Managing children with frequent respiratory infections and associated wheezing: a preliminary randomized study with a new multicomponent nasal spray
Main Article Content
Keywords
beta-glucans, glycyrrhetic acid, lactoferrin, medications’ use, preschoolers, respiratory infections, symptoms, vitamin C, vitamin D3, wheezing
Abstract
Background: Preschoolers frequently have respiratory infections (RIs), which may cause wheezing in some subjects. Type 2 polarization may favor increased susceptibility to RIs and associated wheezing. Non-pharmacological remedies are garnering increasing interest as possible add-on therapies. The present preliminary study investigated the efficacy and safety of a new multi-component nasal spray in preschoolers with frequent RIs and associated wheezing.
Methods: Some preschoolers with these characteristics randomly took this product, containing lactoferrin, dipotassium glycyrrhizinate, carboxymethyl-beta-glucan, and vitamins C and D3 (Saflovir), two sprays per nostril twice daily for 3 months. Other children were randomly treated only with standard therapy. Outcomes included the number of RIs and wheezing episodes, use of medications, and severity of clinical manifestations.
Results: Preschoolers treated add-on with this multicomponent product experienced fewer RIs and used fewer beta-2 agonists than untreated children (P = 0.01 and 0.029, respectively).
Conclusions: This preliminary study demonstrated that a multicomponent product, administered add-on as a nasal spray, could reduce the incidence of RIs and use of symptomatic drugs for relieving wheezing in children.
References
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2. Niederman MS, Torres A. Respiratory infections. Eur Respir Rev. 2022;31(166):220150. 10.1183/16000617.0150-2022
3. Ameli F, Brocchetti F. Mignosi S, Tosca MA, Gallo F, Ciprandi G. Recurrent respiratory infections in children: A study in clinical practice. Acta Biomed. 2020;91(4):e2020179.
4. Varricchio A, La Mantia I, Brunese FP, Ciprandi G. Inflammation, infection, and allergy of upper airways: New insights from national and real-world studies. Ital J Pediatr. 2020;46(1):18. 10.1186/s13052-020-0782-z
5. Doss AMA, Stokes JR. Viral infections and wheezing in preschool children. Immunol Allergy Clin North Am. 2022;42(4):727–41. 10.1016/j.iac.2022.05.004
6. Tenero L, Tezza G, Cattazzo E, Piacentini G. Wheezing in-preschool children. Early Hum Develop. 2013;89:S13–7. 10.1016/j.earlhumdev.2013.07.017
7. Ducharme FM, Tse SM, Chauhan B. Diagnosis, management, and prognosis of preschool wheeze. Lancet. 2014;383:1593–604. 10.1016/S0140-6736(14)60615-2
8. Makrinioti H, Hasegawa K, Lakoumentas J, Xepapadaki P, Tsolia M, Castro-Rodriguez JA, et al. The role of respiratory syncytial virus-and rhinovirus-induced bronchiolitis in recurrent wheeze and asthma—A systematic review and meta-analysis. Pediatr Allergy Immunol. 2022;33(3):e13741. 10.1111/pai.13741
9. Ciprandi G, Cioffi L, Schiavetti I, Miraglia Del Giudice M, Tosca MA. Factors associated with wheezing recurrence in clinical practice. J Asthma. 2023;60(4):843–44. 10.1080/02770903.2022.2087187
10. Ciprandi G, Tosca MA. Non-pharmacological remedies for the common cold. Minerva Pediatr (Torino). 2023;75(1):75–86. 10.23736/S2724-5276.21.06312-6
11. Giannattasio A, Poggi E, Trapani G, Muia C, Zanino L, Landi M, et al. Primary care experience on Stimunex® gocce in children with recurrent respiratory infections: A real-world study during the COVID-19 pandemic era. Allergol Immunopathol (Madr). 2022;50(3):8–14. 10.15586/aei.v50i3.562
12. Marseglia GL, Benazzo M, Biasci P, Blasi F, Cricelli C, Doria M, et al. OM-85 in the prevention of respiratory infections: State-of-the-art and future perspectives in clinical practice. J Biol Regul Homeost Agents. 2021;35(3):847–63.
13. Poggi E, Giannattasio A, Cartosio ME, Campus R, Ciprandi G. Primary care experience on Rinfodim 3® in children with recurrent respiratory infections. J Biol Regul Homeost Agents. 2020;34(6):2365–73.
