A randomized controlled trial of long-acting muscarinic antagonist and long-acting β2 agonist fixed-dose combinations in patients with chronic obstructive pulmonary disease

Autor: Yuji Tohda, Hirochiyo Sawaguchi, Soichiro Hanada, Masato Muraki, Yuki Kunita, Ken Shirahase, Ryo Yamazaki
Rok vydání: 2021
Předmět:
Male
Quinuclidines
Tiotropium/olodaterol
law.invention
Pulmonary Disease
Chronic Obstructive
chemistry.chemical_compound
0302 clinical medicine
Japan
Randomized controlled trial
law
Forced Expiratory Volume
Respiratory function
Prospective Studies
030212 general & internal medicine
Aged
80 and over
Inhaler device
Umeclidinium/vilanterol
COPD
Cross-Over Studies
Olodaterol
Middle Aged
Drug Combinations
Treatment Outcome
Disease Progression
Female
Vilanterol
Research Article
medicine.drug
Quality of life
Pulmonary and Respiratory Medicine
medicine.medical_specialty
Muscarinic Antagonists
Drug Administration Schedule
03 medical and health sciences
Internal medicine
medicine
Humans
Tiotropium Bromide
Adrenergic beta-2 Receptor Agonists
Aged
lcsh:RC705-779
Glycopyrronium/indacaterol
business.industry
Nebulizers and Vaporizers
lcsh:Diseases of the respiratory system
medicine.disease
Crossover study
Benzoxazines
Clinical trial
030228 respiratory system
chemistry
Indacaterol
business
Zdroj: BMC Pulmonary Medicine, Vol 21, Iss 1, Pp 1-8 (2021)
BMC Pulmonary Medicine
ISSN: 1471-2466
Popis: Background In chronic obstructive pulmonary disease (COPD) patients, combination treatment with long-acting muscarinic antagonist (LAMA) and long-acting β2 agonist (LABA) increases forced expiratory volume in one second and reduces symptoms compared to monotherapy. In Japan, three different once-daily fixed-dose combinations (FDCs) have been prescribed since 2015, although a direct comparison of these FDCs has never been performed. The objective of the present study was to compare the effectiveness, preference, and safety of three LAMA/LABA FDCs—glycopyrronium/indacaterol (Gly/Ind), umeclidinium/vilanterol (Ume/Vil), and tiotropium/olodaterol (Tio/Olo)—in patients with COPD. Methods We enrolled 75 COPD outpatients (male:female ratio, 69:6; 77.4 ± 6.9 years). A prospective, randomized, crossover study was conducted on three groups using three FDCs: Gly/Ind; Ume/Vil; and Tio/Olo. Each medication was administered for 4 weeks before crossover (total 12 weeks). After each FDC administration, a respiratory function test and questionnaire survey were conducted. A comparative questionnaire survey of all three LAMA/LABA FDCs was conducted after 12 weeks (following administration of final FDC). Results No significant differences in COPD Assessment Test or modified Medical Research Council dyspnea questionnaire were reported in the surveys completed after each FDC administration; no significant differences in spirometric items were observed. In the final comparative questionnaire survey, patients reported better actual feeling of being able to inhale following Gly/Ind administration compared with Tio/Olo, although no significant differences in adverse events or other evaluations were reported. Conclusions The three LAMA/LABA FDCs administered to COPD patients show similar effects and safety, although some minor individual preference was reported. Trial registration This study retrospectively registered with the University Hospital Medical Information Network Clinical Trials Registry (number UMIN000041342, registered on August 6, 2020).
Databáze: OpenAIRE
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