Clinical trials: sponsored by Chiesi Farmaceutici S.p.A.
COPD (Chronic Obstructive Pulmonary Disease)
Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD) (TRIVERSYTI)
Primary Objective To demonstrate the superiority of CHF 5993 pressurised metered dose inhaler (pMDI) over Symbicort® Turbuhaler® in terms of pulmonary function (change from baseline in pre-dose morning forced expiratory volume in…
- Trial name
- TRIVERSYTI (NCT03197818)
- Testing
- CHF 5993 100/6/12.5 µg, 160 µg budesonide + 4.5 µg formoterol fumarate
- Where
- 64 sites in China, South Korea and 1 more
- Volunteers
- 708 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid
Compare the superiority of CHF 1535 versus CHF 718 in subjects with asthma who are on medium or high dose inhaled corticosteroids.
- Trial name
- FORCE2 (NCT05292586)
- Testing
- Beclomethasone Dipropionate/Formoterol Fumarate, Beclomethasone Dipropionate
- Where
- 91 sites in United States
- Volunteers
- 1,377 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Familial Partial Lipodystrophy
Open-label Extension Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
This Phase 3 study is an Open Label Extension of the APG-20 Study To Evaluate the Long-term Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects with Partial Lipodystrophy
- Trial name
- NCT06679270
- Testing
- Metreleptin
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Generalised Lipodystrophy, Partial Lipodystrophy
MEASuRE: Metreleptin Effectiveness And Safety Registry
The study is a post-authorization, prospective, voluntary registry of patients treated with commercial metreleptin including, but not limited to, patients in the US and EEA.
- Trial name
- MEASuRE (NCT02325674)
- Testing
- Metreleptin
- Where
- 28 sites in United States, France and 3 more
- Volunteers
- 100 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease
Observational Study on Long-term Use of Pegunigalsidase Alfa in Fabry Patients in a Real-world Setting
PEGASO is an observational study designed to collect prospective data on the effectiveness and safety of pegunigalsidase alfa in adult patients with Fabry disease, being treated or planning to start treatment, under real-world…
- Trial name
- PEGASO (NCT07109375)
- Testing
- pegunigalsidase alfa
- Where
- 7 sites in Italy
- Volunteers
- 75 people
- Sponsor
- Chiesi Italia
Asthma
Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists
This is a study comparing CHF 5993 pMDI HFA-152a with CHF 1535 pMDI HFA-134a in Chinese patients with asthma uncontrolled on medium doses of ICS+LABA.
- Trial name
- TRICHECO (NCT07546981)
- Testing
- Experimental: Participant Group CHF 5993 pMDI HFA-152a, Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a
- Where
- 2 sites in China
- Volunteers
- 554 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Healthy Volunteers
A Study to Compare How CHF10196 (Florensocatib) is Absorbed Into the Blood When Given Alone and With a Drug That Reduces Stomach Acid in Healthy Male Participants
This Phase 1 study evaluates the effect of pantoprazole (a proton pump inhibitor) on the pharmacokinetics (PK) of CHF10196 (Florensocatib) in healthy male participants.
- Trial name
- NCT07683793
- Testing
- CHF10196, Pantoprazole
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)
Evaluate the superiority of CHF 5993 200/6/12.5 µg pressurised metered dose inhaler (pMDI) (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) versus CHF 1535 200/6 µg…
- Trial name
- TRIGGER (NCT02676089)
- Testing
- CHF 5993 200/6/12.5 µg, CHF 1535 200/6 µg, CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg
- Where
- 244 sites in Argentina, Belarus and 15 more
- Volunteers
- 1,437 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA
Evaluate the superiority of CHF 5993 100/6/12.5 µg Pressurised Metered Dose Inhaler (pMDI) (fixed combination of extrafine beclometasone dipropionate (BDP) plus formoterol fumarate (FF) plus glycopyrronium bromide [GB]) versus…
- Trial name
- TRIMARAN (NCT02676076)
- Testing
- CHF 5993 100/6/12.5, CHF 1535 100/6 µg
- Where
- Germany
- Volunteers
- 1,155 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant.
- Trial name
- TRECONY (NCT07301736)
- Testing
- CHF5993 pMDI with HFA-152a, CHF5993 pMDI with HFA-134a, CHF718 pMDI with HFA-134a
- Where
- 167 sites in Argentina, Bosnia and Herzegovina and 12 more
- Volunteers
- 780 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Bronchiectasis
A Study to Evaluate the Efficacy and Safety of CHF10196 Tablets (Florensocatib) Compared With Placebo in Male and Female Participants 12 to 85 Years of Age With Bronchiectasis
This study aims to find out whether the tablet CHF10196 is safe and effective for people with non-cystic fibrosis bronchiectasis, a long-term lung disease that causes widened airways, mucus buildup, infections, and flare ups of…
- Trial name
- FABLE (NCT07577804)
- Testing
- CHF10196 tablets (florensocatib)
- Volunteers
- 904 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Partial Lipodystrophy
Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL
This is a Phase III, double-blind, placebo-controlled, safety and efficacy study of daily SC metreleptin in subjects with Partial Lipodystrophy.
