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Positive Results Reported for Tiotropium/Olodaterol Combo in Patients With COPD

Phase III data show improved lung function

Positive results have been reported from a phase III trial evaluating the effect of a fixed-dose combination of tiotropium and olodaterol (T+O FDC, Boehringer Ingelheim) delivered via the Respimat inhaler on lung function in patients with chronic obstructive pulmonary disease (COPD).

The new data were presented at the American Thoracic Society 2014 International Conference, held May 16–21 in San Diego, California.

Once-daily T+O FDC is an investigational treatment that combines the long-acting muscarinic antagonist (LAMA) tiotropium with olodaterol, an investigational long-acting beta agonist (LABA), delivered via the propellant-free Respimat inhaler. The phase III clinical trial program for T+O FDC includes more than 8,000 patients with COPD.

In the VIVACITO trial, 219 patients with moderate to very severe COPD were randomly assigned to receive four of the following treatments for 6 weeks, each with a 3-week period of no treatment in between: 1) placebo; 2) olodaterol 5 mcg; 3) tiotropium 2.5 mcg or tiotropium 5 mcg; or 4) T+O FDC 2.5/5 mcg or T+O FDC 5/5 mcg. The trial’s primary endpoint was the forced expiratory volume in 1 second (FEV1) over 24 hours after 6 weeks of treatment. Secondary endpoints included additional tests measuring breathing over 24 hours.

The 24-hour time profiles for both T+O FDCs were similar and showed improvements in lung function, as measured by FEV1, compared with placebo and monotherapies over 24 hours. Both FDCs were significantly superior to placebo (P < 0.001).

In addition, trough FEV1 was measured as a secondary endpoint. Results showed increases in lung function at the end of the 24-hour dosing interval for the two T+O FDCs compared with placebo and monotherapies. Trough FEV1 responses were 0.201 L for T+O 5/5 mcg and 0.196 L for T&O 2.5/5 mcg, compared with 0.122 L for tiotropium 5 mcg, 0.095 L for tiotropium 2.5 mcg, 0.109 L for olodaterol 5 mcg, and –0.006 L for placebo.

The overall incidence of adverse events (AEs) was comparable among treatment groups: 36.0% for T+O FDC 2.5/5 mcg; 37.4% for T+O FDC 5/5 mcg; 37.7% for olodaterol 5 mcg; 39.4% for tiotropium 2.5 mcg; 44.2% for tiotropium 5 mcg; and 46.4% for placebo. The most common AEs were nasopharyngitis and worsening of COPD.

Source: Boehringer Ingelheim; May 21, 2014.

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