Prospective, virtual, real-world data study in adults and adolescents ≥12 years with symptoms suggestive of acute rhinosinusitis (SinARv)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000526
• Study ID:
  1000000526
• Official title and acronym:
  Prospective, virtual, real-world data study in adults and adolescents ≥12 years with symptoms suggestive of acute rhinosinusitis (SinARv)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The objective of the study is to collect real-world evidence and safety data for SinX in monotherapy and combination therapy, and to gain further insights into symptoms suggestive of acute rhinosinusitis (ARS), in adults and adolescents ≥12 years, using patient-reported outcome measures (PROMs).
• Study status:
  Finalised

Research institutions and networks

Institutions

Bionorica SE

Germany

Study timelines

Date when funding contract was signed

Planned:06/08/2024

Actual:06/08/2024

Study start date

Planned:31/10/2024

Actual:18/11/2024

Data analysis start date

Planned:24/01/2025

Actual:24/01/2025

Date of interim report, if expected

Planned:31/01/2025

Actual:31/01/2025

Date of final study report

Planned:19/12/2025

Actual:31/10/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bionorica SE

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable