In the Field

Olodaterol improves FEV1 in patients with asthma

Olodaterol improved forced expiratory volume in 1 second as well as peak expiratory flow in patients with asthma, according to study results.

Olodaterol also appeared to improve asthma-related symptoms as measured by a reduction in asthma control questionnaire scores.

Paul M. O’Byrne, MB, FRCPI, chair of the department of medicine at McMaster University Medical Center in Canada, and colleagues conducted two multi-center studies to assess the safety and efficacy of 4 weeks’ once-daily olodaterol (Striverdi Respimat, Boehringer Ingelheim) treatment — at various doses — in patients with asthma.

The first study included a randomized, double-blind, parallel-group study of 296 patients administered treatment in the morning. Participants received 2, 5, 10 and 20 µg of olodaterol in the first group. Researchers then conducted pulmonary function tests to assess forced expiratory volume in 1 second (FEV1).

The second study included a randomized, double blind, placebo- and active-controlled (formoterol 12 µg twice daily) incomplete-block crossover study. The analysis included 198 patients who received in the evening the same doses as the first group for a 16-week treatment period comprised of four 4 week treatments.

Olodaterol 20 µg significantly improved trough FEV1 (0.147 L; P = .001) compared with placebo in patients from the first study. The other doses demonstrated limited efficacy and no evidence of dose response compared with placebo.

The second study demonstrated that all active treatments increased FEV1 responses 4 weeks after treatment (P < .0001).

Patients who received 2 µg (n = 61; 37.7%), 5 µg (n = 60; 40%), 10 µg (n = 60; 30%) and 20 µg (n = 61; 27.8%) of olodaterol in the first study reported some incidence of an adverse event. However, only 24 appeared drug related.

Adverse events occurred less often in patients from the second study. Patients who received 2 µg (9.9%), 5 µg (13.8%), 10 µg (15.7%), and 20 µg of olodaterol (12.9 %), as well as 12 µg formoterol (6.4%) reported adverse events. In the second study, only eight of the adverse events appeared drug related.

“Treatment with olodaterol [once daily] for 4 weeks was well tolerated at all doses and no new safety concerns were identified, although some sympathomimetic effects were observed, mainly at the 20 µg dose,” the researchers wrote. “Parallel, as well as incomplete-block crossover, designs may be suitable for phase 2 dose-ranging studies and more than one study may be necessary to strengthen the evidence for a dose response.” – by Ryan McDonald

The drug’s effect on patients lasted for more than 24 hours, according to the researchers.

Disclosure: O’Byrne reports receiving research funding from Amgen, AstraZeneca, Genentech and Novartis. O’Byrne also reports receiving consultancy fees from AstraZeneca and Chiesi. Please see the full study for a list of O’Byrne’s and all other researchers’ relevant financial disclosures.

Olodaterol improved forced expiratory volume in 1 second as well as peak expiratory flow in patients with asthma, according to study results.

Olodaterol also appeared to improve asthma-related symptoms as measured by a reduction in asthma control questionnaire scores.

Paul M. O’Byrne, MB, FRCPI, chair of the department of medicine at McMaster University Medical Center in Canada, and colleagues conducted two multi-center studies to assess the safety and efficacy of 4 weeks’ once-daily olodaterol (Striverdi Respimat, Boehringer Ingelheim) treatment — at various doses — in patients with asthma.

The first study included a randomized, double-blind, parallel-group study of 296 patients administered treatment in the morning. Participants received 2, 5, 10 and 20 µg of olodaterol in the first group. Researchers then conducted pulmonary function tests to assess forced expiratory volume in 1 second (FEV1).

The second study included a randomized, double blind, placebo- and active-controlled (formoterol 12 µg twice daily) incomplete-block crossover study. The analysis included 198 patients who received in the evening the same doses as the first group for a 16-week treatment period comprised of four 4 week treatments.

Olodaterol 20 µg significantly improved trough FEV1 (0.147 L; P = .001) compared with placebo in patients from the first study. The other doses demonstrated limited efficacy and no evidence of dose response compared with placebo.

The second study demonstrated that all active treatments increased FEV1 responses 4 weeks after treatment (P < .0001).

Patients who received 2 µg (n = 61; 37.7%), 5 µg (n = 60; 40%), 10 µg (n = 60; 30%) and 20 µg (n = 61; 27.8%) of olodaterol in the first study reported some incidence of an adverse event. However, only 24 appeared drug related.

Adverse events occurred less often in patients from the second study. Patients who received 2 µg (9.9%), 5 µg (13.8%), 10 µg (15.7%), and 20 µg of olodaterol (12.9 %), as well as 12 µg formoterol (6.4%) reported adverse events. In the second study, only eight of the adverse events appeared drug related.

“Treatment with olodaterol [once daily] for 4 weeks was well tolerated at all doses and no new safety concerns were identified, although some sympathomimetic effects were observed, mainly at the 20 µg dose,” the researchers wrote. “Parallel, as well as incomplete-block crossover, designs may be suitable for phase 2 dose-ranging studies and more than one study may be necessary to strengthen the evidence for a dose response.” – by Ryan McDonald

The drug’s effect on patients lasted for more than 24 hours, according to the researchers.

Disclosure: O’Byrne reports receiving research funding from Amgen, AstraZeneca, Genentech and Novartis. O’Byrne also reports receiving consultancy fees from AstraZeneca and Chiesi. Please see the full study for a list of O’Byrne’s and all other researchers’ relevant financial disclosures.