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Aree Terapeutiche

Condizione

Codice Prodotto

ID Studio

Fase Studio

Stato Studio

RESPIRATORY

Asthma

CHF5993

CLI-05993AB6-07

2

Completed

 A Single-dose, Randomised, Double-blind, Controlled, 2-way Cross-over Study to Assess the Potential for Bronchoconstriction of the New Propellant HFA-152a Versus the Marketed HFA-134a Propellant, in Adult Subjects With Mild Asthma.

RARE DISEASES

Fabry disease

CHF6657

DFIDM-2001

Observational

Completed

 Global Burden and Treatment Trajectiories in Italian Patients With Fabry Disease: a Retrospective, Longitudinal and Cross-sectional Study.

TRANSPLANTATION

Renal And Liver Failure - Solid Organ Transplant (SOT)

CHF6235

DFIDM-1701

Observational

Completed

 The Adherence of Immunosuppressive Therapy Including Tacrolimus Once Daily in a Cohort of Kidney Transplant Recipients: an Italian Prospective Observational Study.

RESPIRATORY

Asthma

CHF1535

CLI-01535AA0-02

3

On-going

 An Exploratory, Double-blind, Randomised, Multicenter, Psychopharmacological Study in Adult Patients With Moderate to Severe Asthma to Compare Two Pressurised Metered-Dose Inhalers (pMDIs) on Patients' Perception of Asthma Symptoms.

RESPIRATORY

Asthma

CHF1535

CHIT -2101

Observational

On-going

 Effects of beclometasone dipropionate/formoterol fumarate fixed combination administered with the NEXT(haler) in a rEal-World study on The probability Of improving the asthma coNtrol status after 6 months of treatment. The NEWTON study.

RESPIRATORY

Asthma

CHF5993

CLI-05993AB1-06

4

On-going

 A 26 week, randomized, double blind, multinational, multicentre, active controlled, 2-arm parallel group Trial comparing CHF 5993 100/6/12.5 μg pMDI (fixed combination of extrafine formulation Beclometasone Dipropionate plus Formoterol Fumarate plus Glyco

RESPIRATORY

COPD

CHF5993

CLI-05993AA3-06

3

On-going

 A Phase III, 52-week, Multinational, Multicenter, Randomized, Double-blind, 2-arm Parallel Group Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrron

RARE DISEASES

Fabry disease

CHF6657

CLI-06657AA1-05

Observational

Completed

 Fabry Patient's Experience Of PegunigaLsidasE Alfa Monthly Infusion (PEOPLE).

RESPIRATORY

COPD

CHF5993

CLI-05993AA1-17

4

On-going

 A Double Blind, Multicentre, Randomised, Placebo-Controlled, 3-Way Cross-Over Study To Evaluate The Effect Of A Triple Combination Of Beclometasone Dipropionate And Formoterol Fumarate Plus Glycopyrronium (CHF5993) And A Dual Combination Of Beclometasone D

RESPIRATORY

Asthma

CHF5993

CLI-05993AB2-03

1

Completed

 Open-label, randomized, 3-way cross-over, placebo controlled, single dose clinical pharmacology study in asthmatic patients after inhalation of CHF 5993 200/6/12,5 µg pMDI using the standard actuator with or without AeroChamber Plus® Flow-Vu VHC spacer.

RARE DISEASES

ADA-SCID

CHF6814

CLI-06814AA1-01

Observational

On-going

 Single Arm, Open-Label, Multicenter, Registry Study of Revcovi (Elapegademase-lvlr) Treatment in ADA-SCID Patients Requiring Enzyme Replacement Therapy.

RESPIRATORY

COPD

CHF5993

CLI-05993BA1-08

3

Completed

 Effect of step-up from non-extrafine ICS/LABA DPI to extra fine triple therapy with CHF5993 DPI on airway geometry and lung ventilation using FRI in patients with advanced COPD (DARWiIN).

RESPIRATORY

COPD

CHF6001

CLI-06001AA1-05

3

On-going

 A 52-week, randomized, double-blind, double-dummy, placebo- and active- controlled (Roflumilast, Daliresp® 500µg), parallel group, study to evaluate the efficacy and safety of two doses of CHF6001 DPI add-on to maintenance triple therapy in subjects with

RESPIRATORY

COPD

CHF6001

CLI-06001AA1-04

3

On-going

 A 52-week, randomized, double-blind, placebo-controlled, parallel-group, study to evaluate the efficacy and safety of two doses of CHF6001 DPI add-on to maintenance triple therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD) and Chronic Br

RESPIRATORY

Asthma

CHF1535

CLI-01535AA0-01

Observational

Completed

 A multi-centre multi-country Prospective obseRvatIonal study on patterns of care of Mild asthmatic patiEnt (PRIME).

SPECIAL CARE

Diabetic Neuropathic Foot Ulcers (DFU)

CHF6467

CLI-06467AA1-01

1/2

Completed

 A randomised, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CHF6467 after single and repeated ascending doses in subjects with diabetic neuropathic foot ulcers (DFU).

NEONATOLOGY

Neonatal Opioid Withdrawal Syndrome

CHF6563

CLI-06563AA1-02

2

Prematurely ended

 A Phase II, Multicenter, Double Blind, Double Dummy, Randomized, 2 Arms Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome.

SPECIAL CARE

Thrombosis

CANGRELOR

DFIDM-1801

Observational

Completed

 A multi centre, observational, prospective cohort study including patients with acute coronary syndromes undergoing percutaneous coronary intervention who receive Cangrelor i.v. transitioning to either clopidogrel, prasugrel or ticagrelor per os.

NEONATOLOGY

Respiratory Distress Syndrome (RDS)

CHF1534

CLI-050000-04

2

Prematurely ended

 Multicenter, Open-label, Randomised Trial to Assess the Efficacy and Tolerability of Poractant Alfa (Porcine Surfactant, Curosurf®) in Hospitalized Patients With SARS-COV-19 Acute Respiratory Distress Syndrome (ARDS).

SPECIAL CARE

Catheter Occlusion/Thrombosis

CUSA-081

CUSA-081-HEM-01

3

On-going

 A Phase 3, Randomized, Double-Blind, Active and Placebo-Controlled Study on the Use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs)

RESPIRATORY

Asthma

CHF5993

CLI-05993CB1-01

2

Completed

 A single-dose, uncontrolled, open label, non-randomized, clinical pharmacology study of CHF 5993 100/6/12.5 µg pMDI (fixed combination of beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) in asthmatic adolescent patients and

RARE DISEASES

Alpha-mannosidosis

CHFLMZYM

CLI-LMZYMAA1-12

Observational

On-going

 The Alpha-Mannosidosis Registry: a Multi-Centre, Multi-Country, Non-interventional, Prospective Cohort, in Alpha-Mannosidosis Patients.

