Abediterol is a novel, once-daily, fine-particle therapy being developed by AstraZeneca for the treatment of chronic obstructive pulmonary disease (COPD). The investigational drug is a long-acting beta2-agonist (LABA) that has a bronchodilator effect, relaxing the muscles around the airways.

The treatment, now being tested in Phase 2 clinical trials, is a dry powder inhaler (DPI) which consists of a device that delivers the drug directly to the lungs as a very fine powder.

Abediterol and clinical trials

Preclinical studies of abediterol on animals revealed a safe cardiovascular profile to be used in a once-daily dose in humans. The first Phase 1 study on 48 healthy men ages 18 to 45 evaluated abediterol’s safety, tolerability, pharmacokinetics and pharmacodynamics. The participants were given abediterol in doses of 5, 10, 25 or 50 micrograms or a placebo. The safety and tolerability of the drug was demonstrated, suggesting a potent bronchodilator effect.

The first Phase 2 study (NCT01425814) of abediterol as a COPD treatment was completed in 2012. It evaluate four single doses of inhaled abediterol at 0.625, 2.5, 5 or 10 micrograms and compared its bronchodilation, safety and tolerability to a plecebo and an active comparator (indacaterol, 150 micrograms). Results showed that all doses significantly improved bronchodilation when compared to a placebo. Doses of 2.5, 5, and 10 micrograms also showed improvements when compared to the active comparator.

A Phase 1 study is ongoing (NCT02967159), evaluating the pharmacokinetics and safety of single inhaled doses of abediterol and AstraZeneca’s investigational drug AZD7594, a once-daily nonsteroidal and selective modulator of the glucocorticoid receptor.

Abediterol and AZD7594 are being administered alone, in fixed dose combination (abediterol/AZD7594), and in free combination (abediterol and AZD7594). Men ages 18 to 55 are enrolled in the study, which is expected to be completed in April 2017.

Other details

During the first Phase 1 study, the most frequent adverse events were palpitations, tremor, nausea and asthenia (loss of energy). Most of them were mild in intensity.

It was also studied for the treatment of asthma (NCT01425801 and NCT02777827). Results from the NCT01425801 clinical trial showed that the drug was well tolerated in people with asthma and that doses of 0.625, 1.25 and 2.5 micrograms result in a significant bronchodilation effect. The NCT02777827 trial was completed in November 2016 and results are not yet available.

 

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