The results and findings of studies of preclinical and clinical efficacy and safety of the Company’s medications and their components are published in Russian and international peer-reviewed scientific journals, including those indexed by international bibliographic databases.
Preclinical and clinical studies of medical preparations (rengalin, ergoferon) containing release-active (P-A) antibodies to histamine confirmed their ability to provide anti-inflammatory and anti-allergic effect. The mechanism of action of release-active antibodies to histamine is based upon their influence on histamine-dependent activation of histamine receptors. It is shown that P-A antibodies to histamine can effectively eliminate associated allergic infections and inflammatory reactions
Aim: comparative clinical assessment of efficiency and drug safety of Rengalin and fenspiride. The research was made with participation of 54 patients: 26 people in Rengalin's group and 28 in the group of fenspiride. Therapy duration in both groups was for 7 days. The following criteria were considered: cooperative clinical index (characterizes total disappearance of symptoms at the end of therapy), terms of stopping of day and night cough, average value of the cooperative cough index during observation (from visit 1 to visit 3), CGI-EI scale GPAs, assessment of efficiency and commitment to the therapy.
Results: both Rengalin, and fenspiride are effective, but the combination of therapeutic properties of Rengalin is more preferable in treatment of acute bronchitis. Тhe number of recovered patients prevailed tin the Rengalin's group, р<0,01, and also on CGI-EI scale, р<0,001.
Conclusion. Regalin is preferred for the treatment of acute bronchitis.
Cough is one of the most common symptoms of acute respiratory infections (ARI), manifesting and maintaining with participation of all its launchers factors and mechanisms and is a multifactorial problem.
Objective: To estimate the efficacy of cough treatment in adults with ARI with complex drugs with different mechanisms of action. The study was open-label, comparative, randomized and included outpatients.
Material and Methods: the study included 60 patients aged 18 to 75 years, with ARI, developed between 7-14th days before the screening visit. The main inclusion criterion was cough, non-productive / unproductive at the time of screening, started not less than 7 days before the screening. Complex preparations. Rengalin® and Stoptussin® were prescribed in accordance with appropriate schemes. The investigator examined the patient at least for 2 times – on the 1st visit, at the time of enrollment, on the 2nd visit (on the 7 th (±1) day of treatment). If the doctor made the decision to continue therapy on the 2nd visit, he appointed the 3d visit ( on 14 th (±1) day of treatment).
Results: Patients were divided into 2 groups (n=30). Group 1 was treated with Rengalin, Group 2 was treated with Stoptussin. All 60 patients visited the investigator for 2 times. 12 patients (7 – from group 1 and 5 – from group 2) had the 3d visit. Cough syndrome characteristics, clinical severity of ARI, efficacy and safety of the therapy are evaluated for all visits.
Discussion: Rengalin use in post-infectious cough treatment has significant therapeutic effects independently of the cough nature in shorter terms, without adverse events, including bacterial complications due to combination of antitussive, bronchodilator and anti-inflammatory effects.
Cough is considered to be one of the leading clinical symptoms associated with the pathological changes in the respiratory system. Notwithstanding a great variety of therapeutic pharmaceutical products possessed of the antitussive action, physicians tend the give preference to the preparations producing the combined effect. The present article reports the results of the clinical study designed to evaluate the effectiveness and safety of the application of rengalin exhibiting the combined antitussive, anti-inflammatory, and broncholytic action in the patients presenting with the postnasal drip syndrome. The comparison of the therapeutic effects of rengalin with those of other therapeutic modalities frequently employed for the management of postnasal drip give evidence of the high efficiency of this product for the optimization of the treatment of this condition and the associated chronic cough.
The paper represents the results of a multicenter comparative randomized clinical study of medication for the treatment of cough based on release-active antibodies in liquid dosage form when used for cough therapy in acute respiratory infections (ARI) of upper airways in children. The results confirm the efficiency and safety of medication for the treatment of cough based on release-active antibodies (in the form of a liquid for oral administration) for treating cough in children with ARI.
