Pneumologie 2020; 74(S 01): 46
DOI: 10.1055/s-0039-3403165
Posterbegehung (PO08) – Sektion Klinische Pneumologie
Klinische Studien bei COPD und Asthma
Georg Thieme Verlag KG Stuttgart · New York

Lung function normalization with indacaterol/glycopyrronium/mometasone furoate in patients with asthma

K Chapman
1   University of Toronto
,
H Watz
2   Pulmonary Research Institute at Lungenclinic Grosshansdorf
,
J Beier
3   Insaf Respiratory Research Institute
,
D Singh
4   University of Manchester
,
J Hohlfeld
5   Frauenhofer Institute Hannover Medical School
,
Z Diamant
6   Skane University Hospital Lund University
,
V Scholz
7   Charité Research Organisation
,
A Sarkar
8   Sandoz Biopharmaceuticals
,
I Jones
9   Novartis Pharma AG
,
R Li
10   Novartis Institutes for Biomedical Research
,
P Pinot
10   Novartis Institutes for Biomedical Research
,
HC Tillmann
10   Novartis Institutes for Biomedical Research
› Author Affiliations
Further Information

Publication History

Publication Date:
28 February 2020 (online)

Also available at
 
 

    Introduction: Indacaterol (IND, LABA), glycopyrronium (GLY, LAMA) and mometasone furoate (MF, ICS) have been formulated as a once-daily (o. d.) fixed-dose combination therapy (IND/GLY/MF) delivered via the Breezhaler® device for the treatment of asthma. We report data from two Phase II studies (B2208 and B2209).

    Methods: Both studies had a randomized, double-blind, 3-period crossover design.

    B2208 included 116 adult patients with moderate-to-severe asthma (on LABA/ICS, FEV1%predicted < 80%), comparing IND/GLY/MF o. d. 150/50/160 µg (high-dose ICS) and 150/50/80 μg (medium-dose ICS) with twice-daily high-dose salmeterol/fluticasone (S/F [LABA/ICS], 50/500 µg) over 21 days.

    B2209 included 37 adult patients with mild-to-moderate asthma (on low- or medium-dose ICS, FEV1%predicted ≥ 60 −<100%), comparing medium-dose IND/GLY/MF with placebo over 14 days.

    Results: In B2208, 44.6% and 47.3% of patients on high- or medium-dose IND/GLY/MF, respectively, achieved near-normal lung function (FEV1 [AUC 0 – 24h] ≥ 80% of predicted normal) compared with 34.4% with S/F (p < 0.05 for both comparisons). In B2209, 48.4% of patients on medium-dose IND/GLY/MF achieved normal lung function (FEV1 [AUC 0 – 24h] ≥ 90% of predicted normal) vs. 6.7% on placebo. The odds ratio (OR) (95% CI) of being rescue medication free was 1.87 (1.03, 3.41) and 1.44 (0.80, 2.59) when treated with high- or medium-dose IND/GLY/MF, respectively, compared with S/F (B2208). The OR (95% CI) was 11.51 (3.77, 35.14) for medium-dose IND/GLY/MF vs. placebo (B2209).

    Conclusion: Patients with asthma are more likely to achieve normal or near-normal lung function and to remain rescue medication free with IND/GLY/MF compared with high-dose S/F or placebo.


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