PMID- 35348408
OWN - NLM
STAT- MEDLINE
DCOM- 20230228
LR  - 20230331
IS  - 1532-4303 (Electronic)
IS  - 0277-0903 (Linking)
VI  - 60
IP  - 2
DP  - 2023 Feb
TI  - Long-term safety of once-daily indacaterol acetate/glycopyrronium 
      bromide/mometasone furoate high-dose, and indacaterol acetate/mometasone furoate 
      high-dose, in Japanese patients with inadequately controlled asthma: Results from 
      two open-label, 52-week studies.
PG  - 403-411
LID - 10.1080/02770903.2022.2056048 [doi]
AB  - INTRODUCTION: The 52-week long-term safety of once-daily indacaterol 
      acetate/glycopyrronium bromide/mometasone furoate (IND/GLY/MF) high-dose 
      (150/50/160 microg) and IND/MF high-dose (150/320 microg) was evaluated in two studies 
      enrolling Japanese patients with inadequately controlled asthma. METHODS: Study 1 
      (IND/GLY/MF) and Study 2 (IND/MF) were 52-week, phase III, open-label, 
      single-arm, multicenter studies conducted in Japanese adult patients with 
      inadequately controlled asthma. The primary endpoint was incidence and severity 
      of treatment-emergent adverse events (AEs) over 52-weeks. RESULTS: In Study 1, 94 
      patients received IND/GLY/MF high-dose and 84 (89.4%) patients completed the 
      52-week study treatment; in Study 2, 51 patients received IND/MF high-dose and 48 
      (94.1%) patients completed the 52-week study treatment. In Study 1, 68.1% and 
      6.4% of 94 patients reported >/=1 AE and >/=1 serious AE (SAE) respectively. In Study 
      2, 78.4% of 51 patients reported >/=1 AE; no patients reported SAEs. The most 
      commonly reported AEs were asthma (exacerbation; 30.9% and 54.9%) and 
      nasopharyngitis (18.1% and 29.4%) in Study 1 and Study 2, respectively. Severe 
      AEs including asthma (exacerbation) were reported in 13.8% and 13.7% of patients 
      in Study 1 and Study 2, respectively. In Study 1, 10 patients (10.6%) reported 
      treatment-related AEs, of which dysphonia (9 patients [9.6%]) was the most 
      commonly reported; no treatment-related AEs were reported in Study 2. In Study 1, 
      one death (not study drug-related) was reported after study discontinuation 
      (92 days after last dose of study medication). CONCLUSIONS: Once-daily IND/GLY/MF 
      and IND/MF high-dose were well-tolerated in Japanese patients with inadequately 
      controlled asthma. No unexpected safety findings were observed. Supplemental data 
      for this article is available online at.
FAU - Sagara, Hironori
AU  - Sagara H
AD  - Department of Medicine, Division of Respiratory Medicine and Allergology, Showa 
      University, School of Medicine, Tokyo, Japan.
FAU - D'Andrea, Peter
AU  - D'Andrea P
AD  - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
FAU - Tanase, Ana-Maria
AU  - Tanase AM
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Pethe, Abhijit
AU  - Pethe A
AD  - Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
FAU - Tanaka, Yukina
AU  - Tanaka Y
AD  - Novartis Pharma K.K, Tokyo, Japan.
FAU - Matsuo, Kazutaka
AU  - Matsuo K
AD  - Novartis Pharma K.K, Tokyo, Japan.
FAU - Hosoe, Motoi
AU  - Hosoe M
AD  - Novartis Pharma AG, Basel, Switzerland.
FAU - Nakamura, Yoichi
AU  - Nakamura Y
AD  - Department of Allergology, Medical Center for Allergy and Immune Diseases, 
      Yokohama City Minato Red Cross Hospital, Kanagawa, Japan.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20220530
PL  - England
TA  - J Asthma
JT  - The Journal of asthma : official journal of the Association for the Care of 
      Asthma
JID - 8106454
RN  - 0 (Acetates)
RN  - 0 (Adrenergic beta-2 Receptor Agonists)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Drug Combinations)
RN  - V92SO9WP2I (Glycopyrrolate)
RN  - 8OR09251MQ (indacaterol)
RN  - 04201GDN4R (Mometasone Furoate)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Acetates/therapeutic use
MH  - Administration, Inhalation
MH  - Adrenergic beta-2 Receptor Agonists/therapeutic use
MH  - *Asthma/drug therapy
MH  - Bronchodilator Agents/therapeutic use
MH  - Drug Combinations
MH  - East Asian People
MH  - Glycopyrrolate/therapeutic use
MH  - *Mometasone Furoate/therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Asthma control
OT  - Japan
OT  - long-acting beta2-adrenergic agonist/inhaled corticosteroid (LABA/ICS)
OT  - long-acting beta2-adrenergic agonist/long-acting muscarinic antagonist/inhaled 
      corticosteroid (LABA/LAMA/ICS)
OT  - lung function
OT  - safety
EDAT- 2022/03/30 06:00
MHDA- 2023/03/03 06:00
CRDT- 2022/03/29 12:19
PHST- 2022/03/30 06:00 [pubmed]
PHST- 2023/03/03 06:00 [medline]
PHST- 2022/03/29 12:19 [entrez]
AID - 10.1080/02770903.2022.2056048 [doi]
PST - ppublish
SO  - J Asthma. 2023 Feb;60(2):403-411. doi: 10.1080/02770903.2022.2056048. Epub 2022 
      May 30.