July 29, 2015
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Olodaterol improves lung function in patients with asthma

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Olodaterol provided adequate 24-hour bronchodilation superior to placebo in patients with moderate to severe persistent asthma, according to study results.

No significant concerns with safety occurred and short-term safety and tolerability profiles of olodaterol mimicked those seen in other studies, the researchers reported.

“The results of this study add support to the growing evidence base that olodaterol delivered by Respimat (Boehringer Ingelheim) [once-daily] provides effective 24-hour bronchodilation in both COPD and asthma,” Kai-Michael Beeh, MD, founder of Insaf Respiratory Research Institute in Germany, and colleagues wrote.

Beeh and colleagues conducted a phase 2, multicenter, randomized, placebo-controlled, double blind study comparing the 24-hour forced expiratory volume in 1 second (FEV1) after 3 weeks’ treatment with once-daily or twice-daily olodaterol compared with placebo delivered using the Respimat inhaler in patients with moderate to severe asthma.

The analysis included 206 patients across 36 sites in six countries. Researchers administered either 5 µg of olodaterol once-daily or 2.5 µg of olodaterol twice-daily to patients and compared the results with placebo. The researchers increased the doses to 10 µg once-daily or 5 µg twice-daily and compared those results with placebo as well.

No matter what the dosage or frequency, all olodaterol treatments demonstrated significant improvements in FEV1 response at 3 weeks vs. placebo (P < .0001).

Each dose and frequency also improved mean morning and evening peak expiratory flow and total Asthma Control Questionnaire scores at 3 weeks compared with placebo (P < .0001 for all).

Thirty-five percent of patients reported at least one adverse event while on treatment.

Patients reported infections and infestations (14.1%) as the most frequent adverse event.

The data, however, should be interpreted with caution, according to the researchers.

“Further, long-term research would be required in order to fully examine the long-term safety and optimum dose regimen of olodaterol in patients with asthma,” the researchers wrote. – by Ryan McDonald

Disclosure: Beeh reports receiving funding from Almirall, Boehringer Ingelheim, GlaxoSmithKline, Infinity, Mundipharma, Novartis, Sterna AG and Teva Pharmaceuticals. Beeh also reports receiving consultancy and lecture fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cytos, Mundipharma, Novartis and Pfizer. Please see the full study for a list of all other authors’ relevant financial disclosures.