Chiesi Farmaceutici S.p.A.: Pulmonary Disease, Chronic Obstructive trials

The registry lists 55 Pulmonary Disease, Chronic Obstructive studies with Chiesi Farmaceutici S.p.A. as lead sponsor. 5 are open to participants now and 7 have results posted.

Phase 1 18Phase 2 15Phase 3 16Phase 4 2No phase 8(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD PatientsRecruitingNCT07406048
• Utilising Hull Lung Health Study Data to Investigate the Performance of TidalSense Diagnostic Algorithms to Identify COPD and Pre-COPD Among Participants in the FRONTIER Programme.Not yet recruitingNCT06788613
• Investigation of Fixed Triple Inhaled Combination in Asthmatic Patients, in a Real-life SettingRecruitingNCT06678191
• Impact of Fixed TRIple Therapy With Beclometasone/Formoterol/Glycopyrronium DPI (Trimbow® in NEXThaler Device) in Chronic Obstructive PulmoNary Disease in rEal-world Settings: Health-related Quality of Life Patient' eXpectations and characterisTics: the TriNEXT StudyRecruitingNCT05948891
• PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)RecruitingNCT05652439
• Functional Respiratory Imaging Study (DARWiIN)CompletedNCT04876677Phase 3Results posted
• Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast) in Healthy SubjectsCompletedNCT04756960Phase 1Results posted
• Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (FORSYYN)CompletedNCT03888131Phase 3Results posted
• Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD) (TRIVERSYTI)CompletedNCT03197818Phase 3Results posted
• A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary DiseaseCompletedNCT03084796Phase 2Results posted
• Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPDCompletedNCT01917331Phase 3Results posted
• A Study in Patients With Chronic Obstructive Pulmonary DiseaseCompletedNCT01245569Phase 3Results posted
• Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) StudyCompletedNCT06892756Phase 1
• Real-World Effectiveness of a Triple Combination BDP/FF/GB in a Single Pressurised Metered Dose Inhaler in COPD Patients (TRIPHY)CompletedNCT06480890
• Effect of Erythromycin on the Absorption, Metabolism and Elimination of CHF6001 in Healthy VolunteersCompletedNCT06395610Phase 1
• A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)CompletedNCT05830071Phase 1
• NEXThaleR Real-world Study Assessing the EffectivenesS of BDP/FF/G Fixed triPle cOmbiNation on Symptom scorEs in COPD PatientsCompletedNCT05743608
• PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy VolunteersCompletedNCT05431426Phase 1
• Clinical Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and Severe Liver Impairment in Comparison With Matched Healthy Control SubjectsCompletedNCT05373953Phase 1
• CHF5993 and CHF1535 pMDI on Lung Hyperinflation and Exercise Endurance Time in Subjects With COPDCompletedNCT05097014Phase 4
• Investigation of the Effect of Inhibition of CYP3A4/5 by Itraconazole on the PK of CHF6001 (Tanimilast)CompletedNCT04739774Phase 1
• 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)TerminatedNCT04636814Phase 3
• 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)TerminatedNCT04636801Phase 3
• A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPDCompletedNCT04320342Phase 3
• Triple Therapy in Real-life: Impact on Adherence and Health Status (TRITRIAL)CompletedNCT03963167
• PK of BDP/FF/GB Single-inhaler Triple Therapy in Japanese vs. CaucasiansCompletedNCT03859414Phase 1
• Lung Deposition of TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD PatientsTerminatedNCT03795350Phase 1
• Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD)CompletedNCT03590379Phase 2
• 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 CHF6366CompletedNCT03378648Phase 1/2
• Functional Respiratory Imaging Study (FRI)CompletedNCT03268226Phase 3
• A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPDCompletedNCT02986321Phase 2
• Lung Deposition of Beclometasone Dipropionate/Formoterol Fumarate/Glycopyrronium Bromide Administered Via pMDI in Healthy, Asthmatic and COPD PatientsCompletedNCT02975843Phase 1
• A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of CHF6297 in Healthy Subjects and Patients With COPDTerminatedNCT02815488Phase 1/2
• Study to Evaluate Efficacy/Safety of 4 Doses of CHF5259 Via Dry Powder Inhaler (DPI) in Patients With COPDCompletedNCT02680197Phase 2
• 2-arm Parallel Group Study of Fixed Combination of CHF 5993 vs Ultibro® in COPD PatientsCompletedNCT02579850Phase 3
• Non Inferiority of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) Versus Combination of Fluticasone Furoate (FlF)/Vilanterol (VI) + Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD)CompletedNCT02467452Phase 3
• A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001CompletedNCT02386761Phase 1
• Efficacy and Safety of Glycopyrrolate Bromide of COPD PatientsCompletedNCT02189577Phase 2
• A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.CompletedNCT02040597Phase 1
• Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary DiseaseCompletedNCT01911364Phase 3
• Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers (HV)CompletedNCT01703052Phase 1
• Phase II Study to Evaluate the Cardiac Safety of 2 Doses of CHF5993 Both Combined With CHF1535 BID Versus CHF1535 BID in Patients With Moderate to Severe COPDCompletedNCT01584505Phase 2
• Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and GlycopyrrolateCompletedNCT01476813Phase 2
• A Study in Patients With Chronic Obstructive Pulmonary Disease (FAIR)TerminatedNCT01351792Phase 3
• Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD PatientsCompletedNCT01344655Phase 4
• Safety and Efficacy Study of Glyco pMDI After Single and Repeated AdministrationCompletedNCT01176903Phase 1/2
• Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD PatientsCompletedNCT01176747Phase 1/2
• Formoterol-HFA 3-month Study in Chronic Obstructive Pulmonary Disease (COPD) PatientsCompletedNCT00972140Phase 3
• BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)CompletedNCT00929851Phase 3
• Safety and Efficacy Study of Treatment With Single Doses of CHF 4226 pMDI in Patients With Chronic Obstructive Pulmonary Disease (COPD)CompletedNCT00782535Phase 2
• Evaluation of Possible Effects on the QTc Interval of CHF 4226 pMDI in Healthy VolunteersCompletedNCT00777595Phase 1
• Formoterol Via pMDI HFA-134a Propellant or DPI in Partially Reversible Chronic Obstructive Pulmonary Disease (COPD)CompletedNCT00742248Phase 2
• Confirmatory Dose Finding Study of 2 Dosages of CHF 4226 pMDI (Carmoterol) in Patients With COPDCompletedNCT00640484Phase 2
• Dose Finding Study of CHF 4226 for Treating Patients With COPDCompletedNCT00605891Phase 2
• Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPDCompletedNCT00476099Phase 3