14. Ciprandi G, La Mantia I, Damiani V, Passali D. Local bacteriotherapy—A promising preventive tool in recurrent respiratory infections. Expert Rev Clin Immunol. 2020;16(11):1047–52. 10.1080/1744666X.2021.1833720
15. Varricchio AM, Capasso M, Della Volpe A, Malafronte L, Mansi N, Varricchio A, et al. Resveratrol plus carboxymethyl-β-glucan in children with recurrent respiratory infections: A preliminary and real-life experience. Ital J Pediatr. 2014;40:93. 10.1186/s13052-014-0093-3
16. Varricchio A, Giuliano M, Capasso M, Del Gaizo D, Ascione E, De Lucia A, et al. Salso-sulphide thermal water in the prevention of recurrent respiratory infections in children. Int J Immunopathol Pharmacol. ,2013;26(4):941–52. , 10.1177/039463201302600412
17. Passali D, Ionescu A, Brambilla E, Bellussi LM, Ciprandi G, Mattina R, et al. Can pseudomonas aeruginosa growth be modulated by natural compounds? J Biol Regul Homeost Agents. 2021;35(1, Suppl. 2):21–5.
18. Ameli F, Ciprandi G. Sinerga may prevent recurrent respiratory infections in allergic children. J Biol Regul Homeost Agents. 2019;33:601–7.
19. Tosca MA, Del Barba P, Licari A, Ciprandi G. The measurement of asthma and allergic rhinitis control in children and adolescents. Children (Basel). 2020;7(5):43. 10.3390/children7050043
20. Wang X, Li Y, O’Brien KL, Madhi SA, Widdowson MA, Byass P, et al. Global burden of respiratory infections associated with seasonal influenza in children under 5 years in 2018: A systematic review and modelling study. Lancet Glob Health. 2020;8(4):e497–510.
21. Principi N, Esposito S. Antibiotic-related adverse events in paediatrics: Unique characteristics. Expert Opin Drug Saf. 2019;18(9):795–802. 10.1080/14740338.2019.1640678
22. Subramaniam G, Girish M. Antibiotic resistance—A cause for re-emergence of infections. Indian J Pediatr. 2020;87(11):937–44. 10.1007/s12098-019-03180-3
23. Villani L, D’Ambrosio D, Ricciardi R, De Waure C, Calabrò GE. Seasonal influenza in children: Costs for the health system and society in Europe. Influenza Other Respir Viruses. 2022;16(5):820–31. 10.1111/irv.12991
24. Sattler S. The role of the immune system beyond the fight against infection. Adv Exp Med Biol. 2017;1003:3–14. 10.1007/978-3-319-57613-8_1
25. Drago L, Cioffi L, Giuliano M, Pane M, Amoruso A, Schiavetti I. The PRObiotics in pediatric asthma management (PROPAM) study in the primary care setting: A randomized, controlled, double-blind trial with Ligilactobacillus Salivarius LS01 (DSM 22775) and Bifidobacterium Breve B632 (DSM 24706). J Immunol Res. 2022;2022:3837418. 10.1155/2022/3837418
26. Legrand D. Overview of lactoferrin as a natural immune modulator. J Pediatr. 2016;173S:S10–5. 10.1016/j.jpeds.2016.02.071
27. Dierick M, Vanrompay D, Devriendt B, Cox E. Lactoferrin, a versatile natural antimicrobial glycoprotein which modulates host innate immunity. Biochem Cell Biol. 2021;99(1):61–5. 10.1139/bcb-2020-0080
28. Sorensen M, Sorensen S. The proteins in whey. Compte rendu des Travaux du Laboratoire de Carlsberg Ser Chim. 1940;23(7):55–99.
