Clinical trials: sponsored by Chiesi Farmaceutici S.p.A.
Pulmonary Fibrosis
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF10073 After Single and Multiple Doses in Healthy Volunteers and the Effect of Itraconazole on CHF10073 Exposure
The objective of this study is to assess the safety and tolerability of single ascending doses of inhaled CHF10073 (Part 1 of the study) and multiple ascending doses of CHF10073 (Part 2 of the study).
- Trial name
- NCT06746064
- Testing
- CHF10073 (Part 1 - SAD), CHF10073 (Part 2 - MAD), CHF10073 (Part 3)
- Where
- Belgium
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)
The purpose of this study is to evaluate the efficacy and the safety of two doses of CHF6001 (Tanimilast) as add-on to maintenance triple therapy in the target patient population.
- Trial name
- PILLAR (NCT04636814)
- Testing
- CHF6001 1600µg, CHF6001 3200µg, Roflumilast
- Where
- 460 sites in United States, Argentina and 26 more
- Volunteers
- 3,973 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa
The goal of this clinical trial is to learn if Oleogel-S10 gel works to treat skin wounds from two types of inherited epidermolysis bullosa (EB): junctional EB (JEB) or dystrophic EB (DEB) in the Japanese population.
- Conditions
- Epidermolysis Bullosa, Junctional Epidermolysis Bullosa, Epidermolysis Bullosa, Dystrophic, Epidermolysis Bullosa, Junctional
- Trial name
- REVIVE (NCT06917690)
- Testing
- Oleogel-S10
- Where
- 6 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Uncontrolled Asthma
Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy
The purpose of this study is to evaluate the efficacy and safety of CHF6001 (Tanimilast) as add-on to maintenance of inhaled corticosteroids in combination with Long-acting ß2-agonists in the target patient population. (TANGO)
- Trial name
- TANGO (NCT06029595)
- Testing
- Experimental: CHF6001 3200 μg
- Where
- 187 sites in Argentina, Bulgaria and 12 more
- Volunteers
- 517 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)
The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.
- Trial name
- PILASTER (NCT04636801)
- Testing
- Experimental: CHF6001 1600µg, Experimental: CHF6001 3200µg
- Where
- 447 sites in United States, Albania and 28 more
- Volunteers
- 4,710 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
Real-World Effectiveness of a Triple Combination BDP/FF/GB in a Single Pressurised Metered Dose Inhaler in COPD Patients (TRIPHY)
The purpose of the study is to evaluate Real-World Effectiveness of a Triple Combination Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (BDP/FF/GB) in a Single Pressurised Metered Dose Inhaler (Trimbow®…
- Trial name
- TRIPHY (NCT06480890)
- Where
- 19 sites in China
- Volunteers
- 362 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate CHF 6001
The purpose of this study is to evaluate the amount of the study drug, CHF6001, in the blood of adolescent patients with asthma in comparison to adult patients with asthma after a single oral dose of the study drug, CHF 6001.
- Trial name
- NCT06900816
- Testing
- CHF 6001
- Where
- Bulgaria
- Volunteers
- 50 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease
A Multi-Country Observational Study of Safety and Effectiveness of Elfabrio® in Fabry Patients
A multi-centre, multi-country, observational, non-interventional, retrospective and prospective (hybrid) study among Fabry disease participants treated with pegunigalsidase alfa (Elfabrio®) in routine clinical care.
- Trial name
- MODERN (NCT06663358)
- Testing
- Pegunigalsidase-alfa
- Where
- 10 sites in United States, Slovenia and 1 more
- Volunteers
- 100 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease (COPD)
Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study
The main goal of this pharmacokinetic study in healthy volunteers is to evaluate the potential effect of cyclosporine (probe inhibitor of P glycoprotein [P-gp] and breast cancer resistance protein [BCRP] transporters) on CHF6001…
- Trial name
- DDI2 (NCT06892756)
- Testing
- CHF6001 dry powder inhaler (DPI), Cyclosporine, CHF6001 DPI
- Where
- Bulgaria
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Idiopathic Pulmonary Fibrosis
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF (SAD).
Assess the safety of CHF10067 (study drug) and any side effects that might be associated with it. The study also evaluated how much of the study drug gets into the bloodstream and how long the body takes to remove it.
