The real-world “ControL’Asma” study: a nationwide taskforce on asthma control in children and adolescents

Main Article Content

Maria Angela Tosca
Gian Luigi Marseglia
Giorgio Ciprandi
ControL’Asma” Study Group

Keywords

asthma, asthma control, children, adolescents, visual analog scale (VAS), respiratory symptoms, lung function

Abstract

Background: Asthma control is the goal of asthma management. A nationwide study on this aspect was launched by the Italian Society of Paediatric Allergy and Immunology (ControL’Asma study).


Objective: To define variables associated with different asthma control grades in a nationwide population of asthmatic children and adolescents.


Methods: This cross-sectional real-world study included 480 asthmatic children and adolescents (333 males, median age 11.2 years) consecutively enrolled in 10 third level pediatric allergy clinics. According to the Global Initiative for Asthma (GINA) document, history, medication use, perception of asthma symptoms assessed by visual analog scale (VAS), clinical examination, lung function, childhood asthma control test (cACT)/asthma control test (ACT), and asthma control level were evaluated.


Results: Considering GINA criteria, asthma was well controlled in 55% of patients, partly controlled in 32.4%, and uncontrolled in 12.6%. Regarding cACT/ACT, asthma was uncontrolled in 23.2%. Patients with uncontrolled asthma had the lowest lung function parameters and VAS scores, more frequent bronchial obstruction and reversibility, and used more oral and inhaled corticosteroids (CS).


Conclusions: The ControL’Asma study, performed in a real-world setting, showed that asthma in Italian children and adolescents was usually more frequent in males. Asthmatic patients had an early onset and allergic phenotype with very frequent rhinitis comorbidity. Uncontrolled and partly controlled asthma affected about half of the subjects, and the assessment of asthma symptom perception by VAS could be a reliable tool in asthma management.

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References

1. Global Initiative for Asthma. Global strategy for asthma management and prevention, 2019. Available from: www.ginasthma.org

2. Chipps BE, Bacharier LB, Farrar JR, Jackson DJ, Murphy KR, Phipatanakul W, et al. The pediatric asthma yardstick. Ann Allergy Asthma Immunol. 2018;120:559–579. 10.1016/j.anai.2018.04.002

3. Akar-Ghibril N, Casale T, Custovic A, Phipatanakul W. Allergic endotypes and phenotypes of asthma. J Allergy Clin Immunol Pract. 2020;8:429–440. 10.1016/j.jaip.2019.11.008

4. Di Cicco M, D’Elios S, Peroni DG, Comberiati P. The role of atopy in asthma development and persistence. Curr Opin Allergy Clin Immunol. 2020 (in press). 10.1097/ACI.0000000000000627

5. British Thoracic Society; Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma. Thorax. 2014;69 Suppl 1:1–192.

6. Australia NAC. Australian asthma handbook. Melbourne: National Asthma Council Australia; 2017. V1.3: https://www.asthmahandbook.org.au

7. Excellence NIfHaC. Asthma: diagnosis, monitoring and chronic asthma management. https://www.nice.org.uk

8. Zahran HS, Bailey CM, Qin X, Johnson C. Long-term control medication use and asthma control status among children and adults with asthma. J Asthma. 2017;54:1065–1072. 10.1080/02770903.2017.1290105

9. Bloomberg GR, Banister C, Sterkel R, Epstein J, Bruns J, Swerczek L, et al. Socioeconomic, family, and pediatric practice factors that affect level of asthma control. Pediatrics. 2009;123:829–835. 10.1542/peds.2008-0504

10. Bårnes CB, Ulrik CS. Asthma and adherence to inhaled corticosteroids: current status and future perspectives. Respir Care. 2015;60:455–468 . 10.4187/respcare.03200

11. Engelkes M, Janssens HM, de Jongste JC, Sturkenboom MC, Verhamme KM. Medication adherence and the risk of severe asthma exacerbations: a systematic review. Eur Respir J. 2015;45:396–407. 10.1183/09031936.00075614

12. Reddel HK, Taylor R, Bateman ED, Boulet LP, Boushey HA, Busse WW, et al. An official American Thoracic Society/European Respiratory Society Statement: asthma control and exacerbations. Am J Respir Crit Care Med. 2009;180:59–99. 10.1164/rccm.200801-060ST

