Who is sponsoring NCT02386761?

NCT02386761 is sponsored by Chiesi Farmaceutici S.p.A..

What drugs are being tested in NCT02386761?

Interventions in NCT02386761: Single Ascending Dose (SAD), Multiple Ascending Dose (MAD).

What condition does NCT02386761 study?

NCT02386761 studies Chronic Obstructive Pulmonary Disease.

Is NCT02386761 still recruiting?

NCT02386761 is currently completed. Last updated 30 July 2020.

Last reviewed 2020-07-30 · How we verify

NCT02386761: CHF6001Ext

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

A Phase 1, Randomised Double-blind, Placebo-controlled STUDY of Single and Repeated Ascending doseS in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6001

Completed Phase 1 Last updated 30 July 2020

What this trial tests

Phase 1 trial testing Single Ascending Dose (SAD) in Chronic Obstructive Pulmonary Disease in 48 participants. Completed in 1 May 2015.

Timeline

1 November 2014

Primary endpoint
1 May 2015

1 May 2015

Quick facts

Lead sponsor	Chiesi Farmaceutici S.p.A.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	48
Start date	1 November 2014
Primary completion	1 May 2015
Estimated completion	1 May 2015
Sites	1 location across United Kingdom

Drugs / interventions tested

Single Ascending Dose (SAD) — full drug profile →
Multiple Ascending Dose (MAD) — 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. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 0-14 days

Sponsor's own description

A phase I randomised, double-blind, placebo-controlled study of single and repeated ascending doses in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of inhaled chf 6001.

Publications & conference data

6 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
Mechanisms, Pathophysiology and Currently Proposed Treatments of Chronic Obstructive Pulmonary Disease.
Rodrigues SO, Cunha CMCD, Soares GMV, Silva PL, et al · · 2021 · cited 61× · PMID 34681202 · DOI 10.3390/ph14100979
Clinical Implication of Phosphodiesterase-4-Inhibition.
Schick MA, Schlegel N. · · 2022 · cited 56× · PMID 35163131 · DOI 10.3390/ijms23031209
p38 MAPK signaling in chronic obstructive pulmonary disease pathogenesis and inhibitor therapeutics.
Ahmadi A, Ahrari S, Salimian J, Salehi Z, et al · · 2023 · cited 25× · PMID 37919729 · DOI 10.1186/s12964-023-01337-4
Safety, tolerability, and pharmacokinetics of single and repeat ascending doses of CHF6001, a novel inhaled phosphodiesterase-4 inhibitor: two randomized trials in healthy volunteers.
Mariotti F, Govoni M, Lucci G, Santoro D, et al · · 2018 · cited 22× · PMID 30425469 · DOI 10.2147/copd.s174156
The COPD Pipeline XXX.
Gross N. · · 2015 · cited 1× · PMID 28848873 · DOI 10.15326/jcopdf.3.1.2015.0181

Verify or expand the search:

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 NCT02386761 (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: 30 July 2020

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/NCT02386761.

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