New once-daily dual bronchodilator effective in COPD

Dec 18 2012

By Stephanie Leveene, medwireNews Reporter

A once-daily, inhaled, fixed-dose dual bronchodilator combination has greater efficacy than twice-daily salmeterol plus fluticasone (SFC) for the treatment of chronic obstructive pulmonary disease (COPD), results of the phase III ILLUMINATE trial show.

QVA149, a combination of the long-acting beta-2 agonist (LABA) indacaterol and the long-acting muscarinic antagonist (LAMA) glycopyrronium (NVA237), "provided significant, sustained, and clinically meaningful improvements in lung function versus twice-daily SFC, with significant symptomatic benefit," say lead author Claus Vogelmeier (Universitätsklinikum Gießen und Marburg, Germany) and colleagues.

Prior to these findings, published in The Lancet Respiratory Medicine, there were few comparative data on how LABA-LAMA combinations measured up to LABA-inhaled corticosteroid (ICS) therapy, and most trials have been short term.

However, some studies have shown that once-daily dosing is associated with greater overall adherence to COPD therapy. Hence, the once-daily dosing of QVA149 may simplify treatment.

Interpreting the current findings, Vogelmeier and colleagues say: "QVA149 once a day shows the potential of dual bronchodilation as a future treatment option for symptomatic patients with COPD, offering additional benefits over LABA-ICS combinations."

ILLUMINATE was a multicenter, randomized, double-blind, double-dummy study of 523 patients with moderate-to-severe COPD. Patients were given QVA149 110/50 µg or SFC 50/500 µg. Spirometry measurements were taken to assess forced expiratory volume in 1 second (FEV₁) and forced vital capacity (FVC) over 26 weeks of follow up.

Throughout the study, FEV₁ and FVC were significantly higher in the QVA149 group than in the SFC group. Bronchodilation with QVA149 was rapid, with meaningful results seen at 5 and 30 minutes postdose.

Transition dyspnea improved with QVA149 therapy. The incidence of adverse events was similar between treatment groups, with worsening of nasopharyngitis and COPD being the most common.

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 recommendations state that drug treatment for COPD should be determined by the level of the patient's airflow limitation, their symptoms, and exacerbation history. Long-acting bronchodilators such as LABAs and LAMAs are preferred therapy, either alone or in combination with an ICS, for maintenance treatment of patients with COPD. However, the guidelines recommend that ICSs only be given to high-risk patients with a history of frequent exacerbations.

The authors conclude that their findings "support the GOLD 2011 strategy recommendation of using one or more long-acting bronchodilators without an ICS in the management of symptomatic COPD patients at low risk for exacerbations."

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