SPECIAL CARE

Thrombosis

CANGRELOR

MDCO-CAN-15-01

1

Completed

 A Prospective, Open-Label, Single-Arm, Multi-Center Study To Assess The Pharmacokinetics/Pharmacodynamics (PK/PD) And Safety Of Different Cangrelor Doses In Neonatal Subjects At Risk Of Thrombosis

RESPIRATORY

COPD

CHF5993

DFIDM-1802

Observational

Completed

 The Impact on the Health Status and Adherence in a Real-life Setting of Italian Patients With Chronic Obstructive Pulmonary Disease in Treatment With Trimbow® pMDI b.i.d.: a 12-month Prospective Observational Study

RESPIRATORY

Asthma

CHF1535

CLI-01535AA1-01

4

Completed

 12-weeks randomised controlled clinical trial to explore the effect of a smartphone application connected to an Add-on DeVICE system (Propeller Health) fitted on pMDI inhaler on adherence to take medications as prescribed and clinical outcomes in difficult

RESPIRATORY

Asthma

CHF6532

CLI-06532AA1-01

3

Prematurely ended

 A 52 week, randomised, double blind, multinational, multicentre, 4-arm parallel group trial to assess the efficacy and safety of 3 doses of CHF 6532 (10, 25 or 50 mg BID) compared to placebo on top of standard of care in subjects with uncontrolled severe e

RESPIRATORY

Asthma

CHF6532

CLI-06532AA1-03

1

Completed

 A clinical pharmacology study to evaluate the CHF 6532 linearity after single oral administrations of 25, 50, 100 and 200 mg of a tablet formulation followed by an evaluation of the pharmacokinetic at steady state following the repeated open label b.i.d. a

RESPIRATORY

Asthma

CHF1535

CLI-01535AC1-03

2

Prematurely ended

 Comparison of Two Formulations of Beclometasone/Formoterol pMDI on Respiratory System Impedance Using Impulse Oscillometry in Asthmatic Patients.

RESPIRATORY

Asthma and COPD

CHF5993

CLI-05993AA1-20

1

Prematurely ended

 Open Label, Uncontrolled, Non-Randomized, Single Dose, Scintigraphic Study to Investigate Lung Deposition of Inhaled 99mtc Radiolabelled TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD Patients.

RESPIRATORY

COPD

CHF5993

CLI-05993BA1-02

2

Completed

 A Phase II, Multicentre, Randomised, Double-Blind, Double-Dummy, Active controlled, 3-Way Cross-Over Study to Evaluate the Efficacy of CHF 5993 Administered via Dry Powder Inhaler (DPI) versus CHF 5993 via Pressurized Metered Dose Inhaler (pMDI) and CHF 15

TRANSPLANTATION

Renal And Liver Failure - Solid Organ Transplant (SOT)

CHF6235

DFIDM-1501

2

Completed

 ENVARSUS® Tablets Administered once Daily in Combination with Everolimus in Elderly De-Novo Kidney Transplant Recipients: Open-Label, Multicentre, Single-Arm, Pharmacokinetic and Clinical Study.

TRANSPLANTATION

Renal And Liver Failure - Solid Organ Transplant (SOT)

CHF6235

CCD-06235AA1-02

4

Completed

 Open-Label, Multicentre, Randomized Clinical Trial to Compare the Pharmacokinetics of ENVARSUS® Tablets and ADVAGRAF® Capsules Administered once Daily in Adult De-Novo Kidney Transplant Patients.

TRANSPLANTATION

Renal And Liver Failure - Solid Organ Transplant (SOT)

CHF6235

CCD-06235AA1-01

4

Completed

 Multicentre, Open Label, Randomized, Two-arm, Parallel-group Study to Assess Efficacy and Safety of ENVARSUS® Compared with Tacrolimus Used as Per Current Clinical Practice in the Initial Maintenance Setting in De Novo Kidney Transplant Patients.

RESPIRATORY

Cystic Fibrosis

CHF6333

CCD-06333AA1-01

1

Completed

 A Phase I, Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 after Single and Repeated Ascending Doses in Healthy Male Subjects.

RESPIRATORY

Cystic Fibrosis

CHF1538

CMA-0631-PR-0010 Extension

3

Completed

 A Single Arm 48-Week Follow-on Safety Study to the Core Study (A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4Ml U

RESPIRATORY

Cystic Fibrosis

CHF1538

CMA-0631-PR-0010 CORE

3

Completed

 A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of tobrineb®/Actitob®/Bramitob® (tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients with Cys

RESPIRATORY

Cystic Fibrosis

CHF1538

CCD-0908-PR-0029

1

Completed

 Pharmacokinetic Study of Bramitob® Administered for Inhalation by Pari eFlow® Rapid Electronic Nebulizer vs Pari LC® Plus Nebulizer Coupled with the Pari Turbo Boy® N Compressor in Cystic Fibrosis Patients infected with Pseudomonas Aeruginosa.

RESPIRATORY

Cystic Fibrosis

CHF1538

CCD-01538AA1-04

Observational

Completed

 A Long Term Prospective Observational Study of the Safety and Tolerability of Bramitob® Administered Twice Daily Over Three 28-Day on /28-Day off Cycles to Patients with Cystic Fibrosis Having Severely Compromised Lung Function

RESPIRATORY

CROUP (Acute Laryngotracheobronchitis)

CHF718

MC/PR/1404/003/09

3

Prematurely ended

 Multicentre, Randomized, Double-Blind, Placebo-Controlled, Two-Arm Parallel Groups Study Design to Demonstrate the Efficacy and Tolerability of a Single Dose of BDP Suspension for Nebulisation 1600 μg vs Placebo in the Treatment of Children Aged 6 Month

RESPIRATORY

COPD

CHF1531

DM/PR/3301/002/03

2

Completed

 Double Blind, Double Dummy, Multicentre, Randomised, Placebo- Controlled, Crossover Design Clinical Trial of 12 ¼μg (Single Dose and Repeated Doses) Formoterol Fumarate Administered via pMDI with HFA-134a Propellant or DPI (Aerolizertm Inhaler) in Pa

RESPIRATORY

COPD

CHF1535

MC/PR/033011/003/05

3

Completed

 Double Blind, Double Dummy, Randomised, Parallel Group, Monocentric Clinical Trial on the Effects of CHF 1535 MDI or Seretide DPI on Lung Hyperinflation and Exercise Tolerance in Patients with COPD A Pilot Study.

RESPIRATORY

COPD

CHF6302

CCD-06302AA1-02

1

Completed

 An Open Label, Randomized, Repeated-Dose, 3-Way Crossover Study to Investigate the Pharmacokinetic Interaction and the Safety of Inhaled CHF 5259 (Glycopyrronium Bromide) and CHF 6001 Administered in Healthy Subjects Via A Multi-Dose Reservoir NEXThaler®

RESPIRATORY

COPD

CHF6302

CCD-06302AA1-01

2

Completed

 Randomised, Double Blind, Placebo-Controlled, incomplete Block, 3-Way Cross-Over Study to Evaluate Efficacy and Safety of 4 Doses of Glycopyrronium Bromide (CHF5259) DPI in Moderate to Severe Patients with COPD.

RESPIRATORY

COPD

CHF6297

CCD-06297AA1-01

1/2

Prematurely ended

 A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of CHF 6297 after Single and Repeated Ascending Doses in Healthy Male Subjects Followed by A Repeated Dose in COPD Patients and A 2-Way, Cross

RESPIRATORY

COPD

CHF6001

CCD-1201-PR-0079

2

Completed

 A Randomised, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Three-Way Crossover Study to Evaluate the Safety, Tolerability and Efficacy of 28-Day Inhaled CHF 6001 DPI (1200 microgrammes Daily) in Subjects with COPD.

