Clinical trials: sponsored by Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
Functional Respiratory Imaging Study (DARWiIN)
The objective of this clinical study was to evaluate the tolerability, safety, and efficacy of stepping up from fluticasone propionate (FP)/salmeterol (SLM) dry-powder inhaler (DPI) (SERETIDE™ DISKUS™) to extrafine beclometasone…
- Trial name
- DARWiIN (NCT04876677)
- Testing
- Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB)
- Where
- 8 sites in Belgium, Hungary
- Volunteers
- 25 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Study in Adult Patients With Moderate to Severe Asthma
This study assessed the influence of pink vs. white pressurized metered-dose inhaler (pMDI) actuators on asthma symptoms perception. There was no prespecified primary objective.
- Trial name
- FEEL (NCT04886999)
- Testing
- Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A), Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)
- Where
- 10 sites in Italy
- Volunteers
- 78 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease
Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease
The objective of CLI-06657AA1-04 (formerly PB-102-F60) was to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa administered intravenously every other week in adult Fabry…
- Trial name
- NCT03566017
- Testing
- pegunigalsidase alfa
- Where
- 30 sites in United States, Australia and 11 more
- Volunteers
- 97 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Pulmonary Hypertension Associated With Interstitial Lung Disease
Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
This Phase 3 study is designed as a 24-week randomized, double-blind, placebo-controlled period (PCP) followed by a 144-week long-term extension (LTE) period.
- Trial name
- SERANATA (NCT07181382)
- Testing
- Seralutinib, Generic Dry Powder Inhaler
- Where
- 4 sites in United States, Israel
- Volunteers
- 480 people
- Sponsor
- GB002, Inc.
Asthma
Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients
Primary objective To show the superiority of CHF 1535 (BDP/FF) pMDI (800/24 μg per day) over BDP HFA pMDI (800 μg per day) in terms of change from baseline to the entire treatment period in average pre-dose morning peak…
- Trial name
- FORCE (NCT01577082)
- Testing
- CHF1535 200/6 µg pMDI, BDP HFA 100 µg pMDI
- Where
- 66 sites in Bulgaria, Czechia and 7 more
- Volunteers
- 542 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease, Pregnancy
Maternal and Postnatal Outcomes Study (MOS): A Global Observational Registry Assessing the Safety of Elfabrio® in Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding
The goal of this observational registry is to evaluate the safety and outcomes of pregnancy and lactation in women with Fabry disease who are exposed to pegunigalsidase alfa within 30 days prior to conception and/or during…
- Conditions
- Fabry Disease, Pregnancy, Pregnancy Complications
- Trial name
- MOS (NCT06941025)
- Testing
- Not applicable- observational study
- Where
- 5 sites in United States, Germany and 3 more
- Volunteers
- 10 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease
Study to Evaluate the Safety, PK, PD, and Efficacy of PRX-102 in Japanese Patients With Fabry Disease
The aim of this study is to evaluate the safety and efficacy of pegunigalsidase alfa in Japanese patients (adults and adolescents) affected by Fabry disease.
- Trial name
- RISE (NCT05710692)
- Testing
- PRX-102 1 mg/kg every 2 weeks, PRX-102 2 mg/kg every 4 weeks
- Where
- 10 sites in Japan
- Volunteers
- 16 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Respiratory Distress Syndrome, Newborn
Premedication for Less Invasive Surfactant Administration Study (PRELISA)
The purpose of this study is to conduct a double blinded randomized control trial to determine the safety and efficacy of using IV fentanyl and atropine prior to Less Invasive Surfactant Administration (LISA) procedure in preterm…
- Trial name
- PRELISA (NCT05065424)
- Testing
- IV Atropine and Fentanyl Premedication Arm
- Where
- United States
- Volunteers
- 58 people
- Sponsor
- University of Texas Southwestern Medical Center
COPD
Triple Therapy in Real-life: Impact on Adherence and Health Status (TRITRIAL)
The mean objectives are to evaluate the impact of BDP/FF/G fixed combination on health-status and adherence
- Trial name
- NCT03963167
- Testing
- BDP/FF/G fixed combination
- Where
- Italy
- Volunteers
- 661 people
- Sponsor
- Chiesi Italia
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.
Alpha-1 Antitrypsin Deficiency (AATD)
Effect Of Pulmonary Rehabilitation in Patients With Alpha-1 Antitrypsin Deficiency
This single-center, longitudinal, observational, prospective study aims to assess the applicability, adherence, and clinical impact of the Active Cycle of Breathing Technique (ACBT) with augmented reality support in patients with…
- Trial name
- RRALFA1 (NCT07242079)
- Testing
- Pulmonary Rehabilitation
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- University of Parma
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.