drugset / Trial / NCT02777827

A Single Dose PD & PK Study With Two Formulations of Abediterol in Patients With Asthma

NCT02777827

Phase 1 Completed 30 enrolled AstraZeneca
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to investigate the pharmacodynamics of single doses of abediterol given by 2 different devices in participants with asthma. Abediterol (AZD0548) is a potential for once daily treatment of asthma and chronic obstructive pulmonary disease (COPD) in fixed dose combination (FDC) with an inhaled corticosteroid (ICS) or a novel anti-inflammatory agent. The aim of the clinical studies is to enable further investigations in participants with asthma and COPD to evaluate and develop abediterol as an effective long acting bronchodilator with an acceptable safety profile compared to other inhaled bronchodilators on the market, for the treatment of asthma and COPD.

Timeline

Start
2016-06-21
Primary completion
2016-11-29
Completion
2016-11-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Abediterol Small molecule 0.05 ug Inhaled
Subject Abediterol Small molecule 0.156 ug Inhaled
Subject Abediterol Small molecule 2.5 ug Inhaled

Indications