RESPIRATORY

COPD

CHF6001

CCD-1006-PR-0048

1

Completed

 A Placebo-Controlled Double-Blind Single and Repeated Ascending Dose Study to Investigate the Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers.

RESPIRATORY

COPD

CHF6001

CCD-06001AA1-10

2

Completed

 A Randomised, Double-Blind,Placebo Controlled, Repeated Dose, Three-Way Crossover Study to Evaluate the Pharmacodynamics, Pharmacokinetics and Safety of Two Doses of CHF6001 DPI in Subjects with Moderate, Severe COPD.

RESPIRATORY

COPD

CHF6001

CCD-06001AA1-01

2

Completed

 A 24-Week, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 6001 DPI in Patients with Chronic Obstructive Pulmonary Disease (COPD) o

RESPIRATORY

COPD

CHF6001

CCD-06001AA1-08

1

Completed

 A Phase I Randomised, Double-Blind, Placebo-Controlled Study of Single and Repeated Ascending Doses in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6001.

RESPIRATORY

COPD

CHF6001

CCD-06001AA1-07

1

Completed

 Open-Label, Randomized, 2-Way Cross-Over, Single Dose Study in Healthy Volunteers to Investigate the Pharmacokinetics of CHF 6001 DPI Administered Using the Multi-Dose Reservoir NEXThaler® Device or the Capsule for oral Inhalation Via Aerolizer® Device.

RESPIRATORY

COPD

CHF5993

CCD-05993AA1-13

1

Completed

 An Open, Single and Multiple Dose Study to Evaluate the Pharmacokinetics of CHF 5993 Inhalation Aerosol (Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrronium Bromide) 100/6/12.5 μg Fixed Combination in Healthy Chinese Subjects.

RESPIRATORY

COPD

CHF5993

CCD-05993AA1-16

3

Completed

 Open Label, Prospective, Exploratory Study to Investigate the Effect of Inhaled CHF5993 pMDI on Central and Peripheral Airway Dimensions in COPD Patients by Functional Respiratory Imaging.

RESPIRATORY

COPD

CHF5993

CCD-05993AA3-03

2

Completed

 A Randomized, Double-Blind, Placebo and Active-Controlled, incomplete Block Cross-Over, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 1531 pMDI (Formoterol Fumarate) in Asthmatic Subjects.

RESPIRATORY

COPD

CHF5993

CCD-05993AA3-02

2

Completed

 A 6-Week, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 5259 pMDI (Glycopyrronium Bromide) in Subjects with Chronic Obstructive Pulmonary Disease (COPD).

RESPIRATORY

COPD

CHF5993

CCD-05993AA3-01

2

Completed

 An 8-Week, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CHF 718 pMDI (Beclomethasone Dipropionate) in Asthmatic Subjects.

RESPIRATORY

COPD

CHF5993

CCD-05993BA1-01

1

Completed

 Clinical Pharmacology Study to Evaluate the total Systemic Exposure and the Lung Availability of CHF 5993, Administered Via the Multi-Dose Reservoir NEXThaler® Dry Powder Inhaler and Via A HFA-Pressurised Metered Dose Inhaler with and without Valved Holdi

RESPIRATORY

COPD

CHF5993

CCD-1101-PR-0056

1

Completed

 Open-Label, Randomized, Single-Dose, Placebo-Controlled, 4-Way Crossover Study to Investigate the Pharmacokinetic Interaction of Glycopyrrolate and Formoterol in Healthy Subjects. (TRIPLE 1)

RESPIRATORY

COPD

CHF5993

CCD-05993AA1-15

1

Completed

 Open Label, Uncontrolled, Non-Randomized, Single Dose, Scintigraphic Study to Investigate Lung Deposition of Inhaled 99mTc Radiolabelled CHF5993 pMDI in Healthy Volunteers, Asthmatic and COPD Patients.

RESPIRATORY

COPD

CHF5993

CCD-1208-PR-0090

3

Completed

 A 52-Wk Randomized Double Blind Parallel Trial: Combination of Beclometasone + Formoterol + Glycopyrrolate vs Tiotropium and vs Combination of Beclometasone + Formoterol and Tiotropium in Patients with Chronic Obstructive Pulmonary Disease.

RESPIRATORY

COPD

CHF5993

CCD-1207-PR-0091

3

Completed

 A Phase 3 Randomised Double Blind Randomised Parallel Multinational Trial Comparing a Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate to Foster® in Patients with Chronic Obstructive Pulmonary Disease.

RESPIRATORY

COPD

CHF5993

CCD-1107-PR-0067

2

Completed

 Randomized, Double-Blind, Active Controlled, 3-Arm Parallel Group, Multi-National, Multi-Centre Study to Evaluate the Cardiac Safety of Two Doses of CHF5993 b.i.d. Delivered via HFA pMDI Both Combined with CHF1535 b.i.d. Delivered via HFA pMDI versus CHF15

RESPIRATORY

COPD

CHF5993

CCD-05993AA1-14

3

Completed

 A 24-Week, Double Blind, Double Dummy, Randomized, Multinational, Multicentre, 2-Arm Parallel Group,Active Controlled Clinical Trial of Fixed Combination of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide Administered Via pM

RESPIRATORY

COPD

CHF5993

CCD-05993AA1-12

1

Completed

 Open-Label, Randomized, Single Dose, 2-Sequence, 2-Period Cross-Over Study to Investigate the Effect of inhibition of the Organic Cation Transport in the Kidneys by Cimetidine on the Pharmacokinetics of the CHF 5993 in Healthy Volunteers. (TRIPLE 12)

RESPIRATORY

COPD

CHF5993

CCD-05993AA1-10

1

Completed

 Open-Label, Non-Randomized, Parallel-Group Study to Investigate the Pharmacokinetics, Safety, and Tolerability of A Single Dose of CHF 5993 pMDI in Subjects with Mild, Moderate and Severe Renal Impairment in Comparison with Matched Healthy Control Subject.

RESPIRATORY

COPD

CHF5993

CCD-05993AA1-08

3

Completed

 52-Week, Double Blind, Randomized, 2 Active Parallel Arms Study of Fixed Combination CHF 5993 Administered vs Ultibro® in COPD Patients.

RESPIRATORY

COPD

CHF5993

CCD-05993AA1-04

1

Completed

 Open-Label, Randomized, 3-Way Cross-Over, Placebo Controlled, Single Dose Clinical Pharmacology Study in COPD Patients after Inhalation of CHF 5993 pMDI Using the Standard Actuator with or without Aerochamber Plus® Flow-Vu VHC Spacer. (TRIPLE 4)

RESPIRATORY

COPD

CHF5993

CCD-05993AA1-07

3

Completed

 A Multinational, Multicentre, Randomised, Open-Label, Active-Controlled, 26-Week, 2-Arm, Parallel Group Study to Evaluate the Non-inferiority of Fixed Combination of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide Administer

RESPIRATORY

COPD

CHF5993

CCD-0916-PR-0032

1/2

Completed

 Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Investigate the Bronchodilator Efficacy and Safety after Single and Repeated Administrations of Different Doses of Glycopyrrolate Via pMDI in Moderate to Severe COPD Patients (GLYCO 2).

