Thanks to the expertise and quality of our work, we have repeatedly been selected as principal investigators of international clinical trials.
A clinical trial of a new drug for COVID-19 (C5091017) is under way at the clinic. If your symptoms started no more than 2–3 days ago, or you were newly diagnosed with COVID-19 in the last 2–3 days, and you are considering taking part, call us – we will be happy to give you details.
Enlarge document
In 2017, Prim. MUDr. Pavel Navrátil, as principal investigator in the Optinose clinical trial, was inspected directly by the US Food and Drug Administration (FDA – the counterpart of the Czech SÚKL).
The FDA found no findings during the inspection and we received a commendation.
This speaks to the quality of our work, our thoroughness and our approach to patients. The same standard was confirmed by further audits in the following years (every approx. 2–3 years) – always with an excellent result.
In 2024–2025 our clinic took part in the international VIBRANT clinical trial by Upstream Bio (protocol UPB-CP-03, 7044697) for patients with chronic sinusitis with nasal polyps. The trial has ended.
In 2023–2025 our clinic took part in the international BiRCh clinical trial by Insmed (protocol INS1007-221) for patients with chronic inflammation of the paranasal sinuses without nasal polyps. The trial has ended.
Hard work and excellent results of previous clinical trials and many satisfied patients opened up access to new options for patients with chronic sinusitis. It was a clinical trial in which a small "mesh" with a precisely defined amount of drug was inserted into the nose, releasing slowly over six months and treating the symptoms of chronic sinus disease. Such treatment was not commonly available either in the Czech Republic or in Europe and was fully covered for patients.
After very good experience from previous trials, our clinic was again selected as one of the international centres for clinical research into sudden hearing loss – the AUDIOCURE study. Previously untreated patients with sudden hearing loss (ISSNHL) with onset no more than 3–4 days before treatment were enrolled. The trial took place mainly in prestigious clinics in Western Europe and the USA. In 2023 we became the national coordinator of this study for the Czech Republic.
The ReOpen2 clinical trial by OptiNose (protocol OPN-FLU-CS-3206) for patients with chronic inflammation of the paranasal sinuses without nasal polyps. Prim. MUDr. Pavel Navrátil was also the principal investigator in the previous Optinose II and III trials.
Our centre was again selected as one of the international sites for a clinical trial on sudden hearing loss – the RESTORE study.
Our clinic was selected as one of the international centres for clinical research into sudden hearing loss – the HEALOS study by Auris Medical (protocol AM-111-CL-13-01, phase 3). The trial investigated a new treatment option (AM-111) in patients with severe or profound sudden hearing loss with onset within 72 hours and took place at selected centres in Europe and Asia.
| Year | Trial / project | EudraCT |
|---|---|---|
| 1995 | Augmentin | – |
| 2007 | Optinose II | 2006-006340-60 |
| 2013 | Dizziness (vertigo) | 2007-005054-23 |
| 2014 | Optinose III | 2011-004886-34 |
| 2016 | HEALOS – Auris Medical, protocol AM-111-CL-13-01 – sudden hearing loss | 2013-002077-21 |
| 2018 | Nasal polyps | 2017-003450-16 |
| 2018 | RESTORE – Strekin, protocol STR001-202 – sudden hearing loss | 2017-000242-22 |
| 2019 | Nasal polyps | 2017-003450-16 |
| 2019 | Hearing screening of 5-year-olds (start) | – |
| 2020 | Nasal polyps | 2018-002073-22 |
| 2020 | ReOpen2 – OptiNose, protocol OPN-FLU-CS-3206 – chronic sinusitis without nasal polyps | 2019-000648-86 |
| 2021 | Antigen testing centre for COVID-19 | – |
| 2022 | Chronic sinusitis | 2019-001682-33 |
| 2022 | AUDIOCURE – sudden hearing loss | – |
| 2022 | ENLIGHTEN – chronic sinusitis | 2021-005906-83 |
| 2023 | Chronic sinusitis | 2019-000368-12 |
| 2023 | Hearing loss | 2021-004323-33 |
| 2023 | National coordinator for the Czech Republic – AUDIOCURE trial | – |
| 2023 | BiRCh – Insmed, protocol INS1007-221 – chronic sinusitis without nasal polyps | 2022-502481-24-00 |
| 2024 | VIBRANT – Upstream Bio, protocol UPB-CP-03 (7044697) – chronic sinusitis with nasal polyps | 2023-508231-31-00 |
| 2025 | ASPIRE-HR – Pfizer, protocol C5091017 – new COVID-19 drug | 2024-517727-39-00 |
| 2026 | Selected for UPB-101-NP-302 (295715) | – |
