Obstructive Lung Diseases |

A Novel Study Design for the Comparison Between Once-Daily QVA149 and Twice-Daily Salmeterol/Fluticasone on the Reduction of COPD Exacerbations: The FLAME Study FREE TO VIEW

Jadwiga Wedzicha, MD; Jørgen Vestbo, MD; Nicola Gallagher, PhD; Donald Banerji, MD
Author and Funding Information

Department of Academic Respiratory Medicine, University College London, Royal Free Campus, London, United Kingdom

Chest. 2014;145(3_MeetingAbstracts):408A. doi:10.1378/chest.1824340
Text Size: A A A
Published online



SESSION TYPE: Poster Presentations

PRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PM

PURPOSE: Current COPD treatment guidelines recommend long-acting β2-agonist/inhaled corticosteroids (LABA/ICS) for severe COPD patients with a history of exacerbations. The 26-week ILLUMINATE study in moderate-to-severe COPD patients showed superiority of QVA149 versus the LABA/ICS salmeterol/fluticasone combination (SFC) in lung function. A novel study design to evaluate the effect of QVA149 versus SFC on COPD exacerbations in more severe patients with a history of exacerbations is presented.

METHODS: This multicenter, double-blind, active-controlled study will randomize ~3332 patients with moderate-to-very severe COPD (1:1) to once-daily QVA149 (110μg indacaterol/50μg glycopyrronium) or twice-daily SFC (50/500μg) for 52 weeks. The study will have a 1-week screening, a 4-week run-in where tiotropium rather than rescue therapy alone will be provided to all patients, a 52-week blinded treatment, and a 30-day follow-up period. Patients ≥40 years, history of ≥1 COPD exacerbations in the past 12 months requiring systemic glucocorticosteroids and/or antibiotics and post-bronchodilator forced expiratory volume in 1 second ≥25 and <60% predicted value will be included.

RESULTS: Primary objective: to show that QVA149 is non-inferior to SFC for annual rate of all COPD exacerbations (mild/moderate/severe). Secondary outcomes: evaluating potential superiority of QVA149 versus SFC for annual rate of all exacerbations time to first COPD exacerbations, lung function, health status, safety and tolerability.

CONCLUSIONS: This study should provide the first evidence about the long-term effect of QVA149 on reduction of COPD exacerbations when compared with LABA/ICS in patients with a history of exacerbations. In addition, the data from the study should provide more evidence on additional benefits of LABA/long-acting muscarinic antagonist (LAMA) QVA149 over LABA/ICS in terms of improvements in lung function, health status, rescue medication use and safety in patients with COPD.

CLINICAL IMPLICATIONS: The results from this study should elucidate the potential place in therapy for dual bronchodilation with QVA149 versus LABA/ICS in a moderate-to-very severe COPD population with a history of exacerbations.

DISCLOSURE: Jadwiga Wedzicha: Consultant fee, speaker bureau, advisory committee, etc.: JW has received speaking fee and/or for advisory boards from GlaxoSmithKline, AstraZeneca, Novartis, Bayer, Boehringer Ingelheim, Nycomed. Chiesi and Respifor as well as travel reimbursements from Boehringer Ingelheim. JW has received research grants from GlaxoSmithKline, AstraZeneca, Chiesi and Novartis. Nicola Gallagher: Employee: Novartis employee Donald Banerji: Employee: Novartis employee The following authors have nothing to disclose: Jørgen Vestbo

Clinical trial results of QVA149, combination of two approved products indacaterol and glycopyrronium, will be presented, QVA is in the late stage phase 3 trials prior to approval




Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
PubMed Articles
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543