drugset / Trial / NCT02573155
Two-part Safety, Tolerability, Pharmacodynamic and -Kinetic Study of Inhaled AZD8871 in Asthmatic and COPD Subjects
RandomizedCrossoverSingle-blindTreatment
Summary
This is a phase I, randomised, placebo-controlled 2-part study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8871 delivered by inhalation, in asthmatic and chronic obstructive pulmonary disease (COPD) subjects.
Timeline
- Start
- 2015-10
- Primary completion
- 2016-08
- Completion
- 2016-08
Publications
- Jimenez E, Astbury C, Albayaty M, Wahlby-Hamren U, Seoane B, Villarroel C, Pujol H, Bermejo MJ, Aggarwal A, Psallidas I. Navafenterol (AZD8871) in patients with mild asthma: a randomised placebo-controlled phase I study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of this novel inhaled long-acting dual-pharmacology bronchodilator. Respir Res. 2020 Sep 9;21(Suppl 1):211. doi: 10.1186/s12931-020-01470-5.
- Singh D, Balaguer V, Astbury C, Wahlby-Hamren U, Jimenez E, Seoane B, Villarroel C, Lei A, Aggarwal A, Psallidas I. Navafenterol (AZD8871) in patients with COPD: a randomized, double-blind, phase I study evaluating safety and pharmacodynamics of single doses of this novel, inhaled, long-acting, dual-pharmacology bronchodilator. Respir Res. 2020 Sep 9;21(Suppl 1):102. doi: 10.1186/s12931-020-01347-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indacaterol | Other / unclassified | 150 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 18 ug | Inhaled |
| Subject | navafenterol | Small molecule | 50 ug | Inhaled |
| Subject | navafenterol | Small molecule | 100 ug | Inhaled |
| Subject | navafenterol | Small molecule | 300 ug | Inhaled |
| Subject | navafenterol | Small molecule | 400 ug | Inhaled |
| Subject | navafenterol | Small molecule | 600 ug | Inhaled |
| Subject | navafenterol | Small molecule | 1200 ug | Inhaled |
| Subject | navafenterol | Small molecule | 1800 ug | Inhaled |