Olodaterol for the treatment of asthma

ABSTRACT

Introduction: Long-acting β-agonist (LABA)/inhaled corticosteroid (ICS) combinations are still the mainstay of asthma therapy but there is a pressing need to increase adherence to the prescribed treatment achievable in general by reducing the dose frequency. Consequently, there is considerable interest within the pharmaceutical industry in the discovery of once-daily β2-agonists (ultra-LABAs) to be used as a part of a combination therapy for treating asthma.

Areas covered: The authors review the preclinical and clinical development of olodaterol, a new ultra-LABA characterized by an improved selectivity for β2-adrenoceptors and a rather high intrinsic efficacy profile, in asthma. The clinical results were generated by 4 Phase 2 trials, which have enrolled 731 asthmatic patients.

Expert opinion: The available results indicate that olodaterol is able to induce an effective 24-h bronchodilation and is safe. However, one cannot formulate a solid conclusion on the best dose and/or dose frequency to be used in asthma because trials were not powered to assess the differences between doses and dose frequencies. Apparently, there is no Phase 3 trial planned or ongoing for olodaterol monotherapy in patients with asthma and also no attempt to combine olodaterol with an ICS, which is surprising.

KEYWORDS:

• Asthma
• long-acting β-agonists
• olodaterol
• once-daily regimen

Declaration of interest

M Cazzola is a member of Boehringer Ingelheim speaker bureau. The Chair of Respiratory Medicine at the Department of Systems Medicine of the University of Rome Tor Vergata is receiving funding for research from Boehringer Ingelheim. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Box 1. Drug summary

Drug name: Olodaterol hydrochloride

Phase: II

Indication: Asthma

Pharmacology description/mechanism of action: Once-daily long-acting β₂-agonist designed with the aim of improving β₂-adrenoceptor selectivity and intrinsic activity

Route of administration: Oral inhalation, delivered by the Respimat inhaler

Chemical structure:

Pivotal trials: [35–37].