Acta Scientific Otolaryngology (ASOL) (ISSN: 2582-5550)

Research Article Volume 4 Issue 2

Safety and Efficacy Assessment of Stérimar Stop and Protect Cold for Adults and Stérimar Blocked Nose in Common Cold: A Randomized, Double-blind, Controlled Parallel-group, Clinical Study

Federica Sbrocca1, Amina Saaid2 and Josip Culig3*

1Opera CRO, TIGERMED Group Company, Genova, Italia
2Department of R&D and Innovation, Laboratoire Fumouze, Levallois-Perret, France
3Department of Internal Medicine and Clinical Pharmacology, University of Applied Health Sciences, Zagreb, Croatia

*Corresponding Author: Josip Culig, Department of Internal Medicine and Clinical Pharmacology, University of Applied Health Sciences, Zagreb, Croatia.

Received: November 24, 2021; Published: December 09, 2021


Background: Current treatment options for common cold focus on symptomatic relief. Nasal irrigation is a safe, inexpensive and effective adjunct treatment to reduce common cold-associated nasal congestion; it also improves quality of life and decreases medication use.

Purpose: The objective of this work was to investigate safety and efficacy of a novel microfiltered hypertonic seawater solution enriched with hyaluronic acids, eucalyptus oil and copper salts (SSPCA) on relieving common cold symptoms in comparison to a hypertonic seawater solution enriched with copper salts only (SBN).

Methods: In total, 102 common cold patients were randomized to use SSPCA (n = 51) or SBN (n = 51) until their common cold episode was resolved (maximum 14 days). Illness severity evaluated by means of the validated 21-item Wisconsin Upper Respiratory Symptom Survey (WURSS-21) was the primary endpoint. Illness duration, use of rescue medication, patient satisfaction and acceptability were secondary endpoints measured through patient diaries. In addition, nasal presence of 24 airway pathogens was screened via RT-PCR before and after treatment.

Results: Based on subjective patient diaries, SSPCA was as effective as SBN in reducing overall illness/symptom severity, improving quality of life and satisfying patient expectations. SSPCA had a faster onset of action than SBN in nasal decongestion (p = 0.0056), symptom and breathing relief (p = 0.0028 and p = 0.0128, respectively), stopping cold symptoms (p = 0.0002), and improving nasal well-being (p = 0.0279). Amount of airway pathogens - including rhino- and adenoviruses - was significantly lower after the treatment compared to pre-treatment, with no difference between groups. No adverse events were reported.

Conclusion: Both SSPCA and SBN appear to be safe and effective solutions that enable symptomatic relief and decrease the presence of nasal viruses in common cold patients. However, SSPCA had a faster onset of action compared to SBN in nasal decongestion and breathing relief, improving common cold symptoms and nasal well-being.

Trial registration: ISRCTN, ISRCTN14067635 (retrospectively registered). Available at:

Keywords: Nasal Irrigation; Common Cold; Hypertonic Solutions; Seawater; Hyaluronic Acid; Copper


