Fixed-dose combination of three drugs, i.e. LABA/LAMA/ICS for COPD: Results of a real-world study from India.


Journal

Pulmonary pharmacology & therapeutics
ISSN: 1522-9629
Titre abrégé: Pulm Pharmacol Ther
Pays: England
ID NLM: 9715279

Informations de publication

Date de publication:
08 2020
Historique:
received: 26 01 2020
revised: 17 06 2020
accepted: 25 07 2020
pubmed: 11 8 2020
medline: 2 9 2021
entrez: 11 8 2020
Statut: ppublish

Résumé

The use of triple therapy with inhaled corticosteroids, long-acting beta-agonist and long-acting antimuscarinics has been shown to be beneficial in COPD patients who continue to have symptoms and exacerbations, despite receiving dual bronchodilator combinations. This study assessed the real-world effectiveness and safety of once-daily, fixed-dose combination of Tiotropium/Formoterol/Ciclesonide (TFC) (18 mcg/12 mcg/400 mcg) via dry powder inhaler (DPI) or metered dose inhaler (MDI) in patients with COPD. In this 24-week, open-label, prospective, non-comparative, multicentre, real-world study, COPD patients requiring triple therapy as judged by their physician, were enrolled. The primary endpoint was mean change from baseline in pre-dose Forced Expiratory Volume in 1 s (FEV Out of the 297 patients enrolled [mean age 61 ± 10 years; 84.8% males; 55.2% smokers and post-dose FEV In this real world, multicentre study in India, TFC significantly improved lung function, symptoms and quality of life among all patients with COPD, but the effect was more pronounced among non-smoker COPD patients.

Sections du résumé

BACKGROUND
The use of triple therapy with inhaled corticosteroids, long-acting beta-agonist and long-acting antimuscarinics has been shown to be beneficial in COPD patients who continue to have symptoms and exacerbations, despite receiving dual bronchodilator combinations. This study assessed the real-world effectiveness and safety of once-daily, fixed-dose combination of Tiotropium/Formoterol/Ciclesonide (TFC) (18 mcg/12 mcg/400 mcg) via dry powder inhaler (DPI) or metered dose inhaler (MDI) in patients with COPD.
PATIENTS AND METHODS
In this 24-week, open-label, prospective, non-comparative, multicentre, real-world study, COPD patients requiring triple therapy as judged by their physician, were enrolled. The primary endpoint was mean change from baseline in pre-dose Forced Expiratory Volume in 1 s (FEV
RESULTS
Out of the 297 patients enrolled [mean age 61 ± 10 years; 84.8% males; 55.2% smokers and post-dose FEV
CONCLUSION
In this real world, multicentre study in India, TFC significantly improved lung function, symptoms and quality of life among all patients with COPD, but the effect was more pronounced among non-smoker COPD patients.

Identifiants

pubmed: 32777289
pii: S1094-5539(20)30136-X
doi: 10.1016/j.pupt.2020.101932
pii:
doi:

Substances chimiques

Bronchodilator Agents 0
Drug Combinations 0
Formoterol Fumarate W34SHF8J2K

Types de publication

Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

101932

Informations de copyright

Copyright © 2020 Elsevier Ltd. All rights reserved.

Auteurs

Sundeep Salvi (S)

Chest Research Foundation, Pune, India.

Ashish Kumar Deb (AK)

Sudbhavana Hospital, Varanasi, India.

Mayank Agarwal (M)

Om Surgical Center & Maternity Home, Varanasi, India.

Venkateswara Reddy Tummuru (VR)

Eesha Multispeciality Hospital, Hyderabad, India.

Rahul Kodgule (R)

Chest Research Foundation, Pune, India.

V S Hemalatha (VS)

Sree Narayana Institute of Medical Sciences, Ernakulam, India.

Anil Kumar Awasthi (AK)

Ajantha Hospitals & IVF Centre Pvt. Ltd., Lucknow, India.

K P Suraj (KP)

Institute of Chest Diseases, Kozhikode, India.

Vinod Kumar Pavitran (VK)

KVM Multispeciality Hospital, Chirtihala, India.

Shashi Prakash Mourya (SP)

Lal Hospital & Heart Centre, Lucknow, India.

Paul Thomas (P)

Madonna Hospital and Research Centre, Ernakulam, India.

Abhijit Vaidya (A)

Cipla Ltd, Mumbai, India.

Sushmeeta Chhowala (S)

Cipla Ltd, Mumbai, India. Electronic address: sushmeeta@cipla.com.

Jaideep Gogtay (J)

Cipla Ltd, Mumbai, India.

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Classifications MeSH