RESPIRATORY

COPD

CHF5993

CCD-0915-PR-0031

1

Completed

 Pharmacokinetic, Randomized, Open-Label, Single-Dose, 3-Way Cross-Over Study of Intravenous and Inhaled Glycopyrrolate with or without Charcoal Block ingestion in Healthy Volunteers.

RESPIRATORY

COPD

CHF5993

CCD-1106-PR-0066

2

Completed

 A Randomized, Double-Blind, Active-Controlled, Cross-Over Study to Assess Efficacy and Safety of 3 Free Doses of Glycopyrrolate with Beclomethasone/Formoterol pMDI for the Treatment of COPD Patients.

RESPIRATORY

COPD

CHF5993

CCD-05993AA1-09

2

Completed

 A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled , 2-Way Crossover Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI (CHF 5259), for the Treatment of Patients with Chronic Obstructive Pulmon

RESPIRATORY

COPD

CHF4226

US/PR/033009/001/05

2

Completed

 A Randomized, Controlled, 14-Treatment Day, Multicenter Study to Determine the Optimal Efficacious and Safe Dose of CHF 4226 in A Metered Dose Inhaler in Treating Patients with Chronic Obstructive Pulmonary Disease .

RESPIRATORY

COPD

CHF4226

CCD-0808-PR-0036

1

Completed

 A Randomized, Double Blind, Single Dose, Positive and Placebo Controlled, Crossover Study of the Effects of Inhaled Carmoterol, at the Proposed Therapeutic and SupraTherapeutic Doses, on the QTc intervals in Healthy Subjects.

RESPIRATORY

COPD

CHF4226

CCD-0706-PR-0026

2

Completed

 Evaluation of the Effect of 2 Weeks Treatment with CHF 4226 pMDI 2¼μg and 4¼μg, Given once Daily in the Morning, on 24-hour FEV1 in Patients with COPD.

RESPIRATORY

COPD

CHF4226

RA/PR/033009/004/04

2

Completed

 Evaluation of the 24-hour Trough FEV1 Following 7 Days of Dosing with CHF4226 2μg once Daily. A Multicenter, Double-Blind, Double-Dummy, Randomised, Parallel Group, Placebo and Active (Formoterol 12μg b.i.d.) Controlled Study Followed by A 3-Week Ope

RESPIRATORY

COPD

CHF4226

CCD-0604-PR-0018

2

Completed

 Evaluation of the Effect of 4 Weeks Treatment with CHF 4226 pMDI 2μg Dose Given once Daily in the Evening on 24-hour Trough FEV1 in Adult and Adolescent Patients Aged 15 Years or Over with Moderate or Severe Persistant Asthma. A Multicenter, Double-Blin

RESPIRATORY

COPD

CHF1535

CCD-01535AC1-02

3

Completed

 A 24-Week, Double Blind, Double Dummy, Randomized, Multicentre, 2-Arm Parallel Group, Active Controlled Clinical Trial of Fixed Combination of Beclometasone Dipropionate Plus Formoterol Fumarate Administered via Pmdi (CHF 1535) versus the Fixed Combination

RESPIRATORY

COPD

CHF1535

CCD-0902-PR-0013

2

Completed

 A Single-Dose, Open-Label, 2-Way Cross-Over, Clinical Pharmacology Study of CHF 1535 50/6 HFA pMDI (Fixed Combination of Beclomethasone Dipropionate 50μg Plus Formoterol Fumarate 6 μg ) Using the Aerochamber Plus

RESPIRATORY

COPD

CHF1535

CCD-1007-PR-0045

3

Prematurely ended

 A 12-Week, Multicentre, Randomised, Double-Blind, Double-Dummy, 2-Arm Parallel Group Study Comparing the Efficacy and Safety of Foster® 100/6 (Beclomethasone Dipropionate 100 μg Plus Formoterol 6 μg/Actuation), 2 Puffs b.i.d., versus Symbicort® 200

RESPIRATORY

COPD

CHF1535

CCD-0910-PR-0021

3

Completed

 A 12-Week, Multicentre, Multinational, Randomized, Double-Blind, Double-Dummy, 2-Arm Parallel Group Study Comparing the Efficacy and Safety of Foster® 100/6 (Beclomethasone Dipropionate 100 μg Plus Formoterol 6 μg/Actuation), 2 Puffs b.i.d., versus

RESPIRATORY

COPD

CHF1535

CCD-0906-PR-0016

3

Completed

 A 48-Week, Double Blind, Randomized, Multinational, Multicentre, "Fixed Combination" Beclomethasone Dipropionate Plus Formoterol Fumarate versus Formoterol in Patients with Severe Chronic Obstructive Pulmonary Disease.

RESPIRATORY

COPD

CHF1535

CCD-01535AC1-01

Observational

Completed

 Assessment of Small Airways Involvement in Asthma (ATLANTIS); Multinational, Multicentre, Non-Pharmacological intervention, Cross-Sectional and Longitudinal Study.

RESPIRATORY

COPD

CHF1535

CCD-01535BC1-02

2

Completed

 A Phase II, Partial-Blind, Randomized, Placebo-Controlled, 5-Way Cross-Over Clinical Pharmacology Study To Evaluate The Pharmacodynamics Of BDP/B17MP And Formoterol Across Two Different Dose Levels Of CHF 1535 NEXThaler® DPI And CHF 1535 pMDI (Both Fixed

RESPIRATORY

COPD

CHF1535

CCD-01535BC1-01

2

Completed

 An Open Label Placebo Study to Assess the Inhalation Profile Obtained by Acoustic Monitoring in COPD Patients Using the NEXThaler® Dry Powder Inhaler (DPI) Device.

RESPIRATORY

Asthma and COPD

CHF6366

CCD-06366AA1-01

1/2

Completed

 A First in Human Randomised, Double-Blind, Placebo-Controlled Study of Single Ascending Doses in Healthy Male Volunteers and Repeated Ascending Dose in Asthmatic Patients Followed by A 3-Way Cross-Over, Placebo-Controlled, Single-Dose in COPD Patients to I

RESPIRATORY

Asthma and COPD

CHF5188

RA/PR/033012/002/05

2

Completed

 Evaluation of the Efficacy, Safety and Tolerability of the Concurrent Administration of CHF 4226 HFA pMDI and Extrafine Budesonide HFA pMDI, both Given once or Twice Daily (2μg + 200¼μg qd or 1¼μg + 100¼μg b.i.d.) Over an 8-Week Random

RESPIRATORY

Asthma and COPD

CHF5188

CCD-0803-PR-0031

2

Completed

 A Single Centre, Randomised, Double-Blind, Double-Dummy, Placebo-and Active-Controlled, 3-Way Cross-Over Study to Evaluate the 24 Hour FEV1 Profile of a Single Dose of CHF 5188 pMDI (400/4 mcg QD) (Fixed Combination Budesonide/Carmoterol 200/2 mcg) in Adul

RESPIRATORY

Asthma and COPD

CHF5188

CCD-0701-PR-0020

2

Completed

 Evaluation of Cardiac Safety, Tolerability and Efficacy of Cumulative Doses of CHF5188 pMDI (Fixed Combination Budesonide/Carmoterol 200/1 μg) Compared to Same Cumulative Doses of Carmoterol pMDI and Placebo in Asthmatic Patients a Monocenter, Randomise

RESPIRATORY

Asthma and COPD

CHF5188

CCD-0909-PR-0020

2

Completed

 A Randomised, Double-Blind, Active-Controlled, 3 Way Cross-Over Study to Evaluate the Effect on Trough FEV1 after 4 Weeks Treatment with CHF 5188 pMDI QD (Fixed Combination Budesonide / Carmoterol) in Adult Patients with Moderate or Severe Persistent Asthm

RESPIRATORY

Asthma and COPD

CHF1535

CCD-01535BA0-02

1

Completed

 A Randomized, Open Label, Parallel Group, Single Dose Study to Evaluate the Pharmacokinetics of Different Dosage of Foster NEXThaler® (Beclomethasone Dipropionate and Formoterol Inhalation Powder [100/6 mg]) in Healthy Chinese Subjects.

