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Letter to the editor : Indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: A randomized controlled cross-over study

Watz, Henrik ; Hohlfeld, Jens M. ; Singh, Dave ; Beier, Jutta ; Diamant, Zuzana LU ; Liu, Jinming ; Hua, Shucheng ; Abd-Elaziz, Khalid ; Pinot, Pascale and Jones, Ieuan , et al. (2020) In Respiratory Research 21(1).
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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Asthma, Glycopyrronium, Indacaterol, Mometasone Furoate
in
Respiratory Research
volume
21
issue
1
article number
87
publisher
BioMed Central (BMC)
external identifiers
  • scopus:85083478026
  • pmid:32295593
ISSN
1465-9921
DOI
10.1186/s12931-020-01349-5
language
English
LU publication?
yes
id
4b0e1882-7817-4839-b2de-6781e5432106
date added to LUP
2020-04-30 10:03:30
date last changed
2025-04-04 14:16:37
@article{4b0e1882-7817-4839-b2de-6781e5432106,
  abstract     = {{<p>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 FEV<sub>1</sub> after 21 days of treatment (+ 172 mL with high-dose and + 159 mL with medium-dose IND/GLY/MF versus SFC, p &lt; 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.</p>}},
  author       = {{Watz, Henrik and Hohlfeld, Jens M. and Singh, Dave and Beier, Jutta and Diamant, Zuzana and Liu, Jinming and Hua, Shucheng and Abd-Elaziz, Khalid and Pinot, Pascale and Jones, Ieuan and Tillmann, Hanns Christian}},
  issn         = {{1465-9921}},
  keywords     = {{Asthma; Glycopyrronium; Indacaterol; Mometasone Furoate}},
  language     = {{eng}},
  month        = {{04}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Respiratory Research}},
  title        = {{Letter to the editor : Indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: A randomized controlled cross-over study}},
  url          = {{http://dx.doi.org/10.1186/s12931-020-01349-5}},
  doi          = {{10.1186/s12931-020-01349-5}},
  volume       = {{21}},
  year         = {{2020}},
}