NCT03859414 is a Phase 1 clinical trial of Therapeutic Dose 1 in Asthma, sponsored by Chiesi Farmaceutici S.p.A..

Who is sponsoring NCT03859414?

NCT03859414 is sponsored by Chiesi Farmaceutici S.p.A..

What drugs are being tested in NCT03859414?

Interventions in NCT03859414: Therapeutic Dose 1, Therapeutic Dose 2, Supra-therapeutic Dose, Placebo.

What condition does NCT03859414 study?

NCT03859414 studies Asthma, Chronic Obstructive Pulmonary Disease.

Is NCT03859414 still recruiting?

NCT03859414 is currently completed. Last updated 22 October 2021.

Last reviewed 2021-10-22 · How we verify

NCT03859414

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

PK of BDP/FF/GB Single-inhaler Triple Therapy in Japanese vs. Caucasians

Completed Phase 1 Last updated 22 October 2021

What this trial tests

Phase 1 trial testing Therapeutic Dose 1 in Asthma in 32 participants. Completed in 24 July 2019.

Timeline

18 March 2019

Primary endpoint
24 July 2019

24 July 2019

Quick facts

Lead sponsor	Chiesi Farmaceutici S.p.A.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	other
Enrollment	32
Start date	18 March 2019
Primary completion	24 July 2019
Estimated completion	24 July 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

Therapeutic Dose 1 — full drug profile →
Therapeutic Dose 2
Supra-therapeutic Dose — full drug profile →
Placebo

Conditions studied

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

Sponsor

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

Who can join

Adults 20 to 55, any sex, with Asthma or Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of conducting this study is to obtain PK data of Beclometasone Dipropionate (BDP)/Beclometasone-17-MonoPropionate (B17MP), Formoterol Fumarate (FF) and Glycopyrronium Bromide (GB) after inhalation of CHF 5993 in Japanese as well as Caucasian healthy subjects under the same setting.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Ethnic Sensitivity Study of the Extrafine, Single-Inhaler, Triple Therapy Beclomethasone Dipropionate, Formoterol Fumarate, and Glycopyrronium Bromide Pressurized Metered Dose Inhaler in Japanese and Caucasian Healthy Individuals: A Randomized, Double-Blind, Single-Dose Crossover
Cella M, Täubel J, Delestre-Levai I, Tulard A, et al · · 2021 · cited 6× · PMID 34600734 · DOI 10.1016/j.clinthera.2021.09.001

Verify or expand the search:

Other recruiting trials for Asthma

Currently open trials in the same condition.

NCT07525375 — A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared t · Phase 2 · recruiting
NCT07536256 — Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being · NA · recruiting
NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · 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 NCT03859414 (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: 22 October 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/NCT03859414.

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