Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study.
Respir Res
; 21(1): 87, 2020 Apr 15.
Article
em En
| MEDLINE
| ID: mdl-32295593
ABSTRACT
Indacaterol (IND; 150 µg), glycopyrronium (GLY; 50 µg) and mometasone furoate (MF; 160 µg [high-dose ICS] and 80 µg [medium-dose ICS]) have been formulated as a once-daily (o.d.) fixed-dose combination treatment delivered via the Breezhaler® device for the treatment of patients with asthma. In this randomized (n = 116), double-blind, double-dummy, active comparator-controlled, three-period cross-over study we evaluated the benefit of o.d. IND/GLY/MF versus twice daily (b.i.d.) salmeterol/fluticasone propionate combination (SFC; 50/500 µg; high-dose ICS) treatment (NCT03063086). Overall, 107 patients completed the study. The study met its primary objective by demonstrating superiority of o.d. IND/GLY/MF at medium and high-dose ICS over b.i.d. SFC (high-dose ICS) in peak FEV1 after 21 days of treatment (+ 172 mL with high-dose and + 159 mL with medium-dose IND/GLY/MF versus SFC, p < 0.0001 for each comparison). We also observed that a higher percentage of patients did not need rescue medicine with IND/GLY/MF (high-dose ICS, 58%; medium-dose ICS, 52%) compared with SFC (45%) during the last week of each treatment period. Study treatments were well-tolerated with no relevant differences in tolerability between both IND/GLY/MF doses and SFC. In conclusion, both doses of IND/GLY/MF provided superior lung function benefits compared with twice-daily, standard-of-care SFC at the highest approved dose. TRIAL REGISTRATION ClinicalTrials.gov, (Identifier NCT03063086), EudraCT start date May 11, 2017; First patient first visit / study initiation date May 31, 2017.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Asma
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Broncodilatadores
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Quinolonas
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Combinação Fluticasona-Salmeterol
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Furoato de Mometasona
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Indanos
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Respir Res
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Alemanha