Efficacy and safety of Rengalin in treatment of cough in adults with upper respiratory tract infections: results of a randomized controlled double-blind trial


DOI: https://dx.doi.org/10.18565/therapy.2019.1.125-140

Hamitov R.F., Ilkovich M.M., Akopov A.L., Mihailusova M.P., Petrov D.V., Alpenidze D.N., Shapovalova Yu.S., Kozyrev O.A., Abramenkova N.Y., Shunkov V.B., Pavlysh E.F., Erofeeva S.B.

1 Kazan State Medical University, Russia; 2 I.P. Pavlov First Saint Petersburg State Medical University, St. Petersburg, Russia; 3 Pirogov Russian National Research Medical University, Moscow, Russia; 4 Yaroslavl State Medical University, Yaroslavl, Russia; 5 Municipal Policlinic № 117, St. Petersburg, Russia; 6 Chelyabinsk Road Clinical Hospital «Russian Railways», Chelyabinsk, Russia; 7 Smolensk state medical University, Smolensk, Russia; 8 Regional State Policlinic № 6, Smolensk, Russia; 9 Road Clinical Hospital «Russian Railways», St. Petersburg, Russia; 10 Saint Petersburg State Municipal Policlinic №25 of Nevsky district, St. Petersburg, Russia; 11 Clinic «Bessler», Moscow, Russia
Upper respiratory tract infections (URTI) are the most common cause of acute cough. Dry cough significantly disrupts daytime activity and night sleep and requires active treatment. Objective: efficacy and safety assessment of a new liquid dosage form of Rengalin in the treatment of cough in adults with URTI. Material and methods. We did a randomised controlled double blind trial of 344 patients (mean age 39,5±13,9 years) with the clinically established diagnosis of URTI; the duration of dry cough varied between 12 hours and 3 days. The observation time was 8 days. Primary efficacy endpoints were the percent of the patients with improvement or cough absence, cough duration (scored using a cough severity scale). Results. The improvement or cough absence after 3 days of treatment was 50 [52]% with Rengalin versus 37 [38]% with placebo (p=0,018 [p=0,011]), after 7 days of treatment – 95 [96]% and 93 [94]% respectively (p=0,42 [p=0,36]). The total duration of cough was significantly shorter with Rengalin (p=0,0024 [p=0,0019]). Within 7 days of treatment, the daily cough severity decreased to 1,0±0,9 [1,0±0,8] points with rengalin and 1,2±0,9 [1,2±0,9] points with placebo; night cough to 0,1±0,4 [0,1±0,4] points and 0,3±0,5 [0,3±0,6] points in groups, respectively (p <0,0001 [p <0,0001]). The highest efficacy of Rengalin was observed during the night (p=0,0011 [p=0,0008]). After 3-day course of the Rengalin therapy, 32[32%] of the patients were treated with ambroxol versus 41[43%] in the placebo group (p=0,08 [p=0,04]). The therapeutic efficacy in the Rengalin group (CGI-EI scale) was higher than in the placebo group (p=0,02 [p=0,02]). Rengalin didn`t increase adverse events frequency (p=0,37). Conclusion. The liquid dosage form of Rengalin was effective and well tolerated in the treatment of cough in adults with URTI.

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About the Autors


Rustem F. Hamitov, MD, professor, head of the Department of internal diseases of «Kazan state medical university» State Budget Educational Institution of HE. Address: 420101, Kazan, 2 Mavlyutova St. Tel.: +78432245131.
E-mail: rhamitov@mail.ru


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