Switzerland-based Novartis has revealed the first study results from the phase III PLATINUM clinical development program evaluating the safety and efficacy of QMF149, an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol acetate (IND - a long acting beta agonist [LABA]) and mometasone furoate (MF - an anti-inflammatory (ICS), it was reported yesterday.
In this multicentre, randomised, double-blind phase III QUARTZ study (ClinicalTrials.gov Identifier: NCT02892344), once-daily, low dose IND/MF (QMF149) 150/80 Mu g met the primary and key secondary endpoints (trough FEV1 and ACQ-7 score at Week 12, respectively) when compared to once-daily mometasone furoate, an ICS, delivered through the Twisthaler device (200 Mu g) in both adult and adolescent patients with asthma.
Patients included in the QUARTZ study were inadequately controlled (symptomatic as defined by Asthma Control Questionnaire, ACQ-7>1.5) on low dose ICS (with or without an additional maintenance treatment).
Linda Armstrong, MD, Respiratory Development Unit head, said, 'Despite the number of available treatments, many patients' lives remain impacted by their asthma. The QMF149 results of the QUARTZ study complement the recently presented phase II data of QVM149 at the 2019 American Thoracic Society Congress, showing superiority of QVM149 to the current standard of care. We look forward to seeing the rest of the data from the PLATINUM clinical trial program.'
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