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

Study type

• Study topic:
  Disease /health condition

  Herbal medicinal product

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Evaluation of patient-reported outcomes

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective RWD study -> online Patient survey (e-Diary up to 14 days) using PROMs

Study drug and medical condition

• Medicinal product name, other:
  Sinupret® extract, comprising a dry extract of gentian root (Gentiana lutea L.), primula flower (Primula veris L.), sorrel herb (Rumex crispus L.), elder flower (Sambucus nigra L.), and verbena herb (Verbena officinalis L.)
• Anatomical Therapeutic Chemical (ATC) code:
  (R05X) OTHER COLD PREPARATIONS

  OTHER COLD PREPARATIONS
• Additional medical condition(s):
  Acute Rhinosinusitis

Population studied

• Short description of the study population:
  At least 5,000 patients are planned to be enrolled.; Patients eligible for study participation should meet the following inclusion criteria:; • Symptoms suggestive of ARS, which means sudden onset of 2 or more symptoms, one of which should be either nasal blockage / obstruction / congestion or nasal discharge (anterior/posterior nasal drip); o ± facial pain/pressure; o ± reduction or loss of smell; • Age ≥12 years
• Age groups:
  • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  5000

Study design details

• Study design:
  Prospective RWD study -> online Patient survey (eDiary up to 14 days) using PROMs
• Main study objective:
  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).
• Setting:
  The field phase of the study is expected to range from October 2024 until May 2025.; Each eligible patient will be followed-up daily for 14 days.; ; Please see information regarding study treatment below "Comparators".
• Comparators:
  “Study treatment” is chosen by the participating patient (or prescribed by attending physician, if applicable) and may consist of SinX monotherapy or in combination with other cold medications, other cold medications only, or even no treatment. ; All treatments should follow the instructions provided in the package leaflets of the respective drugs or the prescription made by the attending physician.
• Outcomes:
  Patient-reported outcome measures (PROMs):; - MSSPAT and most bothersome MSS symptom; - Numerical rating scale (NRS) for bothersomeness of symptoms; - SNOT-20 GAV and 5 most important/bothersome items; - SNOT-16 (ARS) incl. 5 most important/bothersome items (in a subgroup of patients only); - Overall assessment of effectiveness; - Overall assessment of tolerability; - Overall satisfaction with treatment
• Data analysis plan:
  According to the non-interventional character of the study, the statistical analysis is descriptive and explorative. ; No statistical hypotheses are postulated, and thus no inferential tests are planned.
• Summary results:
  not yet available