PMID- 33981141
OWN - NLM
STAT- MEDLINE
DCOM- 20210727
LR  - 20220531
IS  - 1178-2005 (Electronic)
IS  - 1176-9106 (Print)
IS  - 1176-9106 (Linking)
VI  - 16
DP  - 2021
TI  - Management of Cough in Patients with Chronic Obstructive Pulmonary Disease: 
      Results of the Multicenter Randomized Placebo-Controlled Clinical Trial.
PG  - 1243-1253
LID - 10.2147/COPD.S292109 [doi]
AB  - BACKGROUND: Chronic cough declines quality of life and increases risk of 
      complications in patients with chronic obstructive pulmonary disease (COPD). 
      Reducing cough severity and associated negative effects is important therapeutic 
      goal in COPD. Rengalin with anti- and protussive activity is based on 
      technologically processed antibodies to bradykinin, histamine and morphine. AIM: 
      To evaluate efficacy and safety of Rengalin in treatment of cough in patients 
      with COPD. METHODS: Patients (n=238, mean age 64.3+/-8.2 years) with stable COPD 
      and persistent cough despite maintenance therapy (anticholinergics, 
      beta-2-adrenergic agonists, inhaled corticosteroids) were included and randomized 
      in the study. The severity of cough assessment (according to the "Cough Severity 
      Score"), COPD impact on patient's life (COPD Assessment Test, CAT), and 
      spirometry were performed at screening. Patients took Rengalin or Placebo 2 
      tablets 2 times daily for 4 weeks. The endpoints were proportion of patients who 
      responded to treatment, dynamics of cough severity, and severity of COPD 
      symptoms. Intention-to-treat (per protocol) analysis was performed. RESULTS: 
      Positive response to Rengalin was recorded in 83.6 [85.7]% (vs 72.6 [72.7]% in 
      Placebo group, p=0.0422 [p=0.0163]). Double decrease of cough severity was 
      reported in 42.2 [43.8]% in Rengalin group (versus 32.7 [32.7]% in Placebo; 
      p=0.1373 [p=0.0907]). The total CAT score decreased by 3.3+/-4.2 [3.6+/-3.9] points 
      (versus 2.5+/-4.1 [2.5+/-4.2] in Placebo group); the difference between groups was 
      0.79+/-4.16 [1.04+/-4.02] points (p=0.0870 [p=0.0416]). The number of patients with 
      adverse events (AEs) in Rengalin (n=13) and Placebo (n=12) groups did not have 
      significant differences (p=1.00). No AEs with certain relationship with study 
      drug were registered. CONCLUSION: Rengalin is an effective and safe drug in 
      patients with stable COPD and persistent cough, despite stable doses of 
      maintenance therapy according to the GOLD guidelines. Four-week therapy decreases 
      severity of cough by two times in more than 40% of patients. TRIAL REGISTRATION: 
      ClinicalTrials.gov (id: NCT03159091).
CI  - (c) 2021 Avdeev et al.
FAU - Avdeev, Sergey N
AU  - Avdeev SN
AUID- ORCID: 0000-0002-5999-2150
AD  - I.M. Sechenov First Moscow State Medical University, Moscow, Russia.
FAU - Vizel, Alexander A
AU  - Vizel AA
AD  - Kazan State Medical University, Kazan, Russia.
FAU - Abrosimov, Vladimir N
AU  - Abrosimov VN
AD  - Ryazan State Medical University Named After Academician I.P. Pavlov, Ryazan, 
      Russia.
FAU - Zaicev, Andrey A
AU  - Zaicev AA
AD  - The Main Military Clinical Hospital Named After Academician N.N. Burdenko, 
      Moscow, Russia.
FAU - Ignatova, Galina L
AU  - Ignatova GL
AD  - Regional Clinical Hospital No. 4, Chelyabinsk, Russia.
FAU - Khamitov, Rustem F
AU  - Khamitov RF
AD  - Kazan State Medical University, Kazan, Russia.
FAU - Mikhaylusova, Marina P
AU  - Mikhaylusova MP
AD  - Pirogov Russian National Research Medical University, Moscow, Russia.
FAU - Shapovalova, Julia S
AU  - Shapovalova JS
AD  - Chelyabinsk Road Clinical Hospital "Russian Railways", Chelyabinsk, Russia.
FAU - Pavlysh, Elena F
AU  - Pavlysh EF
AD  - Nikiforov's All-Russian Center for Emergency and Radiation Medicine of the 
      Emergencies, St. Petersburg, Russia.
