PMID- 35752582
OWN - NLM
STAT- MEDLINE
DCOM- 20220928
LR  - 20220928
IS  - 1440-1592 (Electronic)
IS  - 1323-8930 (Linking)
VI  - 71
IP  - 4
DP  - 2022 Oct
TI  - A phase 3, randomized, double-blind, clinical study to evaluate the long-term 
      safety and efficacy of gefapixant in Japanese adult participants with refractory 
      or unexplained chronic cough.
PG  - 498-504
LID - S1323-8930(22)00047-8 [pii]
LID - 10.1016/j.alit.2022.05.006 [doi]
AB  - BACKGROUND: In two phase 3, global clinical trials (COUGH-1 and COUGH-2), the 
      P2X3-receptor antagonist gefapixant significantly reduced objective 24-h cough 
      frequency in participants with refractory or unexplained chronic cough (RCC or 
      UCC) at a dosage of 45 mg twice daily (BID), with an acceptable safety profile. 
      The primary objective of this phase 3, randomized, double-blind, parallel-group 
      study was to assess the safety and tolerability of gefapixant in Japanese 
      participants with RCC or UCC (ClinicalTrials.gov, NCT03696108; JAPIC-CTI, 
      184154). METHODS: Participants aged >/=20 years with chronic cough lasting >/=4 
      months and a diagnosis of RCC or UCC despite treatment in accordance with 
      Japanese Respiratory Society guidelines were randomized 1:1 to receive gefapixant 
      15 or 45 mg BID for 52 weeks. The primary objective was to evaluate the safety 
      and tolerability of gefapixant, including adverse events (AEs) and 
      discontinuations due to AEs. Cough-specific quality of life was assessed using 
      the Leicester Cough Questionnaire as a secondary objective. RESULTS: Of 169 
      randomized and treated participants, 63% were female and mean age was 58 years. 
      Adverse events were reported by 79 (94%) and 82 (96%) participants in the 15- and 
      45-mg BID groups, respectively. Most treatment-related AEs were taste related. 
      Discontinuations due to AEs occurred in 6 (7%) and 17 (20%) participants 
      receiving gefapixant 15 or 45 mg BID, respectively. There were no serious 
      treatment-related AEs or deaths. Leicester Cough Questionnaire total scores 
      improved from baseline through Week 52. CONCLUSIONS: Gefapixant had an acceptable 
      safety profile, with no serious treatment-related AEs in Japanese participants.
CI  - Copyright (c) 2022 Japanese Society of Allergology. Production and hosting by 
      Elsevier B.V. All rights reserved.
FAU - Niimi, Akio
AU  - Niimi A
AD  - Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City 
      University Graduate School of Medical Sciences, Nagoya, Japan.
FAU - Sagara, Hironori
AU  - Sagara H
AD  - Department of Medicine, Division of Respiratory Medicine and Allergology, Showa 
      University School of Medicine, Tokyo, Japan.
FAU - Kikuchi, Masashi
AU  - Kikuchi M
AD  - MSD K.K., Tokyo, Japan. Electronic address: masashi.kikuchi@merck.com.
FAU - Arano, Ichiro
AU  - Arano I
AD  - MSD K.K., Tokyo, Japan.
FAU - Sato, Asako
AU  - Sato A
AD  - MSD K.K., Tokyo, Japan.
FAU - Shirakawa, Masayoshi
AU  - Shirakawa M
AD  - MSD K.K., Tokyo, Japan.
FAU - La Rosa, Carmen
AU  - La Rosa C
AD  - Merck & Co., Inc., Rahway, NJ, USA.
FAU - Muccino, David
AU  - Muccino D
AD  - Merck & Co., Inc., Rahway, NJ, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03696108
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20220623
PL  - England
TA  - Allergol Int
JT  - Allergology international : official journal of the Japanese Society of 
      Allergology
JID - 9616296
RN  - 0 (Pyrimidines)
RN  - 0 (Sulfonamides)
RN  - 6K6L7E3F1L (Gefapixant)
SB  - IM
MH  - Adult
MH  - *Carcinoma, Renal Cell
MH  - Chronic Disease
MH  - Cough/drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Japan/epidemiology
MH  - *Kidney Neoplasms
MH  - Male
MH  - Middle Aged
MH  - Pyrimidines
MH  - Quality of Life
MH  - Sulfonamides
OTO - NOTNLM
OT  - Antitussive agents
OT  - Cough
OT  - Gefapixant
OT  - Quality of life
OT  - Safety
EDAT- 2022/06/26 06:00
MHDA- 2022/09/28 06:00
CRDT- 2022/06/25 22:07
PHST- 2022/01/26 00:00 [received]
PHST- 2022/05/04 00:00 [revised]
PHST- 2022/05/10 00:00 [accepted]
PHST- 2022/06/26 06:00 [pubmed]
PHST- 2022/09/28 06:00 [medline]
PHST- 2022/06/25 22:07 [entrez]
AID - S1323-8930(22)00047-8 [pii]
AID - 10.1016/j.alit.2022.05.006 [doi]
PST - ppublish
SO  - Allergol Int. 2022 Oct;71(4):498-504. doi: 10.1016/j.alit.2022.05.006. Epub 2022 
      Jun 23.