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Trial for Inhalation Introduction of Glutoxim-Containing Formulation in Children Patients with COPD.

T.Y. Gembitskaya, M.A. Zaitseva, L.A. Kozhemyakin, A.V. Molodtsova

BAM R&D Laboratories, Ltd, Saint Petersburg, Russia

The aim was to learn efficacy of inhalation administration of the Glutoxim-containing formulation and therapeutic agents for basic inhalation treatment in chronically obstructive pulmonary disease (COPD) patients. Sixteen patients having prevailing pulmonary form of the COPD with signs of exacerbation of infectious-inflammation process at the time of the study were enrolled. The patients were distributed into two arms - experimental (I) and control (II). The group I patients were treated with antibacterial therapy and daily inhalations of Glutoxim and cofactors through nebulizer during 10 days. The group II patients were administered with antibacterial, mucolytic agents and daily inhalations of anticholinergic and b-adrenomimetic agents through nebulizer. By the end of the study clinical indices in the groups I and II were found to have significant changes indicated with diminution of dyspnea, coughing, amount of sputum, decreased sputum viscosity and lowered number of rales. The external respiration parameters indicated improved bronchial patency both in the groups I and II (significant 10-15% increase of FEV1 and PEFR comparing to the baseline data). There were not found any significant differences between groups I and II.

The patients noted good tolerance for the new formulation and absence of undesirable side effects. We conclude that the Glutoxim-containing formulation introduced through nebulizer application in the COPD patients has effective broncholytic and anti-inflammatory activity comparable with the conventional inhalation therapy. The drug effects are determined with mutually potentiating action of the active formulation components by regulation of the inflammatory process development in a bronchial wall and restoration of lung antibacterial protection.

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