A Single Dose PD & PK Study With Two Formulations of Abediterol in Patients With Asthma
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
Outcome
Met primary endpoint
registry analysis (superiority test); Abediterol Dry Powder Inhaler 0.156 μg vs Placebo; p <0.0001; Least square mean 0.2221 (95% CI 0.1324 to 0.3118); ANCOVA NCT02777827 ↗
registry analysis (superiority test); Abediterol Pressurised Metered-dose Inhaler 2.5μg vs Placebo; p <0.0001; Least Square Mean 0.4062 (95% CI 0.3170 to 0.4955); ANCOVA NCT02777827 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abediterol | Small molecule | 0.05 ug | Inhaled |
| Subject | Abediterol | Small molecule | 0.156 ug | Inhaled |
| Subject | Abediterol | Small molecule | 2.5 ug | Inhaled |