  1. Passioti M., et al. “The common cold: potential for future prevention or cure”. Current Allergy and Asthma Reports 14 (2014): 413.
  2. Dicpinigaitis PV., et al. “Impact of cough and common cold on productivity, absenteeism, and daily life in the United States: ACHOO Survey”. Current Medical Research and Opinion 31 (2015): 1519-1525.
  3. Allan GM and Arroll B. “Prevention and treatment of the common cold: making sense of the evidence”. CMAJ 186 (2014): 190-199.
  4. Lewis-Rogers N., et al. “Human rhinovirus diversity and evolution: how strange the change from major to minor”. Journal of Virology 7 (2017).
  5. Arroll B. “Common cold”. BMJ Clinical Evidence3 (2011): 1510-1534.
  6. Fashner J., et al. “Treatment of the common cold in children and adults”. American Family Physician 86 (2012): 153-159.
  7. Ao H., et al. “Efficacy and mechanism of nasal irrigation with a hand pump against influenza and non-Influenza viral upper respiratory tract infection”. Journal of Infectious Diseases and Immunity 3 (2011): 96-105.
  8. Papsin B and McTavish A. “Saline nasal irrigation: Its role as an adjunct treatment”. Canadian Family Physician 49 (2003): 168-173.
  9. Rabago D., et al. “The prescribing patterns of Wisconsin family physicians surrounding saline nasal irrigation for upper respiratory conditions”. WMJ 108 (2009): 145.
  10. Heatley DG., et al. “Nasal irrigation for the alleviation of sinonasal symptoms”. Otolaryngology–Head and Neck Surgery 125 (2001): 44-48.
  11. Slapak I., et al. “Efficacy of isotonic nasal wash (seawater) in the treatment and prevention of rhinitis in children”. Archives of Otolaryngology--Head and Neck Surgery 134 (2008): 67-74.
  12. Rabago D., et al. “Efficacy of daily hypertonic saline nasal irrigation among patients with sinusitis: a randomized controlled trial”. Journal of Family Practice 12 (2002): 1049-1055.
  13. Shoseyov D., et al. “Treatment with hypertonic saline versus normal saline nasal wash of pediatric chronic sinusitis”. Journal of Allergy and Clinical Immunology 101 (1998): 602-605.
  14. Robinson M., et al. “Effect of increasing doses of hypertonic saline on mucociliary clearance in patients with cystic fibrosis”. Thorax 52 (1997): 900-903.
  15. Culig J., et al. “Efficiency of hypertonic and isotonic seawater solutions in chronic rhinosinusitis”. MED Glas 7 (2010): 116-123.
  16. Jackson GG., et al. “Present concepts of the common cold”. American Journal of Public Health and the Nation's Health 52 (1962): 940-945.
  17. Heikkinen T., et al. “The common cold”. Lancet 361 (2003): 51-59.
  18. Bernstein JA., et al. “A randomized, double-blind, parallel trial comparing capsaicin nasal spray with placebo in subjects with a significant component of nonallergic rhinitis”. Annals of Allergy, Asthma and Immunology 107 (2011): 171-178.
  19. King D., et al. “Saline nasal irrigation for acute upper respiratory tract infections”. Cochrane Database System Review 4 (2015): CD006821.
  20. Talbot AR., et al. “Mucociliary clearance and buffered hypertonic saline solution”. Laryngoscope 107 (1997): 500-503.
  21. Prosdocimi M and Bevilacqua C. “Exogenous hyaluronic acid and wound healing: an updated vision”. Panminerva Medicine 54 (2012): 129-135.
  22. Gouteva I., et al. “Clinical efficacy of a spray containing hyaluronic acid and dexpanthenol after surgery in the nasal cavity (septoplasty, simple ethmoid sinus surgery, and turbinate surgery)”. Journal of Allergy (Cairo) 2014 (2014): 635490.
  23. Salari MH., et al. “Antibacterial effects of Eucalyptus globulus leaf extract on pathogenic bacteria isolated from specimens of patients with respiratory tract disorders”. Clinical Microbiology and Infection 12 (2006): 194-196.
  24. Behrendt HJ., et al. “Characterization of the mouse cold‐menthol receptor TRPM8 and vanilloid receptor type‐1 VR1 using a fluorometric imaging plate reader (FLIPR) assay”. British Journal of Pharmacology 141 (2004): 737-745.
  25. Borkow G and Gabbay J. “Copper as a biocidal tool”. Current Medicinal Chemistry 12 (2005): 2163-2175.
  26. Brophy MB and Nolan EM. “Manganese and microbial pathogenesis: sequestration by the Mammalian immune system and utilization by microorganisms”. ACS Chemical Biology 10 (2015): 641-651.
  27. Huang S., et al. “Efficacy of a seawater solution enriched with copper, hyaluronic acid and eucalyptus against nasal pathogens”. Rhinology Online 2 (2019): 119-124.
  28. Van Doremalen N., et al. “Aerosol and surface stability of SARS-CoV-2 as compared with SARS-CoV-1”. The New England Journal of Medicine 382 (2020): 1564-1567.
  29. Radulesco T., et al. “Copper enhanced nasal saline irrigations: a safe potential treatment and protective factor for COVID-19 infection?”. Rhinology Online 3 (2020): 87-88.
  30. Contencin P. “Utilisation des solutions enrichies de Stérimar® en pratique ORL chez l'enfant”. Pediatric Review: International 298 (1999): 38-40.


Citation: Josip Culig., et al. “Safety and Efficacy Assessment of Stérimar Stop and Protect Cold for Adults and Stérimar Blocked Nose in Common Cold: A Randomized, Double-blind, Controlled Parallel-group, Clinical Study". Acta Scientific Otolaryngology 4.2 (2022): 07-17.


Copyright: © 2022 Josip Culig., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


Acceptance rate34%
Acceptance to publication20-30 days
Impact Factor0.871

Indexed In

News and Events

  • Certification for Review
    Acta Scientific certifies the Editors/reviewers for their review done towards the assigned articles of the respective journals.
  • Submission Timeline for Upcoming Issue
    The last date for submission of articles for regular Issues is May 30, 2024.
  • Publication Certificate
    Authors will be issued a "Publication Certificate" as a mark of appreciation for publishing their work.
  • Best Article of the Issue
    The Editors will elect one Best Article after each issue release. The authors of this article will be provided with a certificate of "Best Article of the Issue"
  • Welcoming Article Submission
    Acta Scientific delightfully welcomes active researchers for submission of articles towards the upcoming issue of respective journals.

Contact US