PMID- 37762768
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231003
IS  - 2077-0383 (Print)
IS  - 2077-0383 (Electronic)
IS  - 2077-0383 (Linking)
VI  - 12
IP  - 18
DP  - 2023 Sep 7
TI  - Effectiveness and Tolerability of Ectoin((R)) Mouth and Throat Spray Althaea Honey 
      (ERS09) for Sore Throat due to Acute Pharyngitis and Dry Cough: A Multicentre, 
      Actively Controlled, Open Label Study in Germany.
LID - 10.3390/jcm12185813 [doi]
LID - 5813
AB  - Acute pharyngitis can cause sore throat. This multicentre, active-controlled, 
      randomised, open-label, and parallel-group study, conducted according to the 
      German Medical Devices Act, compared the effectiveness and tolerability of ERS09 
      mouth and throat spray with a well-established device for the treatment of sore 
      throat caused by acute pharyngitis and dry cough. Patients were randomised 1:1 
      into ERS09/comparator groups (EMSER((R)) Sore Throat Spray) for 7 +/- 2 days. 
      Patients and investigators reported effectiveness (change in total symptom score 
      [TSS]) and safety endpoints (incidence of adverse events [AEs]; adverse device 
      effects [ADEs]). A total of 186 patients were included (ERS09: n = 92; 
      comparator: n = 94). The baseline-adjusted mean TSS over 7 days was -90.14 and 
      -74.91 in the ERS09 and comparator groups, respectively (p < 0.05). The majority 
      of patients reached a 50% reduction in symptoms by day 6 (ERS09 = 78.85; 
      comparator = 75.8%). Most patients reported a soothing effect within five minutes 
      (ERS09 = 82%; comparator = 71%). Improvements in individual symptoms were similar 
      with no significant differences between groups; more patients in the ERS09 group 
      reported an improvement in pharyngeal redness/swelling. Three AEs unrelated to 
      medication, one ADE following ERS09, and no serious AE/ADE were reported. ERS09 
      was as well tolerated and effective as the established device, showing greater 
      improvement in the management of some symptoms and greater patient preference.
FAU - Roventa, Don Lorenzo Constantin
AU  - Roventa DLC
AD  - Institute of Medical Statistics and Bioinformatics (IMSB), Faculty of Medicine, 
      University of Cologne, 50924 Cologne, Germany.
FAU - Pieper-Furst, Ursula
AU  - Pieper-Furst U
AD  - ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668 Cologne, Germany.
FAU - Acikel, Cengizhan
AU  - Acikel C
AUID- ORCID: 0000-0001-5699-4305
AD  - ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668 Cologne, Germany.
FAU - Santos, Dunia
AU  - Santos D
AUID- ORCID: 0009-0007-3878-1155
AD  - Sanofi, 65926 Frankfurt, Germany.
FAU - Sent, Ulrike
AU  - Sent U
AD  - Sanofi, 65926 Frankfurt, Germany.
FAU - Mosges, Ralph
AU  - Mosges R
AUID- ORCID: 0000-0002-1928-810X
AD  - Institute of Medical Statistics and Bioinformatics (IMSB), Faculty of Medicine, 
      University of Cologne, 50924 Cologne, Germany.
AD  - ClinCompetence Cologne GmbH, Theodor-Heuss-Ring 14, 50668 Cologne, Germany.
LA  - eng
GR  - N/A/Sanofi/
PT  - Journal Article
DEP - 20230907
PL  - Switzerland
TA  - J Clin Med
JT  - Journal of clinical medicine
JID - 101606588
PMC - PMC10531782
OTO - NOTNLM
OT  - acute pharyngitis
OT  - dry cough
OT  - ectoine
OT  - sore throat
OT  - throat spray
OT  - treatment device
COIS- U.S. and D.S. are employees of Sanofi and may hold shares and/or stock options in 
      the company. D.L.C.R., U.P.-F., and C.A. have no relevant financial interests to 
      disclose. R.M. reports personal fees from Sanofi and research funds and 
      non-financial support from Bitop AG during the conduct of the study; personal 
      fees from ALK, research funds from ASIT biotech, personal fees from 
      allergopharma, personal fees from Allergy Therapeutics, research funds and 
      personal fees from Bencard, research funds from Leti, research funds, personal 
      fees, and non-financial support from Lofarma, non-financial support from Roxall, 
      research funds and personal fees from Stallergenes, research funds from Optima, 
      personal fees from Friulchem, personal fees from Hexal, personal fees from 
      Servier, personal fees from Klosterfrau, non-financial support from Atmos, 
      personal fees from Bayer, non-financial support from Bionorica, personal fees 
      from FAES, personal fees from GSK, personal fees from MSD, personal fees from 
      Johnson&Johnson, personal fees from Meda, personal fees and non-financial support 
      from Novartis, non-financial support from Otonomy, personal fees from Stada, 
      personal fees from UCB, non-financial support from Ferrero, research funding from 
      Hulka, personal fees from Nuvo, research funding from Ursapharm, personal fees 
      from Menarini, personal fees from Mundipharma, personal fees from Pohl-Boskamp, 
      and research funding from Inmunotek outside the submitted work.
EDAT- 2023/09/28 06:42
MHDA- 2023/09/28 06:43
PMCR- 2023/09/07
CRDT- 2023/09/28 01:22
PHST- 2023/07/25 00:00 [received]
PHST- 2023/08/31 00:00 [revised]
PHST- 2023/09/04 00:00 [accepted]
PHST- 2023/09/28 06:43 [medline]
PHST- 2023/09/28 06:42 [pubmed]
PHST- 2023/09/28 01:22 [entrez]
PHST- 2023/09/07 00:00 [pmc-release]
AID - jcm12185813 [pii]
AID - jcm-12-05813 [pii]
AID - 10.3390/jcm12185813 [doi]
PST - epublish
SO  - J Clin Med. 2023 Sep 7;12(18):5813. doi: 10.3390/jcm12185813.