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Effectiveness of inhaled corticosteroids and long-acting β-agonists combinations in real clinical practice: results of a multicenter cross-sectional study in Russian patients with asthma

https://doi.org/10.18093/0869-0189-2021-31-5-613-626

Abstract

Asthma management approaches are improving yearly, but the problem of asthma control is still acute. Combinations of inhaled glucocorticosteroids (ICS) and long-acting β2-agonists (LABA) play a crucial role in asthma therapy, but their effectiveness in real practice can be insufficient, and asthma control level in the population remains low. Optimizing the use of these drugs, changing the usual therapy regimens, and implementing upgraded inhalers can improve adherence to treatment and inhalation technique, which affects the effectiveness of the therapy.

The study aimed to describe the key characteristics of the patient population getting asthma treatment in real clinical practice and assess factors influencing asthma control, including adherence to therapy.

Methods. A single-stage cross-sectional observational study in 124 primary health care centers in 22 cities of the Russian Federation included 3,214 patients > 18 years old, with a clinical diagnosis of asthma for at least 1 year, who were able to perform a spirometry test and fill out the ACQ-5 and TAI-12 questionnaires.

Results. Assessment of asthma control with the ACQ-5 questionnaire showed that most patients had uncontrolled asthma (56%). Controlled and partially controlled asthma was diagnosed in 21 and 19% of patients, respectively. 4% of patients had severe uncontrolled asthma. The TAI questionnaire revealed low adherence to therapy in more than half of the patients (53.6%). The rate of patients with controlled asthma and the average annual frequency of exacerbations were significantly lower in subgroups of patients who received therapy with extrafine ICS/LABA and ICS/formoterol in single inhaler regimen, compared with controller therapy using fixed and free combinations of ICS and LABA.

Conclusion. The main causes of insufficient asthma control are low adherence to treatment, inhalation errors, monotherapy with ICS, asthma with small airways dysfunction, and adverse events associated with ICS. Prescribing the combinations of ICS/LABA in the form of extra-fine aerosol and using it in the Maintenance and Reliever Therapy (MART) regimen can significantly increase asthma control, reduce the risk of adverse events, and increase patient adherence to treatment. A potential alternative to improve asthma control is administering ICS-LABA combinations once daily.

About the Authors

Vladimir V. Arkhipov
Russian Medical Academy of Continuous Professional Education, Healthcare Ministry
Russian Federation

Vladimir V. Arkhipov, Doctor of Medicine, Professor, Department of Clinical Pharmacology and Therapy

ul. Barrikadnaya 2/1, build. 1, Moscow, 123995

tel.: (499) 252-21-04


Competing Interests:

Arkhipov V.V. reports lecturing for AstraZeneca, Bayer AG, Boehringer Ingelheim, Chiesi Pharmaceuticals LLC, GlaxoSmithKline, Merck&Co, Novartis, TEVA, Zambon Pharma. Aisanov Z.R. – Writing articles and giving lectures for Chiesi Pharmaceuticals LLC. Avdeev S.N. – Writing articles and giving lectures for Chiesi Pharmaceuticals LLC.



Zaurbek R. Aisanov
Pirogov Russian National Research Medical University (Pirogov Medical University), Healthcare Ministry
Russian Federation

Zaurbek R. Aisanov, Doctor of Medicine, Professor, Department of Pulmonology

ul. Ostrovityanova 1, Moscow, 117997

tel.: (495) 965-34-66


Competing Interests:

Arkhipov V.V. reports lecturing for AstraZeneca, Bayer AG, Boehringer Ingelheim, Chiesi Pharmaceuticals LLC, GlaxoSmithKline, Merck&Co, Novartis, TEVA, Zambon Pharma. Aisanov Z.R. – Writing articles and giving lectures for Chiesi Pharmaceuticals LLC. Avdeev S.N. – Writing articles and giving lectures for Chiesi Pharmaceuticals LLC.



