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

Abstract

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: https://www.isrctn.com/ISRCTN14067635

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

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Citation

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

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.




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