drugset / Trial / NCT03004417
Pharmacodynamics, Pharmacokinetics and Safety of Two Doses of CHF6001 DPI in Subjects With Moderate, Severe COPD
RandomizedCrossoverQuadruple-blindTreatment
Summary
Effect of CHF 6001 on biomarkers of inflammation in induced sputum and in blood, on pulmonary function and on symptoms benefits in comparison with placebo.
Timeline
- Start
- 2016-10-31
- Primary completion
- 2017-12-28
- Completion
- 2017-12-28
Publications
- Background Govoni M, Bassi M, Vezzoli S, Lucci G, Emirova A, Nandeuil MA, Petruzzelli S, Jellema GL, Afolabi EK, Colgan B, Leaker B, Kornmann O, Beeh KM, Watz H, Singh D. Sputum and blood transcriptomics characterisation of the inhaled PDE4 inhibitor CHF6001 on top of triple therapy in patients with chronic bronchitis. Respir Res. 2020 Mar 20;21(1):72. doi: 10.1186/s12931-020-1329-y.
- Results Singh D, Beeh KM, Colgan B, Kornmann O, Leaker B, Watz H, Lucci G, Geraci S, Emirova A, Govoni M, Nandeuil MA. Effect of the inhaled PDE4 inhibitor CHF6001 on biomarkers of inflammation in COPD. Respir Res. 2019 Aug 9;20(1):180. doi: 10.1186/s12931-019-1142-7.
- 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, Watz H, Beeh KM, Kornmann O, Leaker B, Colgan B, Lucci G, Emirova A, Nandeuil MA, Santoro D, Balzano D, Govoni M. COPD sputum eosinophils: relationship to blood eosinophils and the effect of inhaled PDE4 inhibition. Eur Respir J. 2020 Aug 6;56(2):2000237. doi: 10.1183/13993003.00237-2020. Print 2020 Aug.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TRANIMILAST | Small molecule | 800 ug | Inhaled |
| Subject | TRANIMILAST | Small molecule | 1600 ug | Inhaled |