13. Virchow JC, Backer V, de Blay F, Kuna P, Ljorring C, Prieto J, et al. Defining moderate asthma exacerbations in clinical trials based on ATS/ERS joint statement. Resp Med. 2015;109:547–556. 10.1016/j.rmed.2015.01.012

14. Williams SA, Wagner S, Kannan H, Bolge SC. The association between asthma control and healthcare utilization, work productivity loss, and health-related quality of life. J Occup Environ Med. 2009;51:780–785. 10.1097/JOM.0b013e3181abb019

15. Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, et al. Interpretative strategies for lung function tests. Eur Respir J. 2005;26:948–968. 10.1183/09031936.05.00035205

16. Miller MR, Hankinson J, Brusasco V, Burgos R, Casaburi R, Coates R, et al. Standardisation of spirometry. Eur Respir J. 2005;26:319–338. 10.1183/09031936.05.00034805

17. Tosca MA, Silvestri M, Olcese R, Pistorio A, Rossi GA, Ciprandi G. Breathlessness perception assessed by visual analogue scale and lung function in children with asthma: a real-life study. Ped Allergy Immunol. 2012;23:537–542. 10.1111/j.1399-3038.2012.01316.x

18. Use of real-world evidence to support regulatory decision-making for medical devices. Guidance for industry and Food and Drug Administration staff document issued on August 31, 2017. Bethesda: US Food and Drug Administration, US Department of Health and Human Services Food and Drug Administration, Center for Devices and Radiological Health Center for Biologics Evaluation and Research; 2017.

19. Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, et al. Real-world evidence-what is it and what can it tell us? N Engl J Med. 2016;375:2293–2297. 10.1056/NEJMsb1609216

20. Milger K, Korn S, Buhl R, Hamelmann E, Herth FJF, Gappa M, et al. Age-and sex-dependent differences in patients with severe asthma included in the German asthma net cohort. Resp Med. 2020;162:105858. 10.1016/j.rmed.2019.105858

21. Ciprandi G, Gallo F. The impact of gender on asthma in the daily practice. Postgrad Med. 2018;130:271–273. 10.1080/00325481.2018.1430447

22. Tosca MA, Silvestri M, Olcese R, Pistorio A, Rossi GA, Ciprandi G. Breathlessness perception assessed by visual analogue scale and lung function in children with asthma: a real-life study. Ped Allergy Immunol. 2012;23:537–542. 10.1111/j.1399-3038.2012.01316.x

23. Tosca MA, Silvestri M, Rossi GA, Ciprandi G. Perception of bronchodilation assessed by Visual Analogue Scale in children with asthma. Allergol Immunopathol. 2013;41:359–363. 10.1016/j.aller.2012.06.002

24. Bousquet J, Anto JM, Bachert C, Bosnic-Anticevich S, Erhola E, Haahtela T, et al. From ARIA guidelines to the digital transformation of health in rhinitis and asthma multimorbidity. Eur Respir J. 2019;54:1901023. 10.1183/13993003.01023-2019

25. Brew BK, Chiesa F, Lundholm C, Ortqvist A, Almqvist C. A modern approach to identifying and characterizing child asthma and wheeze phenotypes based on clinical data. PLoS One. 2019;14:e0227091. 10.1371/journal.pone.0227091

26. Kaplan A, Price D. Treatment adherence in adolescents with asthma. J Asthma Allergy. 2020;13:39–49. 10.2147/JAA.S233268

27. Hoch de Keyser H, Ramsey R, Federico MJ. They just don’t take their medicine: reframing medication adherence in asthma from frustration to opportunity. Pediatr Pulmonol. 2020;55:818–825. 10.1002/ppul.24643

28. Weinberger SJ, Cowan KJ, Robinson KJ, Pellegrino CA, Frankowski BL, Chmielewski MV, et al. A primary care learning collaborative to improve office systems and clinical management of pediatric asthma. J Asthma. 2020 (in press). 10.1080/02770903.2019.1702199

29. Ciprandi G, Gallo F, Ricciardolo F. A real-life comparison between Asthma Control Test and GINA asthma control grading. Annals Allergy Asthma Immunol. 2016;117:725–727. 10.1016/j.anai.2016.09.442