Sergey N. Avdeev
Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Healthcare; Federal Pulmonology Research Institute, Federal Medical and Biological Agency
Russian Federation

Sergey N. Avdeev, Doctor of Medicine, Professor, Corresponding Member of Russian Academy of Sciences; Head of the Clinical Department

SPIN-code: 1645-5524

ul. Trubetskaya 8, build. 2, Moscow, 119991;

Orekhovyy bul’var 28, Moscow, 115682

tel.: (495) 708-35-76

 


Competing Interests:

Arkhipov V.V. reports lecturing for AstraZeneca, Bayer AG, Boehringer Ingelheim, Chiesi Pharmaceuticals LLC, GlaxoSmithKline, Merck&Co, Novartis, TEVA, Zambon Pharma. Aisanov Z.R. – Writing articles and giving lectures for Chiesi Pharmaceuticals LLC. Avdeev S.N. – Writing articles and giving lectures for Chiesi Pharmaceuticals LLC.



References

1. Bateman E.D., Boushey H.A., Bousquet J. et al. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am. J. Respir. Crit. Care Med. 2004; 170 (8): 836–844. DOI: 10.1164/rccm.200401-033OC.

2. Pauwels R.A., Pedersen S., Busse W.W. et al. Early intervention with budesonide in mild persistent asthma: a randomised, double-blind trial. Lancet. 2003; 361 (9363): 1071–1076. DOI: 10.1016/S0140-6736(03)12891-7.

3. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. Update 2019. Available at: https://ginasthma.org/wp-content/uploads/2019/06/GINA-2019-main-report-June-2019-wms.pdf

4. Chuchalin A.G., Aisanov Z.R., Belevskiy A.S. et al. [Russian Respiratory Society national guidelines on diagnosis and management of patients with bronchial asthma]. Pul’monologiya. 2014; (2): 11–32. DOI: 10.18093/0869-0189-2014-0-2-11-32 (in Russian).

5. Rabe K.F., Vermeire P.A., Soriano J.B., Maier W.C. Clinical management of asthma in 1999: the Asthma Insights and Reality in Europe (AIRE) study. Eur. Respir. J. 2000; 16 (5): 802–807. DOI: 10.1183/09031936.00.16580200.

6. Partridge M.R., van der Molen T., Myrseth S.E., Busse W.W. Attitudes and actions of asthma patients on regular maintenance therapy: the INSPIRE study. BMC Pulm. Med. 2006; 6: 13. DOI: 10.1186/1471-2466-6-13.

7. Price D., Fletcher M., van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim. Care Respir. Med. 2014; 24: 14009. DOI: 10.1038/npjpcrm.2014.9.

8. Braido F., Brusselle G., Guastalla D. et al. Determinants and impact of suboptimal asthma control in Europe: The international cross-sectional and longitudinal assessment on asthma control (LIAISON) study. Respir. Res. 2016; 17: 51. DOI: 10.1186/s12931-016-0374-z.

9. Demoly P., Annunziata K., Gubba E., Adamek L. Repeated cross-sectional survey of patient-reported asthma control in Europe in the past 5 years. Eur. Respir. Rev. 2012; 21 (123): 66–74. DOI: 10.1183/09059180.00008111.

10. Arkhipov V.V., Grigoryeva E.V., Gavrishina E.V. [Control of bronchial asthma in Russia: results of NIKA multi-center observational study]. Pul’monologiya. 2011; (6): 87–93. DOI: 10.18093/0869-0189-2011-0-6-87-93 (in Russian).

11. Herland K., Akselsen J.P., Skjønsberg O.H., Bjermer L. How representative are clinical study patients with asthma or COPD for a larger “real life” population of patients with obstructive lung disease? Respir. Med. 2005; 99 (1): 11–19. DOI: 10.1016/j.rmed.2004.03.026.

12. Bjermer L. Evidence-based recommendations or “Show me the patients selected and I will tell you the results”. Respir. Med. 2006; 100 (Suppl. 1): S17–21. DOI: 10.1016/j.rmed.2006.03.023.

13. Braunholtz D.A., Edwards S.J.L., Lilford R.J. Are randomized clinical trials good for us (in the short term)? Evidence for a “trial effect”. J. Clin. Epidemiol. 2001; 54 (3): 217–224. DOI: 10.1016/s0895-4356(00)00305-x.