Rengalin liquid formulation on the basis of antibodies to bradlkinin histamine and morphine was specially designed for the treatment of cough in children. The three-component combination in therapeutically active against both dry and wet cough due to effect on diverse pathogenetic aspects of the cough reflex. The aim of the multicenter, comparative, randomized clinical trial was to estimate the efficacy and safety of rengalin in the treatment of cough in patients with acute respiratory infection (ARI) of the upper respiratory tract.
Methods. One hundred forty six patients at the age of 3 to 17 years (the average age of 8.2+3.6 years) from 14 medical centres of Russia were observed. The patients sufferedfrom dry/nonproductive, frequent, sore cough preventing from day-time activity and/or night sleep (>4 by the Cough Severity Scale). The cough duration ranged from 12 hours to 3 days. For 3 days the patients of group 1 (n=71) and group 2 (n=75) were treated with rengalin and sinekod (butamirate) respectively. For the following 4 days the patients (in case of viscid expectoration were treated with ambroxole in the age doses. The results of the Per Protokol Analysis (n=67 rengalin group and n=73 sinekod group) with an account of the Non-Infectiority Design are presented.
Results. In 3 days the number of the group 1 patients with significant improvement/recovery by the day and night estimates amounted to 90% and 88% respectively (vs. 81% and 88% in the group 2 patients, no night opisodes of cough after 3-days rengalin use being recorded in 52% of the patients vs. 34% in the sinekod group patients (p=0.0003). On the 7 th day of the treatment with rengalin the number of the children with significant improvement of or recovery from day-time cought amounted to 99%and that of the patients with significant improvement of or recovery from night-time cough amounted to 93%, in 90% of them no night-time cough being recorded (p=0.0008). As for the patients of the reference group, the respective values were 93% and 90%, no night-time cough being recorded in 81% of the patients. The time required for development of productive/moist cough during the 3-day treatment course in the patients of both the group was the same (2.9+0.3 days in the patients of group 1 and 2.9+0.4 days in the group 2 patients. Moreover, in 34% of the rengalin dry cough became residual (as rare episode of tussiculation with scantly exudation). After 3-day course of the rengalin therapy, 66% of the patients was treated with ambroxole (versus 95% in sinecod group (p<0.0001) based on comparative analysis and χ2=17.7, p>0.0001 by the results of the frequency analysis). The total duration of cough in the patients of groups 1 and 2 was 6.5±0.8 and 6.7±0.7 days respectively (the comparability truth, p=0.0001). The severity of the day-time cough by the area under the curve estimates for 7 days of the treatment in the rengalin group patients was equel to 14.3+5.6 numbers - days and that of the patients of the sinekod® group was equal to 15.9±6.1 numbers - days. The severity of the night-time cough was equal to 4.2+2.7 number - days respectively. In 2 patients (3%) treated with sinekod® signs of ARI generalization was observed after the 3-day treatment (p>0.0001). The research physicians-investigators (CGI-EL Scale) the combination of the anti- and protussive activities in one drug to be efficient and absolutely safe for the chilgren. The therapeutic efficacy in the patients of the rengalin group was higher in 3 days (2.1±0.5 numbers) and even in 7 days (2.7±0.5 numbers). The results value in the patients of the sinekod® group being 1.8±0.4 and 2.5±0.6 numbers (one-way ANOVA for repeated estimates ANOVA: Visit - F 1/138=146, p<0.0001, TREATMENT - F 1/138=9.0, p=0.003). The factor of the side effects in the patients of the rengalin group was zero (no side effects due to the treatment were recorded in the patients), whereas in the patients treated with sinekod® for 3 days the respective value was 0.1+0.3 (true superiority of rengalin by the ANOVA data. TREATMENT - F 1/138=4.7, p=0.03). The efficacy factor of the rengalin was also in its favour (ANOVA: Visit - F 1/138=182, p<0.0001, TREATMENT - F 1/138=7.3, p=0.008). In the patients treated with rengalin there were defected no deviations in the biochemical and general clinical analyses of blood and urine, no adverse reactions characteristic of antitussive drugs of the action. 100-percent adherence to the therapy was stated.
