022 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Corticosteroid Topical — full drug profile →
- Placebo
Conditions studied
- Rhinosinusitis Chronic — all drugs for Rhinosinusitis Chronic →
Sponsor
University of Sao Paulo
Who can join
18 and older, any sex, with Rhinosinusitis Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT05450471
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05450471 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo
- Last refreshed: 8 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05450471.
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