- Trial name
- METRE-PL (NCT05164341)
- Testing
- metreleptin
- Where
- 31 sites in United States, Belgium and 7 more
- Volunteers
- 69 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Fabry Disease
Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients
The objective of CLI-06657AA1-03 (formerly PB-102-F51) is to evaluate the long-term safety, tolerability, and efficacy of 2 mg/kg pegunigalsidase alfa administered intravenously every four weeks in adult Fabry patients who have…
- Trial name
- NCT03614234
- Testing
- pegunigalsidase alfa
- Where
- 14 sites in United States, Belgium and 5 more
- Volunteers
- 29 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Pulmonary Arterial Hypertension
Exercise Intervention as an Adjunct to Medical Therapy in Newly Diagnosed Patients With Pulmonary Arterial Hypertension
The goal of this clinical trial is to learn if an exercise programme started shortly after diagnosis improves the fitness and mental wellbeing of patients with pulmonary hypertenion over and above medication alone.
- Trial name
- NCT07366879
- Testing
- Home-based, remotely delivered, supervised Exercise programme
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Golden Jubilee National Hospital
Chronic Obstructive Pulmonary Disease
Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (FORSYYN)
Primary Objective To demonstrate that CHF 1535 pMDI is non-inferior to Symbicort® Turbohaler® in terms of pulmonary function (change from baseline in pre-dose morning FEV1 at Week 24) in patients with COPD.
- Trial name
- FORSYYN (NCT03888131)
- Where
- 53 sites in China
- Volunteers
- 750 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Study on Foster Efficacy Maintenance and Reliever vs Foster Maintenance + Salbutamol Reliever in Asthmatics (MART2)
Primary objective: The primary objective of the study was to compare the efficacy of Maintenance and Reliever Therapy (MART) with Foster® 100/6 μg (one inhalation bid) plus additional inhalations as needed, with the standard…
- Trial name
- NCT00861926
- Testing
- Salbutamol, Beclomethasone dipropionate + Formoterol
- Where
- 206 sites in Bulgaria, Croatia and 12 more
- Volunteers
- 1,714 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
COVID - 19
Effect of Pulmonary Rehabilitation and Physical Activity on COVID-19 Long-Term Symptoms (PuReCOVID)
This single-center, observational, longitudinal, retrospective and prospective study investigates the impact of Active Cycle of Breathing Technique (ACBT) and moderate daily physical activity on symptoms associated with long…
- Trial name
- PuReCOVID (NCT07046442)
- Testing
- Pulmonary Rehabilitation
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- University of Parma
Asthma
Efficacy of LAMA Added to ICS in Treatment of Asthma (ELITRA)
Primary objective The primary objective was to evaluate the superiority of CHF 5259 (glycopyrronium bromide [GB]) in a pressurised metered dose inhaler (pMDI) (50 μg total daily dose) versus placebo in terms of forced expiratory…
- Trial name
- ELITRA (NCT02296411)
- Testing
- CHF 5259 12.5 µg + Qvar
- Where
- 28 sites in Bulgaria, Germany and 3 more
- Volunteers
- 98 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
COPD (Chronic Obstructive Pulmonary Disease)
Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients
This multicenter, retrospective-prospective, cohort study aims to evaluate the effectiveness and safety of Extra-fine Beclometasone Diproprionate/Formoterol Fumarate/Glycopyrronium Bromide (EF-BDP/FF/GB) therapy in adults with…
- Trial name
- RETRIBUTE (NCT07406048)
- Testing
- BDP/FF/GB (100ug/6ug/12.5ug)
- Where
- Brazil
- Volunteers
- 396 people
- Sponsor
- Chiesi Farmaceutica Ltda.
Asthma
Triple in Asthma Dose Finding
Primary objective The primary objective was to evaluate the efficacy of a free combination of CHF 5259 at 3 dose levels plus Foster® 100/6 μg in a pMDI by comparison with Foster® 100/6 μg in terms of forced expiratory volume in…
- Trial name
- Triskel (NCT02127866)
- Testing
- CHF 5259 plus Foster 100/6 µg, Foster 100/6 µg (four puffs BID)
- Where
- 44 sites in Bulgaria, Germany and 4 more
- Volunteers
- 211 people
- Sponsor
- Chiesi Farmaceutici S.p.A.