Clinical trials: sponsored by Chiesi Farmaceutici S.p.A.
- Lead sponsor (exact) Chiesi Farmaceutici S.p.A.
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Chronic Obstructive Pulmonary Disease
A Study in Patients With Chronic Obstructive Pulmonary Disease
The primary objective of the study was to demonstrate the superiority of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), in terms of pulmonary function (AUC0-30min standardized by time of change…
- Trial name
- FUTURE (NCT01245569)
- Testing
- Beclomethasone Dipropionate - Formoterol, Fluticasone - Salmeterol
- Where
- 68 sites in Denmark, France and 8 more
- Volunteers
- 419 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma.
Primary Objective To demonstrate the non-inferiority of Foster® NEXThaler® 100/6 µg versus (vs.) Foster® pressurised metered dose inhaler (pMDI) 100/6 µg in terms of pulmonary function (change from baseline to the entire…
- Trial name
- FORTUNE (NCT03453112)
- Testing
- Foster 100/6µg NEXThaler, Foster 100/6µg pMDI
- Where
- 51 sites in China
- Volunteers
- 494 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease (COPD)
Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD
Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of beclometasone + formoterol + glycopyrrolate (BDP/FF/GB) administered via…
- Trial name
- TRILOGY (NCT01917331)
- Testing
- Beclometasone/Formoterol/Glycopyrrolate, Beclometasone/Formoterol
- Where
- Hungary
- Volunteers
- 1,368 people
- Sponsor
- 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.