FAU - Trofimov, Basil I
AU  - Trofimov BI
AD  - I.P. Pavlov First Saint Petersburg State Medical University, St. Petersburg, 
      Russia.
FAU - Emelyanov, Alexander V
AU  - Emelyanov AV
AD  - North-Western State Medical University Named After I.I. Mechnikov, St. 
      Petersburg, Russia.
FAU - Martynenko, Tatiana I
AU  - Martynenko TI
AUID- ORCID: 0000-0001-7577-6020
AD  - Regional State City Hospital No. 5, Barnaul, Russia.
FAU - Martynenko, Vladimir A
AU  - Martynenko VA
AD  - Regional State Clinical Hospital, Barnaul, Russia.
FAU - Kostina, Natalia E
AU  - Kostina NE
AD  - Voronezh Regional Clinical Hospital No. 1, Voronezh, Russia.
FAU - Chizhov, Danila A
AU  - Chizhov DA
AD  - St. Petersburg State City Polyclinic No. 106, St. Petersburg, Russia.
FAU - Chizhova, Olga Yu
AU  - Chizhova OY
AD  - North-Western State Medical University Named After I.I. Mechnikov, St. 
      Petersburg, Russia.
FAU - Kuzubova, Natalia A
AU  - Kuzubova NA
AD  - St. Petersburg State Vvedenskaya City Clinical Hospital, St. Petersburg, Russia.
FAU - Makova, Elena V
AU  - Makova EV
AUID- ORCID: 0000-0002-7600-4978
AD  - State Samara City Hospital No. 4, Samara, Russia.
FAU - Makarova, Ekaterina V
AU  - Makarova EV
AUID- ORCID: 0000-0003-4394-0687
AD  - Privolzhsky Research Medical University, Nizhny Novgorod, Russia.
AD  - State City Clinical Hospital No. 10, Nizhny Novgorod, Russia.
LA  - eng
SI  - ClinicalTrials.gov/NCT03159091
PT  - Case Reports
PT  - Clinical Trial
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20210505
PL  - New Zealand
TA  - Int J Chron Obstruct Pulmon Dis
JT  - International journal of chronic obstructive pulmonary disease
JID - 101273481
RN  - 0 (Adrenal Cortex Hormones)
SB  - IM
MH  - Adrenal Cortex Hormones
MH  - Aged
MH  - Cough/diagnosis/drug therapy/etiology
MH  - Double-Blind Method
MH  - Humans
MH  - Middle Aged
MH  - *Pulmonary Disease, Chronic Obstructive/complications/diagnosis/drug therapy
MH  - Quality of Life
PMC - PMC8107011
OTO - NOTNLM
OT  - Rengalin
OT  - chronic obstructive pulmonary disease
OT  - cough
OT  - cough management
OT  - treatment
COIS- Avdeev S.N., MD, PhD, professor, Vizel' A.A., MD, PhD, professor, Abrosimov V.N., 
      MD, PhD, professor, Ignatova G.L., MD, PhD, professor, Khamitov R.F., MD, PhD, 
      professor, Mikhaylusova M.P., MD, PhD, Shapovalova Yu.S., MD, PhD, Pavlysh E.F., 
      MD, PhD, Trofimov V.I., MD, PhD, professor, Emel'yanov A.V., MD, PhD, professor, 
      Martynenko T.I., MD, PhD, professor, Martynenko V.A., MD, PhD, Kostina N.E., MD, 
      PhD, Chizhov D.A., MD, Chizhova O.Yu., MD, PhD, professor, Kuzubova N.A., MD, 
      PhD, Makova E.V., MD, PhD, and Makarova E.V., MD, PhD received an investigator 
      grant from Materia Medical Holding to conduct the clinical trial of Rengalin 
      mentioned in this article. The authors report no other conflicts of interest in 
      this work.
EDAT- 2021/05/14 06:00
MHDA- 2021/07/28 06:00
PMCR- 2021/05/05
CRDT- 2021/05/13 06:23
PHST- 2020/11/14 00:00 [received]
PHST- 2021/03/14 00:00 [accepted]
PHST- 2021/05/13 06:23 [entrez]
PHST- 2021/05/14 06:00 [pubmed]
PHST- 2021/07/28 06:00 [medline]
PHST- 2021/05/05 00:00 [pmc-release]
AID - 292109 [pii]
AID - 10.2147/COPD.S292109 [doi]
PST - epublish
SO  - Int J Chron Obstruct Pulmon Dis. 2021 May 5;16:1243-1253. doi: 
      10.2147/COPD.S292109. eCollection 2021.