NEW YORK (Reuters Health) – Patients with moderate-to-severe chronic obstructive pulmonary disease have a greater improvement in dyspnea and health status after 12 weeks of treatment with inhaled indacaterol than with tiotropium, according to a report in the European Respiratory Journal online May 26.

Dr. Roland Buhl, with Mainz University Hospital in Germany, and colleagues note that the long-acting beta-2-agonist indacaterol is approved for use in many countries, including the EU.

To compare once-daily treatment with inhaled indacaterol or the inhaled anticholinergic tiotropium in COPD, the investigators recruited 1598 adult patients with a post-bronchodilator FEV1 <80% predicted and a smoking history of at least 10 pack years.

The patients were randomized to indacaterol 150 mcg/d or tiotropium 18 mcg/d via inhalation. For blinding purposes, patients receiving indacaterol also took placebo via the inhaler used for tiotropium, and vice versa.

The primary endpoint was the effect on trough FEV1 (i.e., at 24 hours post-dose), and it was seen to be similar with both treatments after 12 weeks. Trough FEV1 was 1.44 L with indacaterol and 1.43 L with tiotropium, and the mean changes from baseline were 130 mL (11.1%) and 120 mL (10.6%) with indacaterol and tiotropium, respectively.

Dyspnea was assessed by the transition dyspnea index (TDI) total score. At week 12, the reductions from baseline were significantly greater with indacaterol (2.01 points) than with tiotropium (1.43 points). A 1-point change or more is considered clinically relevant, the authors note, and patients taking indacaterol were significantly more likely than those taking tiotropium to achieve such an improvement (odds ratio 1.49; p<0.001).

Health status assessed by the St George’s Respiratory Questionnaire score after 12 weeks improved by 5.1 points with indacaterol compared to 3.0 with tiotropium, with 4 units or more considered a clinically relevant change.

Adverse events such COPD worsening, cough and nasopharyngitis were documents in 39.7% of patients in the indacaterol group and 37.2% in the tiotropium group, Dr. Buhl and colleagues report.

They conclude, “We believe that indacaterol may provide more symptomatic benefit than tiotropium and, as such, extends the therapeutic options for patients with COPD.”

Four of the seven authors of the report are employed by Novartis.

Eur Respir J 2011.