Combination therapy for productive cough in acute respiratory viral infection (ARVI) and acute bronchitis in real clinical practice

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Abstract

Aim. To evaluate effectiveness and safety of combination drug containing ambroxol, guaifenesin and levosalbutamol (Ascoril LS), oral solution, in comparison with monocomponent drugs in the treatment of productive cough in adult patients with acute respiratory viral infection (ARVI) and acute bronchitis.

Materials and methods. Open randomized study included patients with clinical symptoms of ARVI and acute bronchitis, having productive cough with difficulty in sputum discharge. 160 patients were randomized into 4 groups that received the study drug or comparison drugs (ambroxol, acetylcysteine, Rengalin) 3 times a day for 20 days. After 5, 10, 15 and 20 days of treatment, the doctor assessed subjective complaints and effectiveness of therapy. The primary endpoint was the proportion of patients with high and very high efficacy, recovery from work, and clinically significant cardiovascular events.

Results. Satisfaction with clinical effect of therapy with Ascoril LS was noted by 96% of patients, tolerability and ease of administration by 99%. 97% of patients are satisfied with price/quality ratio. The overall percentage of satisfaction with treatment Ascoril LS was 99%. Tolerability of therapy was assessed by all patients as good, without the development of significant adverse events. During therapy for productive cough, a significant decrease in cough was noted in Ascoril LS group already on the 5th day of therapy (57%) and subsequently at all follow-up visits. Restoration of working capacity of patients in Ascoril LS group due to complete regression of productive cough was established in 50% of patients on the 5th day of treatment. On days 10 and 15, 75% and 90% of patients, respectively, were able to begin work due to complete relief of cough, which is significantly more compared to other treatment groups. It is important that in all cases Ascoril LS was prescribed at the very beginning of the disease, which made it possible to achieve the described results

Conclusion. The effectiveness of a new combination drug containing ambroxol, guaifenesin and levosalbutamol for the treatment of productive cough in adult patients with ARVI and acute bronchitis exceeds the effectiveness of monocomponent therapy with comparator drugs. The safety profiles of the study drug and comparison drugs were comparable, including in patients with cardiovascular risk.

About the authors

Igor V. Leshchenko

Ural State Medical University; Ural Research Institute of Phthisiopulmonology – branch of the National Medical Research Center for Phthisiopulmonology and Infectious Diseases; LLC «Medical Association “New Hospital”»

Email: esanat@yandex.ru
ORCID iD: 0000-0002-1620-7159

доктор медицинских наук, профессор кафедры фтизиатрии и пульмонологии ФГБОУ ВО УГМУ, гл. научный сотрудник научно-клинического отд. УНИИФ – филиала ФГБУ НМИЦ ФПИ, научный рук. клиники ООО «МО "Новая больница"»

Russian Federation, Yekaterinburg; Yekaterinburg; Yekaterinburg

Natalia A. Esaulova

Ural State Medical University; Ural Research Institute of Phthisiopulmonology – branch of the National Medical Research Center for Phthisiopulmonology and Infectious Diseases

Author for correspondence.
Email: esanat@yandex.ru
ORCID iD: 0000-0001-9565-3570

кандидат медицинских наук, доцент кафедры фтизиатрии и пульмонологии ФГБОУ ВО УГМУ, зав. отделением дифференциальной диагностики туберкулеза УНИИФ – филиала ФГБУ НМИЦ ФПИ