RESPIRATORY

Asthma and COPD

CHF1531

IMR2005-007

2

Completed

 In-Vivo Deposition of Formoterol after Inhalation of a Single Dose of Formoterol HFA- MDI (Chiesi), and Foradil P Inhalation Powder (Novartis) in COPD Patients.

RESPIRATORY

Asthma and COPD

CHF1531

RA/PR/3301/011/04

3

Completed

 A 3-Month, Double-Blind, Double-Dummy, Randomised, Multinational, Multicenter, 2-Arm Parallel-Group Study Comparing the Efficacy and Safety of Formoterol-HFA pMDI 12μg Twice Daily and Formoterol-DPI 12μg Twice Daily, in Patients with Stable Chronic O

RESPIRATORY

Asthma and COPD

CHF1531

RA/PR/3301/010/03

3

Completed

 A Three-Month, Double-Blind, Double Dummy, Parallel Group, Controlled Study Comparing the Efficacy and Safety between 12 μg Twice Daily of Formoterol-HFA and 12 μg Twice Daily of Formoterol-DPI (Foradil/Aerolizer) in Children with Persistent Asthma.

RESPIRATORY

Asthma and COPD

CHF1531

DM/PR/3301/003/05

2

Completed

 A Single Dose, Randomised, Double Blind, Double Dummy, Placebo-Controlled, Three-Period Crossover Clinical Study, Comparing the Efficacy, Safety and Tolerability of Formoterol-HFA pMDI 12 microgram per Actuation Administered by Means of a

RESPIRATORY

Asthma and COPD

CHF1531

CCD-0901-PR-0012

4

Completed

 A Single-Centre, Double-Blind, Double-Dummy, Randomised, Crossover Study to Investigate the Effect of Formoterol HFA-pMDI versus Salmeterol HFA-pMDI on Small Airways Physiological Parameters in COPD Patients.

RESPIRATORY

Asthma

CHF1535

MC/PR/033011/002/03

3

Completed

 Double Blind, Double Dummy, Multinational, Multicentre, Parallel-Group Design Clinical Trial of the Efficacy and Tolerability of CHF 1535 (Beclomethasone Dipropionate 100 μg + Formoterol 6 μg) pMDI via HFA-134a vs Budesonide 160 μg + Formoterol 4,

RESPIRATORY

Asthma

CHF1535

MC/PR/033011/001/03

3

Completed

 Double Blind, Multinational, Multicentre, Parallel-Group Design Clinical Trial of the Efficacy and Tolerability of CHF 1535 (Beclomethasone Dipropionate 100 μg + Formoterol 6 μg) pMDI via HFA-134A vs Fluticasone 125 μg + Salmeterol 25 μg pMDI (

RESPIRATORY

Asthma

CHF1530

MC/PR/1404/002/05

3

Completed

 Double Blind, Multinational, Multicentre, Parallel-Group, Placebo-Controlled Design Trial of the Efficacy and Safety of Nebulised Beclometahsone Dipropionate (400 1/4μg b.i.d.) plus as Needed Salbutamol versus as Needed Salbutamol or as Needed Salbutamo

RESPIRATORY

Asthma

CHF1530 HFA

MC/PR/033004/002/06

3

Completed

 Multicentre, Multinational, Randomised, Double Blind, Double Dummy, Active Drug Controlled, Parallel Group Study Design Clinical Trial of the Efficacy and Tolerability of Beclomethasone Dipropionate 250 mcg Plus Salbutamol 100 mcg in HFA pMDI Fixed Combina

RESPIRATORY

Asthma

CHF1535

MC/PR/033011/005/06

3

Completed

 Prospective, Randomised, Open-Label, Multicentre, Active Drug Controlled, Parallel Group Design Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate 400 mcg + Formoterol 24 mcg pMDI via HFA-134a (Foster

RESPIRATORY

Asthma

CHF4226 HFA

FB/PS/14/160/06

2

Completed

 Single Blind, Randomized, Crossover, Repeated Dose, Pharmacokinetic and Pharmacodynamic Interaction Study of CHF 4226 HFA and Extra-Fine BUD HFA in Asthmatic Patients.

RESPIRATORY

Asthma

CHF1530

MC/PR/1401/001/01

3

Completed

 Multinational, Double Blind, Randomised, Parallel Group Study on the Therapeutic Efficacy and Safety of Beclomethasone Dipropionate 250 mg Combined with Salbutamol 100 mg in the Treatment of Patients with Mild Persistent Asthma.

RESPIRATORY

Asthma

CHF1535

MC/PR/033011/004/05

3

Completed

 Double Blind, Double Dummy, Randomised, Parallel Group, Monocentric Clinical Trial on the Effects of CHF 1535 MDI or Seretide DPI on Biological and Functional Markers of Small Airways in Patients with Asthma: A Pilot Study.

RESPIRATORY

Asthma

CHF1535

RA/PR/033011/005/04

3

Completed

 A 12-Week Phase III Study to Evaluate the Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients with Mild to Moderate Persistent Asthma.

RESPIRATORY

Asthma

CHF1535

DM/PR/033011/003/03

3

Completed

 A 24-Week Phase III Study to Evaluate the Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients with Moderate to Severe Persistent Asthma.

RESPIRATORY

Asthma

CHF1535

DFIDM-1101

Observational

Completed

 International Cross-Sectional and Longitudinal Assessment on Asthma Control. (LIAISON)

RESPIRATORY

Asthma

CHF1535

MC/PR/15009/001/11

3

Completed

 A 12-Week, Multicenter, Randomized, Double-Blind, Double-Dummy, 2-Arm Parallel Group Study Comparing the Efficacy and Safety of Foster® NEXThaler® (Beclomethasone Dipropionate 100 μg Plus Formoterol 6 μg/Actuation), 2 Inhalations b.i.d., vers

RESPIRATORY

Asthma

CHF6001

CCD-1202-PR-0080

2

Completed

 A Randomised, Double-Blind, Placebo-Controlled, Three-Way Crossover Study to Evaluate the Efficacy after Allergen Challenge, Safety and Tolerability of Two Doses of Inhaled CHF6001 DPI after 9 Days of Treatment in Adult Patients with Asthma.

RESPIRATORY

Asthma

CHF5993

CCD-05993AB2-02

3

Completed

 A 52 Week, Randomized, Double Blind, Multinational, Multicentre, Active Controlled, 3-Arm Parallel Group Trial Comparing CHF 5993 200/6/12.5 μg pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Br

RESPIRATORY

Asthma

CHF5993

CCD-05993AB2-01

1

Completed

 Cross-Over Clinical Pharmacology Study, to Evaluate the Total Systemic Exposure and Lung Bioavailability of CHF 5993 pMDI Combination Across Two Different Dose Strengths, Administered with and without Activated Charcoal, in Healthy Volunteers.

