drugset / Trial / NCT02986321
A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the dose-response relationship of different doses of CHF6001 and to identify the optimal dose (s) in terms of benefit/risk ratio for further development in the target patient population.
Timeline
- Start
- 2016-12-15
- Primary completion
- 2017-10-04
- Completion
- 2018-01-09
Publications
- Govoni M, Bassi M, Santoro D, Donegan S, Singh D. Serum IL-8 as a Determinant of Response to Phosphodiesterase-4 Inhibition in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2023 Sep 1;208(5):559-569. doi: 10.1164/rccm.202301-0071OC.
- Singh D, Emirova A, Francisco C, Santoro D, Govoni M, Nandeuil MA. Efficacy and safety of CHF6001, a novel inhaled PDE4 inhibitor in COPD: the PIONEER study. Respir Res. 2020 Sep 22;21(1):246. doi: 10.1186/s12931-020-01512-y.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Budesonide | Small molecule | 800 ug | — |
| Subject | TRANIMILAST | Small molecule | 400 ug | Inhaled |
| Subject | TRANIMILAST | Small molecule | 800 ug | Inhaled |
| Subject | TRANIMILAST | Small molecule | 1200 ug | Inhaled |
| Subject | TRANIMILAST | Small molecule | 1600 ug | Inhaled |