29. Wang B, Timilsena YP, Blanch E, Adhikari B. Lactoferrin: Structure, function, denaturation and digestion. Crit Rev Food Sci Nutr. 2019;59:580–96. 10.1080/10408398.2017.1381583
30. Moreno-Exposito L, Illesca-Montes R, Meguizo-Rodriguez L, Ruiz C, Ramos-Torrecillas J, De Luna-Bertos E. Multifunctional capacity and therapeutic potential of lactoferrin. Life Sci. 2018;195:61–4. 10.1016/j.lfs.2018.01.002
31. Kell DB, Heyden EL, Pretorius E. The biology of lactoferrin, an iron-binding protein that can help defend against viruses and bacteria. Front Immunol. 2020;11:1221. 10.3389/fimmu.2020.01221
32. Lepanto MS, Rosa L, Paesano R, Valenti P, Cutone A. Lactoferrin in aseptic and septic inflammation. Molecules. 2019;24:1323. 10.3390/molecules24071323
33. Actor JK, Hwang SA, Kruzel ML. Lactoferrin as a natural immune modulator. Curr Pharm Des. 2009;15:1956–73. 10.2174/138161209788453202
34. Drago-Serrano ME, Campos-Rodríguez R, Carrero JC, De la Garza M. Lactoferrin: Balancing ups and downs of inflammation due to microbial infections. Int J Mol Sci. 2017;18:501. 10.3390/ijms18030501
35. Reyes-Cortes R, Acosta-Smith E, Mondragón-Flores R, Nazmi K, Bolscher JGM, Canizalez-Roman A. Antibacterial and cell penetrating effects of LFcin17–30, LFampin265–284, and LF chimera on enteroaggregative Escherichia coli. Biochem Cell Biol. 2017;95:76–81. 10.1139/bcb-2016-0088
36. Chen K, Jin S, Chen H, Cao Y, Dong X, Li H, et al. Dose effect of bovine lactoferrin fortification on diarrhea and respiratory tract infections in weaned infants with anemia: A randomized, controlled trial. Nutrition. 2021;90:111288. 10.1016/j.nut.2021.111288
37. Ali AS, Hasan SS, Kow CS, Merchant HA. Lactoferrin reduces the risk of respiratory tract infections: A meta-analysis of randomized controlled trials. Clin Nutr ESPEN. 2021;45:26–32. 10.1016/j.clnesp.2021.08.019
38. Vetvicka V, Vannucci L, Sima P, Richter J. Beta-glucan: Supplement or drug? From laboratory to clinical trials. Molecules. 2019;24:1251. 10.3390/molecules24071251
39. Ali MF, Driscoll CB, Walters PR, Limper AH, Carmona EM. Beta-glucan-activated human B lymphocytes participate in innate immune responses by releasing pro-inflammatory cytokines and stimulating neutrophil chemotaxis. J Immunol. 2015;195:5318–26. 10.4049/jimmunol.1500559
40. Talbott SM, Talbott JA, Talbott TL, Dingler E. Beta glucan supplementation, allergy symptoms, and quality of life in self-described ragweed allergy sufferers. Food Sci Nutr. 2013;1:90–101. 10.1002/fsn3.11
41. Ciprandi G, Bellussi LM, Passali GC, Damiani V, Passali D. HMGB1 in nasal inflammatory diseases: A reappraisal 30 years after its discovery. Exp Rev Clin Immunol. 2020;16:457–63. 10.1080/1744666X.2020.1752668
42. Bellussi LM, Cocca S, Passali GC, Passali D. HMGB1 in the pathogenesis of nasal inflammatory diseases and its inhibition as a new therapeutic approach: A review from the literature. Int Arch Otorhinolaryngol. 2017;21:390–8. 10.1055/s-0036-1597665
43. Hemila H. Vitamin C and infections. Nutrients. 2017;9:339. 10.3390/nu9040339
44. Webb AL, Villamor E. Update: Effects of antioxidant and non-antioxidant vitamin supplementation on immune function. Nutr Rev. 2007;65:181–217. 10.1111/j.1753-4887.2007.tb00298.x
45. Sassi F, Tamone C, D’Amelio P. Vitamin D: Nutrient, hormone, and immunomodulator. Nutrients. 2018;10:1656. 10.3390/nu10111656
46. Holick MF. Vitamin D deficiency. New Engl J Med. 2007;357:266–81. 10.1056/NEJMra070553
47. Camargo CA Jr, Ingham T, Wickens K, Thadhani R, Silvers KM, Epton MJ. Cord-blood 25-hydroxyvitamin D levels and risk of respiratory infection, wheezing, and asthma. Pediatrics. 2011;127:180–7. 10.1542/peds.2010-0442
48. Saggese G. Vitamin D in pediatric age: Consensus of the Italian Pediatric Society and the Italian Society of Preventive and Social Pediatrics, jointly with the Italian Federation of Pediatricians. Ital J Pediatr. 2018;44:51. 10.1186/s13052-018-0488-7
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May 1, 2024
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Tosca, M. A., Varricchio, A., Schiavetti, I., Naso, M., Damiani, V., & Ciprandi, G. (2024). Managing children with frequent respiratory infections and associated wheezing: a preliminary randomized study with a new multicomponent nasal spray. Allergologia Et Immunopathologia, 52(3), 22-30. https://doi.org/10.15586/aei.v52i3.1040
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How to Cite
Tosca, M. A., Varricchio, A., Schiavetti, I., Naso, M., Damiani, V., & Ciprandi, G. (2024). Managing children with frequent respiratory infections and associated wheezing: a preliminary randomized study with a new multicomponent nasal spray. Allergologia Et Immunopathologia, 52(3), 22-30. https://doi.org/10.15586/aei.v52i3.1040