RESPIRATORY

Asthma

CHF5993

CCD-1206-PR-0088

2

Completed

 A Multicentre, Randomised, Double-Blind, Active-Controlled, 3-Way Cross-Over Study to Evaluate the Efficacy and Safety of a Free Combination of 3 Doses of CHF 5259 (Glycopyrrolate) plus Foster® 100/6μg (Fixed Combination of Beclomethasone Dipropionate pl

RESPIRATORY

Asthma

CHF5993

CCD-05993AB1-03

3

Completed

 A 52 Week, Randomized, Double Blind, Multinational, Multicentre, Active Controlled, 2-Arm Parallel Group Trial Comparing CHF 5993 100/6/12.5 μg pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium

RESPIRATORY

Asthma

CHF5993

CCD-05993AB1-02

2

Completed

 A Multicentre, Randomised, Double-Blind, Placebo-Controlled, 2-Way Cross-Over Study to Evaluate the Efficacy and Safety of CHF 5259 (Glycopyrrolate Bromide) pMDI on top of QVAR® pMDI for the Treatment of Patients with Uncontrolled Asthma on Low-Medium Dos

RESPIRATORY

Asthma

CHF1535

FB/PS/14/165/06

1/2

Completed

 In-Vivo Deposition Measurement of Formoterol and Beclomethasone after Inhalation of A Single Dose of the Combination Formoterol Plus BDP HFA pMDI (Foster®, Chiesi) in Healthy Volunteers, Asthmatic and COPD Patients.

RESPIRATORY

Asthma

CHF1535

CCD-0605-PR-0021

3

Completed

 A 24-Week, Multicenter, Multinational, Randomized, Double-Blind, Triple-Dummy, 3-Arm Parallel Group Study Comparing the Efficacy and Safety of CHF 1535 200/6 (Beclomethasone Dipropionate 200 1/4μg Plus Formoterol 6 1/4μg/Actuation), 2 Puffs b.i.d., v

RESPIRATORY

Asthma

CHF1535

CCD-1005-PR-0040

3

Completed

 A 12-Week, Multinational, Multicentre, Randomised, Double-Blind, Double-Dummy, 2-Arm Parallel Group Study Comparing the Efficacy and Safety of CHF 1535 200/6μg versus Beclomethasone Dipropionate in Adult Asthmatic Patients not Adequately Controlled on H

RESPIRATORY

Asthma

CHF1535

CCD-0606-PR-0019

3

Completed

 A 12-Week, Multicenter, Multinational, Randomised, Double Blind, Double-Dummy (Open Label for the Spacer Group), 3-Arm Parallel Group Study Comparing the Efficacy and the Safety of CHF 1535 HFA pMDI (BDP/FF 100/6 μg Per Actuation) 2 Puffs Bid versus BDP

RESPIRATORY

Asthma

CHF1535

CCD-1104-PR-0062

2

Completed

 A Single-Dose, Open Label, Randomized, 3-Way Crossover, Clinical Pharmacology Study of CHF 1535 100/6 pMDI (Fixed Combination of Beclomethasone Dipropionate 100 μg Plus Formoterol Fumarate 6 μg) with or without Spacer Device versus the Free Combinati

RESPIRATORY

Asthma

CHF1535

CCD-0807-PR-0024

3

Completed

 A Phase III, 12-Week, Multicentre, Multinational, Randomised, Double-Blind, Double-Dummy, 3 Arm-Parallel Group Study to Test the Efficacy of CHF 1535 50/6 Microgram (Fixed Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate) versus A Free C

RESPIRATORY

Asthma

CHF1535

CCD-1012-PR-0051

3

Completed

 A Single Centre, Randomised, Double-Blind, Double-Dummy, 2-Way Cross Over Study to Compare Safety Assessed by Knemometry and Urinary Cortisol Measurements of CHF1535 50/6 pMDI (Fixed Combination of Beclomethasone Dipropionate and Formoterol Fumarate) and t

RESPIRATORY

Asthma

CHF1535

CCD-0903-PR-0060

2

Completed

 A Phase II, Multinational, Multicentre, Double Blind, Double Dummy, Randomised, Cross-Over, Active - and Placebo-Controlled Clinical Study to Compare the Bronchodilator Effect of Single Administration of CHF 1535 pMDI (Fixed Combination of Extrafine Beclom

RESPIRATORY

Asthma

CHF1535

CCD-1205-PR-0087

2

Completed

 A Phase II, Monocentric, Open, Randomized, 6-Way Cross-Over Clinical Pharmacology Study to Evaluate the Lung Bioavailability of BDP/B17MP and Formoterol and the Total Systemic Exposure Across Two Different Strengths of CHF 1535 NEXThaler Dry Powder Inhaler

RESPIRATORY

Asthma

CHF1535

CCD-1110-PR-0071

3

Withdrawn

 A Single Centre, Randomised, Double-Blind, Double-Dummy, 2-Way Cross Over Study to Compare Safety Assessed by Knemometry and Urinary Cortisol Measurements of CHF1535 50/6 NEXThaler® (Fixed Combination of Beclomethasone Dipropionate and Formoterol Fumar

RESPIRATORY

Asthma

CHF1535

CCD-1103-PR-0058

2

Completed

  A Single-Dose, Open-Label, Randomized, 2-Way Cross-Over, Clinical Pharmacology Study of CHF 1535 50/6 NEXT DPI® (Fixed Combination of Beclometasone Dipropionate 50 μg Plus Formoterol Fumarate 6 μg ) versus the Free Combination of Licensed Beclometa

RESPIRATORY

Asthma

CHF1535

CCD-01535BB1-01

2

Completed

 A Single-Dose, Open-Label, Randomized, 2-Way Cross-Over Study of CHF 1535 35/4 NEXThaler® (Fixed Combination of Beclometasone Dipropionate (BDP) 35 1/4μg Plus Formoterol Fumarate (FF) 4 1/4μg versus the Free Combination of Licensed BDP DPI (Dry Powd

RESPIRATORY

Asthma

CHF1535

CCD-0705-PR-0027

3

Completed

 A 12-Week, Multinational, Randomised, Double Blind, Double Dummy, 4-Arm Parallel-Group Study Comparing the Efficacy and Safety of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate) 100 + 6 1/4μg/Actuation Inhalation Powder

RESPIRATORY

Asthma

CHF1535

CCD-0809-PR-0038

2

Completed

 A Phase II, Multinational, Multicentre, Double Blind, Double Dummy, Randomised, 5-Way Cross-Over, Placebo and Active Controlled Clinical Study to Test the Non-inferiority of a Single Dose of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate 100 ÃŽ

RESPIRATORY

Asthma

CHF1535

CCD-0815-PR-0011

1/2

Completed

 In-Vivo Deposition Measurement of Beclometasone and Formoterol after Inhalation of a Single Dose of the Combination BDP Plus Formoterol NEXT (TM) DPI in Healthy Volunteers, Asthmatic and COPD Patients.

