A Controlled, Randomized Clinical Study to Verify the Efficacy and Safety of a New Hypertonic Solution (Narlisim) in Nasal Congestion in Adults Affected by Common Cold
Authors/Creators
- 1. Department of Sense Organs, Sapienza University of Rome, Italy
- 2. ENT Department, Lamezia Terme Hospital, Italy
Description
Background: Nasal congestion is the main symptom of common cold. Symptomatic treatment with nasal decongestant seems to be the only treatment option. We conducted a study to assess the efficacy of Narlisim, a newly developed nasal spray, on nasal congestions in common cold. Materials and methods: Sixty adult patients with common cold were included in the study. Thirty patients were treated with Narlisim nasal spray, and 30 patients with isotonic nasal spray. The primary outcome was the assessment of the speed of relief of nasal congestion; the secondary outcome was the assessment of nasal congestion and nasal secretion symptoms by a 0–100% rating Visual analog score (VAS) scale on 5 items at baseline and after 5, 10, 15, 20, 25 and 30 minutes from treatment. Results: The study group experienced a faster relief of nasal congestion compared to the controlgroup151.1 vs 246.8 seconds). VAS score progressively reduced for all investigated symptoms in both groups; a statistically significant higher mean reduction at each time point was recorded in the study group compared to controls (p<0.001). Conclusions: Our results suggest that Narlisim may be a promising medical device to control nasal congestion and rhinitis in common cold thanks to its nasal washing, hypertonic city, and low pH and osmo protection properties.
Files
(6-11)A controlled, randomized clinical study to verify the efficacy-format.pdf
Files
(749.1 kB)
| Name | Size | Download all |
|---|---|---|
|
md5:c34fdaeb363665730de0d8a4b1a79a84
|
749.1 kB | Preview Download |
Additional details
References
- Eccles R., Eriksson M., Garreffa S. & Chen S.C. The nasal decongestant effect of xylometazoline in the common cold. Am J Rhinol. 2008 Sep-Oct; 22(5): pp. 491-6. Doi: 10.2500/ajr.2008.22.3202. Epub 2008 Jul 24.
- Fendrick A.M., Monto A.S., Nightengale B. & Sarnes M. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Arch Intern Med. 2003; 163(4): pp. 487–94.
- Adam P., Stiffman M. & Blake RL Jr. A clinical trial of hypertonic saline nasal spray in subjects with the common cold or rhinosinusitis. Arch Fam Med. 1998 Jan-Feb; 7(1): pp. 39-43.
- Van Driel M.L., Scheire S., Deckx L., Gevaert P. & De Sutter A. What treatments are effective for common cold in adults and children? BMJ. 2018 Oct 10; 363: pp. k3786. Doi: 10.1136/bmj.k3786.
- Allan G.M. & Arroll B. Prevention and treatment of the common cold: making sense of the evidence. CMAJ. 2014 Feb 18; 186(3): pp. 190-9. Doi: 10.1503/cmaj.121442. Epub 2014 Jan 27. DOI: 10.1503/cmaj.121442
- Mösges R., Shah-Hosseini K., Hucke H.P. & Joisten M.J. Dexpanthenol: An Overview of its Contribution to Symptom Relief in Acute Rhinitis Treated with Decongestant Nasal Sprays. Adv Ther. 2017 Aug; 34(8): pp. 1850-1858. Doi: 10.1007/s12325-017-0581-0. Epub 2017 Jul 10.
- Mehuys E., Gevaert P., Brusselle G. et al. Self-medication in persistent rhinitis: overuse of decongestants in half of the patients. J Allergy Clin Immunol Pract. 2014; 2: pp. 313-9. 10.1016/j.jaip.2014.01.009. 10.1016/j.jaip.2014.01.009 24811023
- Fashner J., Ericson K. & Werner S. Treatment of the common cold in children and adults. Am Fam Physician. 2012 Jul 15; 86(2): pp. 153-9.
- Chong L.Y., Head K., Hopkins C., Philpott C., Glew S., Scadding G., Burton M.J. & Schilder A.G. Saline irrigation for chronic rhinosinusitis. Cochrane Database Syst Rev. 2016 Apr 26; 4: pp. CD011995. Doi: 10.1002/14651858.CD011995.pub2
- Rennie P., Bowtell P., Hull D., Charbonneau D. & Lambkin-Williams R., Oxford J. Low pH gel intranasal sprays inactivate influenza viruses in vitro and protect ferrets against influenza infection. Respir Res. 2007 May 17; 8: pp. 38.