TRICOP - A Real-world effectiveness study with a single-inhaler extrafine triple therapy over 52 weeks in Austrian patients with COPD
Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved..
OBJECTIVE: Evidence of the efficacy of single-inhaler triple therapy in COPD patients inferred from RCTs has not been assessed in a real-world setting in Austria. In this non-interventional study (NIS) tolerability and effectiveness of extrafine beclometasone-dipropionate, formoterol-fumarate and glycopyrronium (Trimbow® 87/5/9 μg) was evaluated in COPD patients.
METHODS: A prospective NIS was conducted over 52 weeks in 24 sites in Austria. Eligible COPD patients had an indication for treatment with single-inhaler BDP/FF/G. In this study tolerability, lung function, exacerbation rate, symptom scores and CAT scores were recorded.
RESULTS: 265 patients with moderate to very severe airflow limitation (GOLD Grade 2-4: 96.2%) and persistent symptoms (GOLD B: 62.3%, GOLD D: 34%) according to the 2018 GOLD Report were included. After 52 weeks, a significant improvement was detected in lung function (FEV1, FEV1% predicted and FVC; p < 0.001) and symptoms (cough, sputum and shortness of breath; p < 0.001). A clinically relevant improvement in CAT score observed at 12 weeks persisted after 52 weeks in GOLD B and GOLD D patients (p < 0.001), paralleled by a significant reduction of moderate and severe exacerbations by 57.4% and 27.3%, respectively (p < 0.001). After 52 weeks, 93.7% of the patients continued the treatment. Of 21 adverse events reported 16 were non-serious, five were serious, none were deemed drug related.
CONCLUSIONS: The present results support the tolerability and effectiveness of extrafine BDP/FF/G in COPD patients in a real-world setting, showing an improvement in lung function, symptom control and a significant reduction in exacerbations.
Medienart: |
E-Artikel |
---|
Erscheinungsjahr: |
2021 |
---|---|
Erschienen: |
2021 |
Enthalten in: |
Zur Gesamtaufnahme - volume:182 |
---|---|
Enthalten in: |
Respiratory medicine - 182(2021) vom: 01. Juni, Seite 106398 |
Sprache: |
Englisch |
---|
Beteiligte Personen: |
Marth, Katharina [VerfasserIn] |
---|
Links: |
---|
Anmerkungen: |
Date Completed 14.12.2021 Date Revised 14.12.2021 published: Print-Electronic Citation Status MEDLINE |
---|
doi: |
10.1016/j.rmed.2021.106398 |
---|
funding: |
|
---|---|
Förderinstitution / Projekttitel: |
|
PPN (Katalog-ID): |
NLM324552793 |
---|
LEADER | 01000naa a22002652 4500 | ||
---|---|---|---|
001 | NLM324552793 | ||
003 | DE-627 | ||
005 | 20231225190549.0 | ||
007 | cr uuu---uuuuu | ||
008 | 231225s2021 xx |||||o 00| ||eng c | ||
024 | 7 | |a 10.1016/j.rmed.2021.106398 |2 doi | |
028 | 5 | 2 | |a pubmed24n1081.xml |
035 | |a (DE-627)NLM324552793 | ||
035 | |a (NLM)33901786 | ||
035 | |a (PII)S0954-6111(21)00104-9 | ||
040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
041 | |a eng | ||
100 | 1 | |a Marth, Katharina |e verfasserin |4 aut | |
245 | 1 | 0 | |a TRICOP - A Real-world effectiveness study with a single-inhaler extrafine triple therapy over 52 weeks in Austrian patients with COPD |
264 | 1 | |c 2021 | |
336 | |a Text |b txt |2 rdacontent | ||
337 | |a ƒaComputermedien |b c |2 rdamedia | ||
338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
500 | |a Date Completed 14.12.2021 | ||
500 | |a Date Revised 14.12.2021 | ||
500 | |a published: Print-Electronic | ||
500 | |a Citation Status MEDLINE | ||
520 | |a Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved. | ||
520 | |a OBJECTIVE: Evidence of the efficacy of single-inhaler triple therapy in COPD patients inferred from RCTs has not been assessed in a real-world setting in Austria. In this non-interventional study (NIS) tolerability and effectiveness of extrafine beclometasone-dipropionate, formoterol-fumarate and glycopyrronium (Trimbow® 87/5/9 μg) was evaluated in COPD patients | ||
520 | |a METHODS: A prospective NIS was conducted over 52 weeks in 24 sites in Austria. Eligible COPD patients had an indication for treatment with single-inhaler BDP/FF/G. In this study tolerability, lung function, exacerbation rate, symptom scores and CAT scores were recorded | ||
520 | |a RESULTS: 265 patients with moderate to very severe airflow limitation (GOLD Grade 2-4: 96.2%) and persistent symptoms (GOLD B: 62.3%, GOLD D: 34%) according to the 2018 GOLD Report were included. After 52 weeks, a significant improvement was detected in lung function (FEV1, FEV1% predicted and FVC; p < 0.001) and symptoms (cough, sputum and shortness of breath; p < 0.001). A clinically relevant improvement in CAT score observed at 12 weeks persisted after 52 weeks in GOLD B and GOLD D patients (p < 0.001), paralleled by a significant reduction of moderate and severe exacerbations by 57.4% and 27.3%, respectively (p < 0.001). After 52 weeks, 93.7% of the patients continued the treatment. Of 21 adverse events reported 16 were non-serious, five were serious, none were deemed drug related | ||
520 | |a CONCLUSIONS: The present results support the tolerability and effectiveness of extrafine BDP/FF/G in COPD patients in a real-world setting, showing an improvement in lung function, symptom control and a significant reduction in exacerbations | ||
650 | 4 | |a Journal Article | |
650 | 4 | |a Research Support, Non-U.S. Gov't | |
650 | 4 | |a Beclometasone | |
650 | 4 | |a COPD | |
650 | 4 | |a Extrafine particles | |
650 | 4 | |a Formoterol | |
650 | 4 | |a Glycopyrronium | |
650 | 4 | |a Triple inhaled therapy | |
650 | 7 | |a Beclomethasone |2 NLM | |
650 | 7 | |a KGZ1SLC28Z |2 NLM | |
650 | 7 | |a Glycopyrrolate |2 NLM | |
650 | 7 | |a V92SO9WP2I |2 NLM | |
650 | 7 | |a Formoterol Fumarate |2 NLM | |
650 | 7 | |a W34SHF8J2K |2 NLM | |
700 | 1 | |a Renner, Andreas |e verfasserin |4 aut | |
700 | 1 | |a Pohl, Wolfgang |e verfasserin |4 aut | |
773 | 0 | 8 | |i Enthalten in |t Respiratory medicine |d 1993 |g 182(2021) vom: 01. Juni, Seite 106398 |w (DE-627)NLM012605247 |x 1532-3064 |7 nnns |
773 | 1 | 8 | |g volume:182 |g year:2021 |g day:01 |g month:06 |g pages:106398 |
856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.rmed.2021.106398 |3 Volltext |
912 | |a GBV_USEFLAG_A | ||
912 | |a GBV_NLM | ||
951 | |a AR | ||
952 | |d 182 |j 2021 |b 01 |c 06 |h 106398 |