PMID- 36965590
OWN - NLM
STAT- MEDLINE
DCOM- 20230501
LR  - 20230503
IS  - 1532-3064 (Electronic)
IS  - 0954-6111 (Linking)
VI  - 212
DP  - 2023 Jun
TI  - "Extrafine single inhaler triple therapy effect on health status, lung function 
      and adherence in COPD patients: A Panhellenic prospective non-interventional 
      study - The TRIBUNE study".
PG  - 107219
LID - S0954-6111(23)00107-5 [pii]
LID - 10.1016/j.rmed.2023.107219 [doi]
AB  - The extrafine single inhaler triple therapy (efSITT) containing beclometasone 
      dipropionate/formoterol fumarate/glycopyrronium 87/5/9 mug has proved to be 
      efficacious in patients with Chronic Obstructive Pulmonary Disease (COPD) in 
      randomized control trials. TRIBUNE study aimed to assess the efSITT effectiveness 
      on health status, lung function, adherence and rescue medication use in COPD 
      patients in Greece in a real-world setting. This was a 24-week prospective, 
      multicenter, observational study in 1,195 patients with moderate/severe COPD and 
      history of at least one exacerbation during the previous year despite dual 
      therapy. Health status (COPD Assessment Test/CAT), lung function parameters and 
      rescue medication use were recorded at baseline, 3 (Visit 2/V2) and 6 months 
      (Visit 3/V3) after treatment. Adherence (Test of Adherence to Inhalers/TAI) and 
      self-reported overall impression of health condition change (Visual Analogue 
      Scale/VAS) were recorded at V2 and V3. Mean CAT score decreased from 20.9 points 
      at V1, to 15.1 at V2 and 13 at V3 (p < 0.001, all pair comparisons). 85.9% of 
      patients achieved a CAT decrease of minimal clinically important difference 
      (MCID) or more (>/=2) at V3, compared to V1. Mean FEV1 increased from 1.4 +/- 0.5 L 
      on V1, to 1.6 +/- 0.5 L on V3 (p < 0.001, N = 275). The percentage of patients with 
      "good adherence" increased from 58.4% (V2) to 64.0% (V3). Rescue medication use 
      and VAS also significantly improved. The efSITT achieves improved outcomes on 
      health status, lung function and rescue medication use as well as satisfactory 
      adherence and patient-reported improvement of health condition, in 
      moderate/severe COPD patients previously treated with a dual combination in a 
      Greek real-world setting.
CI  - Copyright (c) 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Porpodis, Konstantinos
AU  - Porpodis K
AD  - Department of Respiratory Medicine, Aristotle University of Thessaloniki, George 
      Papanikolaou Hospital, 57010, Thessaloniki, Greece.
FAU - Bartziokas, Konstantinos
AU  - Bartziokas K
AD  - Private Sector, 42131, Trikala, Greece.
FAU - Chatziapostolou, Panagiotis
AU  - Chatziapostolou P
AD  - Pulmonary Clinic, Euromedica General Clinic of Thessaloniki, 54645, Thessaloniki, 
      Greece.
FAU - Korkontzelou, Aliki
AU  - Korkontzelou A
AD  - Chiesi Hellas S.A., 17455, Alimos, Greece. Electronic address: 
      a.korkontzelou@chiesi.com.
FAU - Katerelos, Panos
AU  - Katerelos P
AD  - BioStatistics PC, 11474, Athens, Greece.
FAU - Efstathopoulos, Petros
AU  - Efstathopoulos P
AD  - Chiesi Hellas S.A., 17455, Alimos, Greece.
FAU - Bakakos, Petros
AU  - Bakakos P
AD  - 1st University Department of Respiratory Medicine, Medical School, National and 
      Kapodistrian University of Athens, "Sotiria" Chest Diseases Hospital, 11527, 
      Athens, Greece.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20230323
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Adrenergic beta-2 Receptor Agonists)
RN  - W34SHF8J2K (Formoterol Fumarate)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Drug Combinations)
SB  - IM
MH  - Humans
MH  - Prospective Studies
MH  - *Adrenergic beta-2 Receptor Agonists/therapeutic use
MH  - Administration, Inhalation
MH  - Forced Expiratory Volume
MH  - Formoterol Fumarate/pharmacology
MH  - *Pulmonary Disease, Chronic Obstructive/drug therapy
MH  - Nebulizers and Vaporizers
MH  - Lung
MH  - Health Status
MH  - Bronchodilator Agents/therapeutic use
MH  - Drug Combinations
OTO - NOTNLM
OT  - Adherence
OT  - COPD
OT  - Extrafine
OT  - Health status
OT  - Real-world
OT  - Single inhaler triple therapy
COIS- Declaration of competing interest The authors have the following to declare: 
      Konstantinos Porpodis reports no conflict of interest. Konstantinos Bartziokas 
      reports no conflict of interest. Panagiotis Chatziapostolou reports financial 
      support as principal investigator of this study by Chiesi Hellas S.A. Petros 
      Efstathopoulos and Aliki Korkontzelou are employed by Chiesi Hellas S.A. Panos 
      Katerelos reports financial support as statistical analyst of the present study. 
      Petros Bakakos has nothing to declare in terms of the present study.
EDAT- 2023/03/26 06:00
MHDA- 2023/05/01 06:41
CRDT- 2023/03/25 20:28
PHST- 2022/12/20 00:00 [received]
PHST- 2023/03/08 00:00 [revised]
PHST- 2023/03/16 00:00 [accepted]
PHST- 2023/05/01 06:41 [medline]
PHST- 2023/03/26 06:00 [pubmed]
PHST- 2023/03/25 20:28 [entrez]
AID - S0954-6111(23)00107-5 [pii]
AID - 10.1016/j.rmed.2023.107219 [doi]
PST - ppublish
SO  - Respir Med. 2023 Jun;212:107219. doi: 10.1016/j.rmed.2023.107219. Epub 2023 Mar 
      23.