Russian Federation, Yekaterinburg; Yekaterinburg

References

  1. Зайцев А.А., Лещенко И.В. Острый бронхит. Методические рекомендации. М.: ГВКГ им. Н.Н. Бурденко, 2022 [Zaitsev AA, Leshchenko IV. Ostryi bronkhit. Metodicheskie rekomendatsii. Moscow: GVKG im. N.N. Burdenko, 2022 (in Russian)].
  2. Morice AH, McGarvey L, Pavord I; British Thoracic Society Cough Guideline Group. Recommendations for the management of cough in adults. Thorax. 2006;61(Suppl. 1):i1-24. doi: 10.1136/thx.2006.065144
  3. Зайцев А.А., Оковитый С.В. Кашель: дифференциальный диагноз и рациональная фармакотерапия. Терапевтический архив. 2014;86(12):85-91 [Zaitsev AA, Okovityi SV. Cough: Differential diagnosis and rational pharmacotherapy. Terapevticheskii Arkhiv (Ter. Arkh.). 2014;86(12):85-91 (in Russian)]. doi: 10.17116/terarkh2014861285-91
  4. Зайцев А.А., Оковитый С.В., Крюков Е.В. Современные возможности мукоактивной терапии. Фарматека. 2015;14:81-4 [Zaitsev AA, Okovityi SV, Kryukov EV. Modern potentials of mucoactive therapy. Pharmateka. 2015;14:81-4 (in Russian)].
  5. Yousaf N, Lee KK, Jayaraman B, et al. The assessment of quality of life in acute cough with the Leicester Cough Questionnaire (LCQ-acute). Cough. 2011;7(1):4. doi: 10.1186/1745-9974-7-4
  6. Brat K, Stastna N, Merta Z, et al. Cardiopulmonary exercise testing for identification of patients with hyperventilation syndrome. PLoS One. 2019;14(4):e0215997. doi: 10.1371/journal.pone.0215997
  7. Parvez L, Vaidya M, Sakhardande A, et al. Evaluation of antitussive agents in man. Pulm Pharmacol. 1996;9(5-6):299-308. doi: 10.1006/pulp.1996.0039
  8. Оковитый С.В., Анисимова Н.А. Фармакологические подходы к противокашлевой терапии. РМЖ. 2011;23:1450 [Okovityi SV, Anisimiva NA. Pharmacological approaches to antitussive therapy. RMJ. 2011;23:1450 (in Russian)].
  9. Зайцев А.А., Лещенко И.В., Эсаулова Н.А., Викторова И.А. Оценка эффективности и безопасности комбинированного препарата, содержащего амброксол, гвайфенезин и левосальбутамол, в сравнении с фиксированной комбинацией бромгексин/гвайфенезин/сальбутамол в терапии продуктивного кашля у взрослых пациентов с острым бронхитом. Терапевтический архив. 2023;95(3):236-42 [Zaitsev AA, Leshchenko IV, Esaulova NA, Viktorova IA. Evaluation of the efficacy and safety of a combination drug containing ambroxol, guaifenesin, and levosalbutamol versus a fixed-dose combination of bromhexine/guaifenesin/salbutamol in the treatment of productive cough in adult patients with acute bronchitis. Terapevticheskii Arkhiv (Ter. Arkh.). 2023;95(3):236-42 (in Russian)]. doi: 10.26442/00403660.2023.03.202099
  10. Лиджиева А.А., Смолярчук ЕА. Левосальбутамол – новые возможности лечения бронхиальной астмы. Ведомости НЦЭСМП. 2015;(2):25-8 [Lidzhieva АА, Smolyarchuk ЕА. Levosalbutamol and new opportunities for the treatment of bronchial asthma (review of the related studies). Scientific Centre for Expert Evaluation of Medicinal Products Bulletin. 2015;(2):25-8 (in Russian)].
  11. Малявин А.Г., Белоцерковская Ю.Г., Болиева Л.З., и др. Практические аспекты применения новой фиксированной комбинации препаратов амброксол + гвайфенезин + левосальбутамол в терапии острого бронхита у взрослых. Резолюция совета экспертов. Профилактическая медицина. 2023;26(6):108-12 [Malyavin AG, Belotserkovskaya YuG, Bolieva LZ, et al. Practical aspects of the application of a new drug combination of ambroxol + guaiphenesine + levosalbutamol in the treatment of acute bronchitis in adults. Experts council resolution. Profilakticheskaya Meditsina. 2023;26(6):108-12 (in Russian)]. doi: 10.17116/profmed202326061108

Supplementary files

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2. Fig. 1. Study design.

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3. Fig. 2. Types of coughs in patients with acute respiratory infections, acute bronchitis (n=2107).

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4. Fig. 3. Dynamics of regression of productive cough in comparison groups by day. Here in after in Figs. 4–8: n=160, *р<0.05.

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5. Fig. 4. Dynamics of regression of daytime cough and sputum production according to the BOC scale in treatment groups.

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6. Fig. 5. Dynamics of regression of night time cough and sputum production according to the BOC scale in treatment groups.

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7. Fig. 6. Terms of recovery of working capacity of patients in study groups.

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8. Fig. 7. Dynamics of recovery of patients in comparison groups.

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9. Fig. 8. Incidence of cardiovascular events in comparison groups.

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