Treatment with Dual Bronchodilator Produces Significant Improvements in Lung Function in Patients with COPD

Article

Combination treatment with a fixed dose of indacaterol and glycopyrronium bromide was associated with significant improvements in several measures of lung function and health status compared to placebo and tiotropium in treatment-naïve patients with COPD.

Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines for the management of patients with moderate to very severe chronic obstructive pulmonary disease (COPD) recommend treatment with one or more long-acting bronchodilators. There are currently several treatment options available, making studies that compare the effects of one or more COPD drugs of potentially great value to patients and clinicians when making treatment decisions.

During a poster discussion session at the 2014 American Thoracic Society International Conference, Jadwiga A. Wedzicha, MD, Clinical Chair in Respiratory Medicine, National Heart & Lung Institute, Imperial College London, UK, presented results from a pooled analysis of four clinical trials that compared the effects of treatment with QVA149 to the effects of treatment with placebo and the long-acting anticholinergic tiotropium in treatment-naïve patients with COPD.

QVA149 is a dual bronchodilator combining the long-acting beta-2-agonist [LABA] indacaterol and the long-acting muscarinic antagonist [LAMA] glycopyrronium bromide in a fixed-dose combination (110 µg indacaterol and 50 µg glycopyrronium bromide) administered once daily.

Researchers looked at data from four randomized, parallel-group, multicenter trials that assessed the efficacy and safety of QVA149 in patients with COPD compared with the LAMA agent tiotropium (open label), or placebo. The SHINE (total of 2,224 subjects with moderate to severe COPD) and SPARK (2,144 subjects with severe to very severe COPD with one or more exacerbations in the past year) studies were the largest of the four studies and also included single-agent arms using indacaterol and/or glycopyrronium bromide. The duration of these trials varied between 26 weeks (SHINE) and 64 weeks (SPARK).

Overall, 886 treatment-naïve patients receiving QVA149 (n=276), indacaterol (n=103), glycopyrronium bromide (n=221), tiotropium (n=197), or placebo (n=89) were included in this pooled analysis of the four trials.

Researchers assessed changes in pre- and post-dose forced expiratory volume in one second (FEV1) at multiple intervals throughout the study. Three of the four studies also assessed changes using the St. George's Respiratory Questionnaire (SGRQ).

Compared to treatment with placebo and tiotropium, QVA149 was associated with significant improvements in pre-dose FEV1 at 3 and 6 months (p<0.001). Treatment with QVA149 was also associated with early significant improvements in post-dose FEV1 compared with placebo and open-label tiotropium (18 µg), an effect which was maintained over six months (p<0.001). These improvements were reflected in clinical improvements in lung function.

A statistically significant (p<0.05) improvement in SGRQ scores for QVA149-treated subjects compared to placebo- and tiotropium-treated patients was seen at 3 months but not at 6 months.

It should be noted that these 4 studies had variations in study design, with differences in treatment arms, study duration, number of patients enrolled, and the severity of COPD symptoms.

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