Conclusion. He antitussive effect of rengalin in the treatment of frequent dry day-time and night-time cough was observed earlier and proved to be comparable with that of butamirate (sinekod®). Rengalin prevented significant exudation and viscid expectoration in many patients, promoted rapid residual in the patients with dry cough and the patients recovery. The use of rengalin for 3 days significantly lowered the percentage of the patients requiring treatment with mucolytics at the subsequent stages of ARI.
Rengalin is a release-active combination antitussive drug based on antibodies to bradykinin, to histamine and morphine. It acts at various mechanisms of cough reflex by modifying endogenous target molecules and their interaction with receptors. The drug's efficacy, as demonstrated previously in experimental and clinical studies, is mediated by specific release-activity obtained as a result of the production process.
Methods. Efficacy and safety assessment of rengalin in the treatment of cough induced by acute upper respiratory tract infections (URIs) in comparison with a complex codeine-containing drug (codelac®) was performed as part of a multicenter, randomized clinical trial involving 143 patients. All the participants presented with dry/non-productive cough caused by URIs (pharyngitis, laryngitis, tracheitis, tracheobronchitis, bronchitis). The duration of cough varied between 12 hours and 7 days. Rengalin was administered in 73 patients receiving 2 tablets 3 times daily for initial three days, and half reduced doses - for the subsequent four days; codelac® was administered in 70 patients who were given 1 tablet 3 times daily for the entire treatment period (7 days). Primary efficacy endpoints were time to cough resolution and reduction in the severity of the cough (scored using a Cough Severity Scale). One patient in Rengalin group and three patients in Codelac group were withdrawn from the study. The article presents treatment outcomes obtained for 139 participants who completed the study in accordance with the protocol (Per Protokol-analysis). The data analysis was based on a non-inferiority (or comparability) statistical design for efficacy endpoints.
Results. The antitussive effect of rengalin was significantly comparable (р<0.025) with that of codelac®; the time to complete resolution of cough (both daytime and nocturnal) was 7.2+1.0 days (versus 7.0+1.1 in the group of codelac). Rengalin's efficacy was evidenced by a sufficiently reduced cough severity in the initial few days after treatment onset. As a result of the entire 7-day treatment, the severity score was reduced by 3.1+09 (versus 3.1+1.0 in the group of codelac; р<0.05), totaling 0.2+0.5 point in both groups at the end of the administration period. The frequent non-productive/dry cough was fully resolved in 76% of patients. All the participants in Rengalin group achieved either convalescent outcomes or significant improvement; none of the patients developed secondary bacterial complications. Positive changes in the patients' state over the week were finally confirmed by evaluating the total quality of life scores, including physical and mental component scores (SF-36 questionnaire), and total sleep quality scores, which were comparative between patients treated with rengalin and codelac® (р<0.025). At the end of the administration period, the effect of rengalin was rated by the physician investigators as 'pronounced'. The Clinical Global Impression Scale-Efficacy Indices (CGI-EI) in the groups of rengalin and codelac were comparable, equating a score of 3.7+0.5 (р<0.025). The safety outcomes of rengalin treatment were assessed across all 143 randomized patients. The drug's high safety profile was confirmed by the absence of adverse events that could be reliably related to the study treatment, and by monitoring of laboratory variables. Rengalin demonstrated good tolerability and favorable compatibility with other medications for URIs with concomitant pathology. The patients showed 100% treatment compliance.
Conclusions. Rengalin is a new efficacious and safe drug indicated for the treatment of URI-induced cough. The severity of daytime and nocturnal cough begins to decrease as soon as on the first day after rengalin administration, with severity reduction observed throughout the whole treatment period. At the completion of the 7-day administration, cough severity is reduced by almost 100% and its changes are comparable with the outcomes of treatment with codelac®. By targeting various cough reflex mediators, rengalin enables achieving an antitussive effect in the early days after URI onset (in dry, irritative cough episodes), and a pro-tussive effect at later points of treatment. Rengalin promotes resolution of URI-induced cough without development of secondary bacterial complications.