RESPIRATORY

Asthma

CHF1535

CCD-1009-PR-0050

3

Completed

 A Phase 3, 8-Week Clinical Trial to Test the Efficacy of CHF1535 Via NEXT DPI® versus Same Dose of CHF1535 pMDI and Beclomethasone DPI 100μg on PEF in Adult Asthmatic Patients after 1 Month of Treatment with Foster.

RESPIRATORY

Asthma

CHF1535

CCD-1113-PR-0074

2

Completed

 An Open Label Placebo Study to Assess the Inhalation Profile Obtained by Acoustic Monitoring in Asthmatic Patients Using the NEXThaler Dry Powder Inhaler (DPI) Device.

RESPIRATORY

Asthma

CHF1535

CCD-1017-PR-0034

2

Completed

 A Multicenter, Multinational, Single-Dose, Open Label, Randomized, 2-Way Crossover, Clinical Pharmacology Study of CHF 1535 100/6 NEXT DPI® (Fixed Combination of Beclomethasone Dipropionate 100 μg Plus Formoterol Fumarate 6 μg) versus the Free Combi

RESPIRATORY

Asthma

CHF1535

CCD-1015-PR-0055

2

Completed

 A Single-Dose, Open-Label, Randomised, 2-Way Crossover, Clinical Pharmacology Study of Four Inhalations of CHF 1535 100/6 NEXT DPI® (Fixed Combination of Beclomethasone Diproponate 100 μg Plus Formoterol Fumarate 6 μg) versus the Same Dose of CHF 15

RESPIRATORY

Asthma

CHF1535

CCD-01535BD1-01

2

Completed

 A Single Dose, Randomised, Double Blind, Double Dummy, Placebo Controlled, 3-Way Crossover Clinical Study, Comparing the Onset of Relief from Methacholine-Induced Bronchoconstriction with CHF1535 100/6 μg NEXThaler® versus CHF1535 100/6 μg pMDI in Asthm

RESPIRATORY

Asthma

CHF1535

CCD-01535BA0-01

3

Completed

 A 12-Week, Multicenter, Randomized, Double-Blind, Double-Dummy, 2-Arm Parallel Group Study Comparing the Efficacy and Safety of Foster 100/6mg NEXThaler, 2 Inhalations b.i.d., versus Foster 100/6mg pMDI, 2 Puffs b.i.d. in Patients with Controlled Asthma.

RESPIRATORY

Asthma

CHF1535

CCD-0804-PR-0034

3

Completed

 48-Week, Multinational, Randomized, Double-Blind, 2-Parallel Groups, Comparing the Efficacy of Foster for Maintenance and Reliever versus Fixed-Dose Foster for Maintenance plus Salbutamol as Reliever in Asthmatics >=18 Years of Age.

RESPIRATORY

Asthma

CHF1535

CCD-0806-PR-0032

4

Completed

 A Phase 4, Multinational, Multicentre, Double Blind, Double Dummy, Randomized, Parallel Group, Controlled Clinical Study of Fixed Combination Beclomethasone Dipropionate 100 μg Plus Formoterol Fumarate 6 μg pMDI with HFA-134a Propellant (CHF1535, Fos

RESPIRATORY

Asthma

CHF1535

DM/PR/033011/005/05

3

Completed

 A 48-Week, Double Blind, Double Dummy, Randomised, Multinational, Multicentre, 3-Arm Parallel Group Clinical Study of Fixed Combination Beclomethasone Dipropionate plus Formoterol Fumarate Administered via pMDI with HFA-134a Propellant (CHF 1535) versus Fi

RESPIRATORY

Asthma

CHF1535

FB/PS/14/169/07

2

Completed

 Dose Response Evaluation of CHF 1535 HFA pMDI in Asthmatic Patients Using Lung Function, Adenosine Monophosphate Bronchial Challenge and Fractional Exhaled Nitric Oxide (FENO).

RESPIRATORY

Asthma

CHF1535

CCD-0802-PR-0029

2

Completed

 A Single Dose, Randomized, Double Blind, Double Dummy, Placebo Controlled, Three-Period Crossover Clinical Study, Comparing the Onset of Relief from Methacholine Induced Bronchoconstriction with Fixed Combination Beclomethasone Dipropionate 100 μg plus

RESPIRATORY

Asthma

CHF1535

CCD-0812-PR-0003

4

Completed

 Effect of Beclomethasone Dipropionate/Formoterol Fumarate (BPD+FF) Administered As a Fixed pMDI Combination on Lung Impedance and Exhaled Nitric Oxide in Comparison with the Fixed Combination of Budesonide and Formoterol Fumarate (Symbicort Turbohaler®).

RESPIRATORY

Asthma

CHF1535

CCD-01535BA1-01

2

Completed

 A Phase II, Multicentre, Double Blind, Randomised, 5-Way Cross-Over Study to Test the Non-Inferiority of the Acute Bronchodilator Effect of CHF 1535 200/6 μg NEXThaler® versus CHF 1535 100/6 μg NEXThaler® in Partially Controlled and Uncontrolled Ad

RESPIRATORY

Asthma

CHF718

CCD-0704-PR-0024

3

Completed

 A Single Centre Double-Blind, Randomised 3 Period Cross Over Study to Compare Safety Assessed by Knemometry and Urinary Cortisol Measurements of Beclomethasone Dipropionate HFA pMDI 100 and 200 μg b.i.d. Using Aerochamber Plus"! Spacing Device and Beclo

RESPIRATORY

Asthma

CHF718

CCD-1008-PR-0049

2

Completed

 Pilot, Open-Label, Randomized, Repeated Dose, 4-Way Cross-Over, Clinical Pharmacology Study of Beclomethasone Dipropionate (Clenil® Modulite®) 250 μg HFA pMDI Using the Aerochamber Plus

RESPIRATORY

Acute Rhinosinusitis

CHF718

MC/PR/1400/007/11

3

Completed

 Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study on the Therapeutic Efficacy and Safety of Beclomethasone Dipropionate Suspension for Inhalation 800 micrograms Twice Daily vs Placebo Added to Antibiotic Therapy in Patients wi

RESPIRATORY

None

CHF1535

FB/PS/14/163/06

1

Completed

 Pharmacokinetics and Lung Bioavailability of BDP/Formoterol HFA Fixed Combination after Single Administration in 12 Healthy Volunteers Using the Standard Actuator with or without Charcoal Block or the Aerochamber Spacer.

RARE DISEASES

Alpha-mannosidosis

CHFLMZYM

CCD-LMZYMAA1-10 - rhLAMAN-10

3

Completed

 A Single Center, Open Label Clinical Trial investigating the Long-Term Efficacy of rhLAMAN (Recombinant Human Alpha-Mannosidase or Lamazym) Treatment in Subjects with Alpha-Mannosidosis Who Previously Participated in Lamazym Trials.

RARE DISEASES

Alpha-mannosidosis

CHFLMZYM

CCD-LMZYMAA1-09 - rhLAMAN-09

3

Completed

 A Multi-Center, Un-Controlled, Open-Labeled Trial of the Long-Term Safety of Velmanase Alfa aftercare Treatment of Subjects with Alpha-Mannosidosis Whom Previously Participated in Velmanase Alfa - Trials.

