Clinical trials: sponsored by Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease (COPD)
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.
The study is performed to characterize the pharmacokinetics of glycopyrrolate bromide after single administration of CHF 5993 pressurised Metered Dose Inhaler (pMDI) in subjects with different level of renal impairment in…
- Trial name
- TRIPLE10 (NCT02040597)
- Testing
- Beclometasone/Formoterol/Glycopyrrolate
- Where
- 2 sites in Poland
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
COPD
Drug-drug Interaction Study of CHF5993 With Cimetidine
The purpose of this study is to evaluate the pharmacokinetic interaction when CHF5993 (pressurized metered-dose inhaler (pMDI) is administered with Cimetidine (probe inhibitor of the organic cation transport in the kidneys), by…
- Trial name
- NCT02287272
- Testing
- CHF 5993 pMDI, Cimetidine plus CHF5993 pMDI
- Where
- Belgium
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma, Chronic Obstructive Pulmonary Disease
PK of BDP/FF/GB Single-inhaler Triple Therapy in Japanese vs. Caucasians
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…
- Trial name
- NCT03859414
- Testing
- Therapeutic Dose 1, Therapeutic Dose 2, Supra-therapeutic Dose
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of CHF 5993 pMDI Combination in Healthy Volunteers
The study is performed to evaluate the total systemic exposure and lung bioavailability of CHF 5993 pMDI combination, in healthy volunteers subjects.
- Trial name
- NCT02359292
- Testing
- CHF 5993 HS 200/6/25 pMDI, CHF 5993 MS 100/6/25 pMDI, CHF 5993 HS 200/6/25 pMDI + Charcoal Block
- Where
- Belgium
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
COPD
Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and the Lung Availability of CHF 5993 in Healthy Volunteers
This clinical pharmacology study is performed to evaluate the total systemic exposure and the lung availability of CHF 5993 DPI and pMDI with and without valved holding chamber, in healthy volunteers.
- Trial name
- NCT02743013
- Testing
- CHF 5993 100/6/12,5 pMDI, CHF 5993 100/6/12,5 DPI Test 1, CHF 5993 100/6/12,5 DPI Test 2
- Where
- Belgium
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
Investigation of the Effect of Inhibition of CYP3A4/5 by Itraconazole on the PK of CHF6001 (Tanimilast)
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.
- Trial name
- NCT04739774
- Testing
- CHF6001 DPI, Itraconazole
- Where
- Belgium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Healthy Volunteers
Foster With or Without Charcoal Block or Aerochamber Plus
The purpose of this study is to evaluate the systemic exposure of BDP, its metabolite beclomethasone 17-monopropionate (B17MP) and formoterol after inhalation of BDP/Formoterol 100/6 µg pMDI combination (CHF1535) using the…
- Trial name
- NCT01280175
- Testing
- charcoal block, Aerochamber Plus spacer, pMDI standard actuator
- Where
- Switzerland
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease (COPD)
Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers (HV)
This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF 6001 after single and multiple doses in healthy volunteers.
- Trial name
- NCT01703052
- Where
- United Kingdom
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001
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.
- Trial name
- CHF6001Ext (NCT02386761)
- Testing
- Single Ascending Dose (SAD), Multiple Ascending Dose (MAD)
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
PK Linearity and Steady State PK of CHF 6532 in Healthy Subjects
The purpose of this clinical pharmacology study is to evaluate the CHF 6532 linearity after single oral administrations of four doses of a tablet formulation and to evaluate the pharmacokinetic (PK) at steady state following the…
- Trial name
- NCT03942666
- Testing
- Treatment A, Treatment B, Treatment C
- Where
- Belgium
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma, Chronic Obstructive Pulmonary Disease
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose in Healthy Volunteers, Repeat Doses in Asthmatic Patients and of Single Dose in COPD Patients of CHF6366
CHF6366 is a novel bifunctional compound displaying both muscarinic receptor antagonist and β2-adrenergic receptor agonist properties (MABA), with the potential to deliver optimal bronchodilation after inhalation dosing via two…
- Trial name
- NCT03378648
- Testing
- CHF6366, umeclidinium bromide and vilanterol trifenatate
- Where
- United Kingdom
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of CHF6297 in Healthy Subjects and Patients With COPD
CHF6297 is a potent and selective inhibitor of human MAP kinase p38 being developed as an anti-inflammatory agent for the treatment of inflammatory airways diseases.
- Trial name
- CHF6297 FIH (NCT02815488)
- Testing
- CHF6297 (Part 1 - SAD), CHF6297 (Part 2 - MAD), CHF6297 (Part 3)
- Where
- 2 sites in United Kingdom
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Non-Cystic Fibrosis Bronchiectasis, Cystic Fibrosis
A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects
Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic lung inflammation that characterized many diseases.
- Trial name
- CHF6333 FIH (NCT03056326)
- Testing
- CHF6333 (Part 1 - SAD), CHF6333 (Part 2 - MAD)
- Where
- Belgium
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease, Asthma
Lung Deposition of Beclometasone Dipropionate/Formoterol Fumarate/Glycopyrronium Bromide Administered Via pMDI in Healthy, Asthmatic and COPD Patients
The purpose of this study is to investigate the lung deposition and distribution pattern of Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide using a Gamma-scintigraphic technique after inhalation of a single…
- Trial name
- NCT02975843
- Testing
- Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Copd
Pharmacokinetic Interaction and the Safety of Inhaled CHF5259 and CHF6001
To evaluate systemic pharmacokinetics of CHF6001 following concomitant administration of CHF6001 and CHF5259, in comparison with the single components, administered in healthy subjects via a multi-dose reservoir NEXThaler® DPI.
- Trial name
- NCT03004495
- Testing
- CHF5259 and CHF6001
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
COPD
Study to Investigate the Pharmacokinetics of CHF 6001 DPI Administered Via Nexthaler® Device or the Capsule for Oral Inhalation Via Aerolizer® Device
The purpose of this study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 administered using the multi-dose NEXThaler® device or the single-dose capsule inhaler Aerolizer®.
- Trial name
- NCT02119247
- Testing
- CHF 6001 dry powder for inhalation via NEXThaler®, CHF 6001 DPI capsules for inhalation via Aerolizer
- Where
- Belgium
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
Evaluation of Possible Effects on the QTc Interval of CHF 4226 pMDI in Healthy Volunteers
The purpose of this study is to evaluate the effect of single doses of therapeutic and supratherapeutic doses of inhaled CHF 4226 pMDI on ventricular repolarization in healthy subjects compared with placebo.
- Trial name
- CT14 (NCT00777595)
- Testing
- CHF 4226 pMDI, Moxifloxacin
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.