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Tiotropium/Olodaterol Combo Shows Promise in COPD

Data presented at CHEST 2014 meeting

Positive data have been reported from the ANHELTO-1 and ANHELTO-2 studies, which evaluated the co-administration of Spiriva HandiHaler (tiotropium bromide inhalation powder) (T) plus Striverdi Respimat (olodaterol) inhalation spray (O) inhaler in patients with chronic obstructive pulmonary disease (COPD). Both products were developed by Boehringer Ingelheim.

The new findings were presented at the American College of Chest Physicians (ACCP) 80th annual meeting (CHEST 2014), held in Austin, Texas, and were published online in the International Journal of Chronic Obstructive Pulmonary Disease.

At week 12, patients receiving T + O showed significant improvements in lung function, as measured by trough forced expiratory volume in 1 second (FEV1) and FEV1 area under the curve from 0 to 3 hours (FEV1 AUC0-3h), compared with patients receiving tiotropium plus placebo (T + P).

Spiriva HandiHaler is a once-daily long-acting muscarinic antagonist (LAMA) indicated for both the maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema, and to reduce COPD exacerbations.

Striverdi Respimat is a once-daily long-acting beta agonist (LABA) indicated for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Striverdi Respimat is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma. Spiriva HandiHaler delivers the medication as a powder, and Striverdi Respimat delivers olodaterol as a slow-moving mist.

The ANHELTO-1 and ANHELTO-2 trials were 12-week, replicate, double-blind studies in which COPD patients were randomly assigned to receive either tiotropium 18 mcg once daily (via HandiHaler) plus olodaterol 5 mcg once daily (via Respimat) or tiotropium 18 mcg once daily (via HandiHaler) plus placebo (via Respimat). The two studies included more than 2,200 patients with COPD. The primary efficacy endpoints were the change from baseline in trough FEV1 and FEV1 AUC0-3 after 12 weeks.

In the ANHELTO-1 trial, the mean difference between the T + O and T + P groups for FEV1 AUC0-3 was 117 mL (P < 0.0001), and the mean difference between the two groups for trough FEV1 was 62 mL (P < 0.0001). In the ANHELTO-2 trial, the corresponding values were 106 mL (P < 0.0001) and 40 mL (P < 0.0029).

The percentage of patients experiencing an adverse event (AE) in ANHELTO-1 was 45.3% with T + O 18/5 mcg and 42.8% with tiotropium 18 mcg. In ANHELTO-2, 40.1% of patients in the T + O 18/5-mcg group experienced an AE compared with 43.2% of the tiotropium 18-mcg group. The most frequent adverse events across the two studies were worsening of COPD (10.7%) and dry mouth (2.7%).

Source: Boehringer Ingelheim; October 27, 2014.

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