Pneumologie 2020; 74(S 01): 29
DOI: 10.1055/s-0039-3403123
Posterbegehung (PO03) – Sektion Klinische Pneumologie
Neues zum Asthma bronchiale – Schwerpunkt schweres Asthma
Georg Thieme Verlag KG Stuttgart · New York

Mometasone furoate delivered via Breezhaler® and Twisthaler® in patients with asthma

Authors

  • R Buhl

    1   Johannes Gutenberg University of Mainz

  • AM Tanase

    2   Novartis Pharma AG

  • M Hosoe

    2   Novartis Pharma AG

  • W Cao

    3   Novartis Pharmaceuticals Corporation

  • I Demin

    2   Novartis Pharma AG

  • C Bartels

    2   Novartis Pharma AG

  • J Jauernig

    2   Novartis Pharma AG

  • D Ziegler

    2   Novartis Pharma AG

  • F Patalano

    2   Novartis Pharma AG

  • B Hederer

    4   Novartis Institutes for Biomedical Research

  • F Kannies

    5   Gemeinschaftspraxis Reinfeld

  • HC Tillmann

    4   Novartis Institutes for Biomedical Research
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Publikationsverlauf

Publikationsdatum:
28. Februar 2020 (online)

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Introduction: Mometasone furoate (MF), an inhaled corticosteroid (ICS), is approved for the treatment of asthma. Previous studies suggest that MF Twisthaler® doses of 800 and 200 µg and MF Breezhaler® doses of 320 and 80 µg would elicit similar lung function effects, respectively. These MF doses are also used in an indacaterol/MF combination in development for asthma. Since sensitivity to ICS is variable, individual patientsʼ ICS sensitivity (as measured by FEV1 decline on ICS weaning) was used to build a robust analysis model for the study data.

Methods: This was a randomized, double-blind, double-dummy, parallel-group, non-inferiority study of 739 adolescents and adults with asthma. MF was delivered with Breezhaler® at daily doses of 80 and 320 µg and corresponding Twisthaler® doses of 200 and 800 µg. The primary endpoint was trough FEV1 on Day 29 (non-inferiority margin: − 90 mL). Models with and without ICS sensitivity at baseline were used to analyze the data.

Results: In the model with ICS sensitivity the least squares (LS) mean difference (Δ) in trough FEV1 between MF 80 µg Breezhaler® and MF 200 µg Twisthaler® was 27 mL (95% CI − 34, 89); for MF 320 µg Breezhaler® and MF 800 µg Twisthaler® Δ was 0 mL (95% CI − 60, 61). In the model without ICS sensitivity Δ between MF 80 µg Breezhaler® and MF 200 µg Twisthaler® patients was 68 mL (0, 137) and 25 mL (− 43, 92) between MF 320 µg Breezhaler® and MF 800 µg Twisthaler®. Model diagnostics showed that using ICS sensitivity as a covariate improved the model.

Conclusion: MF 80 and 320 µg, delivered via Breezhaler®, is non-inferior to MF at 200 and 800 µg, delivered via Twisthaler®. Including ICS sensitivity in the model improves model robustness.