Who is sponsoring NCT04739774?

NCT04739774 is sponsored by Chiesi Farmaceutici S.p.A..

What drugs are being tested in NCT04739774?

Interventions in NCT04739774: CHF6001 DPI, Itraconazole.

What condition does NCT04739774 study?

NCT04739774 studies Chronic Obstructive Pulmonary Disease.

Is NCT04739774 still recruiting?

NCT04739774 is currently completed. Last updated 5 May 2021.

Last reviewed 2021-05-05 · How we verify

NCT04739774

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Investigation of the Effect of Inhibition of CYP3A4/5 by Itraconazole on the PK of CHF6001 (Tanimilast)

Completed Phase 1 Last updated 5 May 2021

What this trial tests

Phase 1 trial testing CHF6001 DPI in Chronic Obstructive Pulmonary Disease in 24 participants. Completed in 26 April 2021.

Timeline

22 February 2021

Primary endpoint
20 April 2021

26 April 2021

Quick facts

Lead sponsor	Chiesi Farmaceutici S.p.A.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	24
Start date	22 February 2021
Primary completion	20 April 2021
Estimated completion	26 April 2021
Sites	1 location across Belgium

Drugs / interventions tested

CHF6001 DPI — full drug profile →
Itraconazole — full drug profile →

Conditions studied

Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →

Sponsor

Chiesi Farmaceutici S.p.A. — full company profile →

Who can join

Adults 18 to 55, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this proposed study is to investigate the pharmacokinetics interaction between CHF6001 as substrate and Itraconazole as inhibitor of CYP3A4/5 in a drug-drug interaction study.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

An Overview of PDE4 Inhibitors in Clinical Trials: 2010 to Early 2022.
Crocetti L, Floresta G, Cilibrizzi A, Giovannoni MP. · · 2022 · cited 85× · PMID 35956914 · DOI 10.3390/molecules27154964
Clinical Implication of Phosphodiesterase-4-Inhibition.
Schick MA, Schlegel N. · · 2022 · cited 56× · PMID 35163131 · DOI 10.3390/ijms23031209

Verify or expand the search:

Other trials of CHF6001 DPI

Trials testing the same drug.

NCT06892756 — Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. · Phase 1 · completed
NCT06395610 — Effect of Erythromycin on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers · Phase 1 · completed

Other recruiting trials for Chronic Obstructive Pulmonary Disease

Currently open trials in the same condition.

NCT06749262 — Inclined Versus Standard Exercise for COPD Patients · NA · recruiting
NCT07406659 — Different Inspiratory Muscle Trainings in Patients With COPD · NA · recruiting
NCT07051707 — Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD · NA · recruiting
NCT07418736 — A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease · Phase 2 · recruiting
NCT07069829 — Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo · recruiting

Other Chiesi Farmaceutici S.p.A. trials

Trials by the same sponsor.

NCT07516951 — A Study to Find an Efficacious and Safe Dose of CHF10067 (Zampilimab) in Participants With Idiopathic Pulmonary Fibrosis · Phase 2 · not yet recruiting
NCT07301736 — Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma · Phase 2 · recruiting
NCT07163182 — Evaluation of Safety, Side Effects and How the Drug CHF6467 Administered Via Intranasal Route is Absorbed, Modified and · Phase 1 · recruiting
NCT06900816 — A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate C · Phase 2 · completed
NCT06892756 — Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04739774 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Chiesi Farmaceutici S.p.A.
Last refreshed: 5 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04739774.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing