Evaluation of the effectiveness of beclomethasone dipropionate/ formoterol fumarate in patients with bronchial asthma with osmotic airway hyperresponsiveness

In the scientific literature, there is no information on the effectiveness of the use of beclomethasone dipropionate/formoterol fumarate in the form of extrafine aerosol for inhalations in asthma patients with osmotic airway hyperresponsiveness. We aimed to study additional possibilities of targeted use of beclomethasone dipropionate/formoterol fumarate in patients with asthma, aimed at reducing the sensitivity of the bronchi to osmotic stimulus and achieving better control. There were examined 16 patients with mild persistent asthma and proven osmotic airway hyperresponsiveness; the analysis of clinical symptoms of asthma was done in them; the control of asthma by Asthma Control Test (ACT), the lung function, the airway reaction to the inhalation of aerosol of distilled water (IDW) at the beginning and after a 12-week course of therapy with beclomethasone dipropionate/formoterol fumarate at a dose equivalent to the severity of asthma were assessed. By the end of the treatment period, 81% of patients had well control (≥20-24 points according to the results of ACT), 19% achieved complete control (25 points), the ACT value in the group averaged 22.5±3.0 points (p=0.00001). The frequency of episodes of shortness of breath during the day (χ²=18.66; p<0.001) and at night (χ²=12.96; p<0.001) decreased. Along with the positive dynamics of the clinical picture, there was a significant increase in the lung function: FEV₁ from 92.1±3.9 to 102.1±3.4% (p=0.0296); MEF_25-75 from 56.8±7.0 to 76.8±4.3% (p=0.0058). Against the background of the 12-week treatment 75% of patients had regression of response to IDW: ΔFEV₁ from -18.1±2.3 to -5.3±1.9% (p=0.0001); ΔMEF_25-75 from -27.5±3.8 to -7.8±3.3% (p=0.0003). Thus, the results of the clinical study showed that in asthma patients with osmotic airway hyperresponsiveness the use of extrafine aerosol for inhalation of beclomethasone dipropionate/formoterol fumarate for 12 weeks leads to a decrease in clinical symptoms, improvement of asthma control, and a decrease in airway hyperresponsiveness to hypoosmotic stimulus.

1. Il'in A.V., Perelman J.M., Prikhod'ko A.G., Lenshin A.V. Interrelation of potency and reactivity of small bronchi with lung hyperinflation in patients with bronchial asthma and cold airway hyperresponsiveness. Dal'nevos-tochnyy meditsinskiy zhurnal 2014; 3:18-22 (in Russian).

2. Perel'man J.M., Naumov D.E., Prikhod'ko A.G., Kolosov V.P. Mechanisms and manifestations of osmotic airway hyperresponsiveness. Vladivostok: Dal'nauka; 2016 (in Russian).

3. Prikhodko A.G., Perelman J.M., Kolosov V.P. Airway hyperresponsiveness. Vladivostok: Dal’nauka; 2011 (in Russian).

4. Fassahov R.S. The role of the distal airways in bronchial asthma. New inhalation therapy options. Consilium medicum. Respiratory diseases 2010; 1:33-37 (in Russian).

5. Allegra L., Cremonesi G., Girbino G., Ingrassia E., Marsico S., Nicolini G., Terzano C.; PRISMA (PRospec-tlve Study on asthMA control) Study Group. Real-life prospective study on asthma control in Italy: Cross-sectional phase results. Respir. Med. 2012; 106(2):205-214. doi: 10.1016/j.rmed.2011.10.001

6. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention (Updated 2018). Available at: www.ginasthma.com.

7. Miller M.R., Crapo R., Hankinson J., Brusasco V., Burgos F., Casaburi R., Coates A., Enright P., van der Grinten C.P., Gustafsson P., Jensen R., Johnson D.C., MacIntyre N., McKay R., Navajas D., Pedersen O.F., Pellegrino R., Viegi G., Wanger J. General considerations for lung function testing. Eur. Respir. J. 2005; 26:153-161. doi: 10.1183/09031936.00130010

8. Miller M.R., Hankinson J., Brusasco V., Burgos F., Casaburi R., Coates A., Crapo R., Enright P., van der Grinten C.P.M., Gustafsson P., Jensen R., Johnson D.C., MacIntyre N., McKay R., Navajas D., Pedersen O.F., Pellegrino R., Viegi G., Wanger J. Standardisation of spirometry. Eur. Respir. J. 2005; 26:319-338. doi:10.1183/09031936.05.00034805

9. Muller V., Galffy G., Eszes N., Losonczy G., Bizzi A., Nicolini G., Chrystyn H., Tamasi L. Asthma control in patients receiving inhaled corticosteroid and long-acting beta2-agonist fixed combinations. A real-life study comparing dry powder inhalers and a pressurized metered dose inhaler extrafine formulation. BMC Pulmonary Medicine 2011; 11:40-45. doi: 10.1186/1471-2466-11-40