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Mometasone furoate delivered via the Breezhaler® and Twisthaler® devices in asthma

Frank Kanniess, Gerald Hanf, Motoi Hosoe, Ana-Marie Tanase, Soniya Vaidya, Rudrani Banerjee, Bettina Hederer
European Respiratory Journal 2014 44: P915; DOI:
Frank Kanniess
1Allergology, Gemeinschaftspraxis Reinfeld, Reinfeld, Germany
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Gerald Hanf
2Department of Internal Medicine, Respiratory and Infectious Diseases, Das UntersuchungsZentrum für Dermatologie, Allergologie und Asthma (UZDAA), Berlin, Germany
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Motoi Hosoe
3Primary Care, Novartis Pharma AG, Basel, Switzerland
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Ana-Marie Tanase
3Primary Care, Novartis Pharma AG, Basel, Switzerland
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Soniya Vaidya
4Primary Care, Novartis Institutes for BioMedical Research, Cambridge,
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Rudrani Banerjee
5Primary Care, Novartis Healthcare Pvt. Ltd., Hyderabad, India
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Bettina Hederer
3Primary Care, Novartis Pharma AG, Basel, Switzerland
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Abstract

Background

QMF149 is an investigational inhaled fixed-dose combination of indacaterol acetate (long-acting β2-agonist) and mometasone furoate (MF, corticosteroid) delivered via the Breezhaler® device for once daily maintenance treatment of asthma and COPD. Since MF doses delivered via the Twisthaler® device are approved in asthma, bridging of MF delivered via the Twisthaler® device to MF delivered via the Breezhaler® device was necessary to ensure comparability between devices.

Objective

To demonstrate non-inferiority of MF delivered via the Breezhaler® device to MF delivered via the Twisthaler® device in trough FEV1 (tFEV1) at Week 4.

Methods

In this double-blind, parallel-group study, 739 asthma patients were randomised to receive one of four treatments (MF Breezhaler® 80 µg, MF Breezhaler® 320 µg, MF Twisthaler® 200 µg, MF Twisthaler® 800 µg) once daily for 4 weeks.

Results

In low dose comparison, LS mean difference of tFEV1 between MF 80 µg and MF 200 µg was 68 mL (p<0.001) with lower limit of 97.5% CI of 0 mL. In high dose comparison, LS mean difference of tFEV1 between MF 320 µg and MF 800 µg was 25 mL (p<0.001) with lower limit of 97.5% CI of –42.7mL. Therefore non-inferiority of MF Breezhaler® to MF Twisthaler® for both low and high doses was demonstrated as lower limit of one-sided 97.5% CI was above pre-defined non-inferiority margin of –90 mL. Mean plasma MF AUC and Cmax were lower for the Breezhaler® doses vs the corresponding Twisthaler® doses. All treatments showed good safety profile.

Conclusion

This study confirms that selected MF doses of 80 µg and 320 µg delivered via the Breezhaler® device are comparable to MF doses of 200 µg and 800 µg delivered via the Twisthaler® device in asthma.

  • Airway management
  • Bronchodilators
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  • © 2014 ERS
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Mometasone furoate delivered via the Breezhaler® and Twisthaler® devices in asthma
Frank Kanniess, Gerald Hanf, Motoi Hosoe, Ana-Marie Tanase, Soniya Vaidya, Rudrani Banerjee, Bettina Hederer
European Respiratory Journal Sep 2014, 44 (Suppl 58) P915;

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Mometasone furoate delivered via the Breezhaler® and Twisthaler® devices in asthma
Frank Kanniess, Gerald Hanf, Motoi Hosoe, Ana-Marie Tanase, Soniya Vaidya, Rudrani Banerjee, Bettina Hederer
European Respiratory Journal Sep 2014, 44 (Suppl 58) P915;
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