14. Vrijens B., Dima A.L., Van Ganse E. et al. What we mean when we talk about adherence in respiratory medicine. J. Allergy Clin. Immunol. Pract. 2016; 4 (5): 802–812. DOI: 10.1016/j.jaip.2016.05.019.

15. Conn V.S., Ruppar T.M. Medication adherence outcomes of 771 intervention trials: Systematic review and meta-analysis. Prev. Med. 2017; 99: 269–276. DOI: 10.1016/j.ypmed.2017.03.008.

16. Price D., Brusselle G., Roche N. et al. Real-world research and its importance in respiratory medicine. Breathe. 2015; 11 (1): 26–38. DOI: 10.1183/20734735.015414.

17. Plaza V., Fernández-Rodríguez C., Melero C. et al. Validation of the “Test of the Adherence to Inhalers” (TAI) for asthma and COPD patients. J. Aerosol. Med. Pulm. Drug Deliv. 2016; 29 (2): 142–152. DOI: 10.1089/jamp.2015.1212.

18. Juniper E.F., Svensson K., Mörk A.C., Ståhl E. Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir. Med. 2005; 99 (5): 553–558. DOI: 10.1016/j.rmed.2004.10.008.

19. Miller M.R., Hankinson J., Brusasco V. et al. Standardisation of spirometry. Eur. Respir. J. 2005; 26 (2): 319–338. DOI: 10.1183/09031936.05.00034805.

20. Chung K.F., Wenzel S.E., Brozek J.L. et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur. Respir. J. 2014; 43 (2): 343–373. DOI: 10.1183/09031936.00202013.

21. Tashkin D.P., Chipps B.E., Trudo F., Zangrilli J.G. Fixed airflow obstruction in asthma: a descriptive study of patient profiles and effect on treatment responses. J. Asthma. 2014; 51 (6): 603–609. DOI: 10.3109/02770903.2014.895012.

22. Carr T.F., Zeki A.A., Kraft M. Eosinophilic and noneosinophilic asthma. Am. J. Respir. Crit. Care Med. 2018; 197 (1): 22–37. DOI: 10.1164/rccm.201611-2232PP.

23. Beuther D.A. Obesity and asthma. Clin. Chest Med. 2009; 30 (3): 479–488. DOI: 10.1016/j.ccm.2009.05.002.

24. Ulrik C.S., Backer V. Nonreversible airflow obstruction in life-long nonsmokers with moderate to severe asthma. Eur. Respir. J. 1999; 14 (4): 892–896. DOI: 10.1034/j.1399-3003.1999.14d27.x.

25. ten Brinke A., Zwinderman A.H., Sterk P.J. et al. Factors associated with persistent airflow limitation in severe asthma. Am. J. Respir. Crit. Care Med. 2001; 164 (5): 744–748. DOI: 10.1164/ajrccm.164.5.2011026.

26. Miranda C., Busacker A., Balzar S. et al. Distinguishing severe asthma phenotypes: role of age at onset and eosinophilic inflammation. J. Allergy Clin. Immunol. 2004; 113 (1): 101–108. DOI: 10.1016/j.jaci.2003.10.041.

27. Gibson P.G., McDonald V.M., Marks G.B. Asthma in older adults. Lancet. 2010; 376 (9743): 803–813. DOI: 10.1016/S0140-6736(10)61087-2.

28. Avdeev S.N., Aisanov Z.R., Arkhipov V.V. et al. [Agreed recommendations on the rationale for the choice of therapy for bronchial asthma and chronic obstructive pulmonary disease, taking into account the phenotype of the disease and the role of small airways]. Atmosfera. Pul’monologiya i allergologiya. 2013; (2); 15–26. Available at: http://www.atmosphere-ph.ru/modules/Magazines/articles/pulmo/ap_2_2013_15.pdf (in Russian).


Review

For citations:


Arkhipov V.V., Aisanov Z.R., Avdeev S.N. Effectiveness of inhaled corticosteroids and long-acting β-agonists combinations in real clinical practice: results of a multicenter cross-sectional study in Russian patients with asthma. PULMONOLOGIYA. 2021;31(5):613-626. (In Russ.) https://doi.org/10.18093/0869-0189-2021-31-5-613-626

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