- Trial name
- NCT05513950
- Testing
- CHF10067 starting dose -- 1000mg (Cohort A), CHF10067 intermediate dose -- 2000mg (Cohort B), CHF10067 high dose -- 3000mg (Cohort C)
- Where
- 9 sites in North Macedonia, Ukraine and 1 more
- Volunteers
- 52 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Alpha-Mannosidosis
Analysis of Velmanase Alfa (Lamzede®)'s Effects in the Body of Children With Alpha-Mannosidosis Under the Age 3
The goal of this observational study is to learn the effects of the drug velmanase alfa (Lamzede®) in the bodies of children under the age of 3 with Alpha-Mannosidosis.
- Trial name
- LAMPO(0-3) (NCT06184503)
- Testing
- Velmanase Alfa
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Pediatric Perioperative Blood Pressure Management
Assessment of Efficacy, Safety and Dosing of Clevidipine in Pediatric Participants Undergoing Surgery (PIONEER)
Evaluate the efficacy, safety, and dosing of clevidipine as an intravenous (IV) infusion for blood pressure (BP) management in paediatric participants in the perioperative setting.
- Trial name
- PIONEER (NCT01938547)
- Testing
- clevidipine
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Prospective Study on Asthma Control
Accordingly, the new update of the Global Initiative for Asthma (GINA) guidelines 2006 is based on the control of the disease and attempts to quantify and graduate the level of control by using a classification of asthmatic…
- Trial name
- PRISMA (NCT01110460)
- Volunteers
- 2,875 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
COPD
Investigate the Safety, Tolerability and Pharmacokinetics of CHF6523 in Healthy and in COPD Subjects
This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF6523 DPI in healthy male subjects first and then in COPD subjects after single or repeated dosesof CHF6523.
- Trial name
- CHF6523 (NCT04032535)
- Testing
- CHF6523
- Where
- United Kingdom
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Adenosine Deaminase Severe Combined Immunodeficiency
Registry Study of Revcovi Treatment in Patients With ADA-SCID
This registry study is being conducted in patients with adenosine deaminase severe combined immune deficiency (ADA-SCID) who require enzyme replacement therapy (ERT) treatment with Revcovi.
- Trial name
- NCT03878069
- Testing
- elapegademase-lvlr
- Where
- 14 sites in United States
- Volunteers
- 32 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABA
The purpose of this phase IV Study is to compare the efficacy of CHF5993 (BDP/FF/GB 100/6/12.5 pMDI) on uncontrolled asthma subjects, versus CHF1535 (BDP/FF 200/6 pMDI).
- Trial name
- MiSTIC (NCT05018598)
- Testing
- Administration via pressurized metered dose inhaler (pMDI)
- Where
- Hungary
- Volunteers
- 320 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Mucociliary Clearance
Study to Assess the Effect of the New HFA-152a Propellant on Mucociliary Clearance
The primary objective of this study was to assess the effect of multiple doses of the HFA-152a propellant and the HFA-134a propellant on mucociliary clearance (MCC).
- Trial name
- NCT05875025
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Doses and QVAR®
The study is being conducted to compare the pharmacokinetic (PK) of BDP (and its main active metabolite B17MP), FF, and GB between CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI and CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI (pressurized…
- Trial name
- NCT05898984
- Testing
- Test product (T):CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI, Reference product 1 (R1): CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI, Reference product 2 (R2): BDP HFA (QVAR REDIHALER®, BDP 80 μg)
- Where
- Belgium
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma
Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.
- Trial name
- NCT00476268
- Testing
- beclomethasone/formoterol (100/6µg) pMDI, Beclometasone dipropionate 250 µg/unit dose pMDI, Formoterol powder 12 µg/unit dose
- Volunteers
- 824 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
A Study to Compare the Effects of Two Propellants in Adults With Mild Asthma
This is a Phase IIa, multicentre, single dose, randomised, double blind, controlled, 2 way cross-over study to evaluate the potential for bronchoconstriction of the new HFA-152a propellant (single dose) versus the marketed…
- Trial name
- NCT05472662
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- Chiesi Farmaceutici S.p.A.