RARE DISEASES

Alpha-mannosidosis

CHFLMZYM

CCD-LMZYMAA1-08 - rhLAMAN-08

2

Completed

 A 24-Month Multicenter, Open-Label Phase II Trial investigating the Safety and Efficacy of Repeated Velmanase Alfa (Recombinant Human Alpha-Mannosidase) Treatment in Pediatric Patients Below 6 Years of Age with Alpha-Mannosidosis.

RARE DISEASES

Alpha-mannosidosis

CHFLMZYM

CCD-LMZYMAA1-07 - rhLAMAN-07

3

Completed

 A Multi-Center, Un-Controlled, Open-Labeled Trial of the Long-Term Safety of Lamazym aftercare Treatment of Subjects with Alpha-Mannosidosis Who Previously Participated in Lamazym-Trials.

RARE DISEASES

Alpha-mannosidosis

CHFLMZYM

CCD-LMZYMAA1-05 - rhLAMAN-05

3

Completed

 A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Trial, investigating the Efficacy and Safety of Repeated Lamazym Treatment of Subjects with Alpha-Mannosidosis.

RARE DISEASES

Alpha-mannosidosis

CHFLMZYM

CCD-LMZYMAA1-04 - rhLAMAN-04

2

Completed

 A Multi-Center, Open-Label Trial of the Long-Term Efficacy and Safety of Lamazym for the Treatment of Patients with Alpha-Mannosidosis.

RARE DISEASES

Alpha-mannosidosis

CHFLMZYM

CCD-LMZYMAA1-03 - rhLAMAN-03

2

Completed

 A Single Center, Randomized, Open-Label, Multiple-Dose Study of the Efficacy and Long-Term Safety of rhLAMAN (Recombinant Human Alpha-Mannosidase or Lamazym) for the Treatment of Patients with Alpha-Mannosidosis.

RARE DISEASES

Alpha-mannosidosis

CHFLMZYM

CCD-LMZYMAA1-02 - rhLAMAN-02

1

Completed

 A Single Center, Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of rhLAMAN (Recombinant Human Alpha-Mannosidase or Lamazym) for the Treatment of Patients with Alpha-Mannosidosis.

RARE DISEASES

Alpha-mannosidosis

CHFLMZYM

CCD-LMZYMAA1-01 - rhLAMAN-01

Observational

Completed

 The Natural History of Alpha-Mannosidosis.

OTHERS

Postmenopausal Osteoporosis

CHF0257

MC/PR/9900/004/10

3

Completed

 Multicentre, Randomized, Open-Label, Two-Arm Parallel Groups, Active Controlled Study Design to Demonstrate Efficacy and Tolerability of Clodronate 200 mg/4 mL Solution for Intramuscular Use with 1% Lidocaine Every Other Week vs Clodronate 100 mg/3,3mL Sol

OTHERS

Mild or Moderate Ulcerative Colitis

CHF1514

CMA-0402-PR-0005

3

Completed

 Efficacy and Safety of Beclomethasone Dipropionate Gastro-Resistant, Prolonged Release Tablets (CHF 1514) Compared with oral Prednisone, in a 8-Week Treatment Period, in Patients with Active Ulcerative Colitis. An international, Muticentre, Randomised, Dou

OTHERS

Hypertension

CHF1533

CMA-0633-PR-0012

3/4

Completed

 Double Blind, Randomised, Parallel Group, Multicentre Study to Evaluate the Effects of Manidipine 20 mg vs Amlodipine 10 mg and the Combination of Manidipine 10 mg Plus Delapril 30 mg vs Amlodipine 5 mg Plus Delapril 30 mg on intraglomerular Pressure in Hy

OTHERS

Hypertension

CHF1532

CMA-0601-PR-0004

4

Completed

 A Twelve-Week, Multicentre, Double Blind, Randomised, Parallel Group, Clinical Study to Assess the Antihypertensive Efficacy of Delapril 15 mg b.i.d. and 30 mg b.i.d. versus Lisinopril and Placebo.

OTHERS

Hypertension

CHF1521

DM/PR/7401/009/03

3

Completed

 Double Blind, Randomised, Parallel Group, Multicentre Study to Evaluate the Efficacy and Tolerability of CHF 1521 (Fixed Combination of Manidipine and Delapril) vs Losartan 50 mg and Hydrochlorothiazide 12.5 mg in Type 2 Diabetic Hypertensive Patients. The

OTHERS

Crohn's ileitis

CHF1514

MC/PR/1405/002/02

3

Completed

  A Randomised, Controlled with Placebo, Double Blind, Double Dummy, Parallel Group Study on the Therapeutic Efficacy and Safety of Beclomethasone Dipropionate (BDP) in the Treatment of Patients with Post-Active Crohn's Ileitis with Remission induced by A C

NEONATOLOGY

Respiratory Distress Syndrome (RDS)

CHF5633

CCD-1011-PR-0059

1

Completed

 A First in Human Clinical Study on the Safety and Tolerability of Two Escalating Single Doses of CHF 5633 (Synthetic Surfactant) in Preterm Neonates with Respiratory Distress Syndrome.

NEONATOLOGY

Respiratory Distress Syndrome (RDS)

CHF5633

CCD-05633AA1-02

2

Completed

 A Double Blind, Randomized, Controlled Study to Investigate the Efficacy and Safety of Synthetic Surfactant (CHF 5633) in Comparison to Porcine Surfactant (Poractant Alfa, Curosurf®) in the Treatment of Preterm Neonates with Respiratory Distress Syndrome.

NEONATOLOGY

Respiratory Distress Syndrome (RDS)

CHF1534

CCD-01534CA1-01

2

Prematurely ended

 A Randomized, Open, Multinational, Multicentre,2-Part Study in Spontaneously Breathing Preterm Neonates with Mild to Moderate Respiratory Distress Syndrome (RDS) to Investigate the Safety, Tolerability and Efficacy of Inhaled Nebulised Poractant Alfa (Porc

NEONATOLOGY

Respiratory Distress Syndrome (RDS)

CHF1534

CCD-050000-01

3

Prematurely ended

 A Randomized, Controlled Study in Preterm Neonates with RDS to Compare Two Procedures for Porcine Surfactant (Poractant Alfa, Curosurf®) Administration: a Less invasive Method (LISA) and the Conventional Administration.

NEONATOLOGY

Respiratory Distress Syndrome (RDS)

CHF1534

DM/PR/5000/004/05

3

Prematurely ended

  A Randomized Controlled Study to Evaluate the Efficacy of a Supplemental Dose of Curosurf in Pre-Term infants on Mechanical Ventilation for Respiratory Distress Syndrome (RDS) in Preventing Extubation Failure.

NEONATOLOGY

Respiratory Distress Syndrome (RDS)

CHF1534

DM/PR/5000/003/05

2

Completed

 A Randomized Controlled Pilot Study for the Comparison of Efficacy of Bronchoalveolar Lavage (BAL) with Curosurf® in A Dosage 50 mg/kg vs Not Treated Control in Adult Patients Affected by Pulmonary Contusion from Chest Trauma at Risk of ALI/ARDS Using Low

NEONATOLOGY

Respiratory Distress Syndrome (RDS)

CHF1534

DM/PR/5000/002/04

4

Completed

 An international, Open, Randomized, Controlled Study to Evaluate the Efficacy of Combining Prophylactic Curosurf® with Early Nasal CPAP versus Early Nasal CPAP Alone in Very Preterm infants at Risk of Respiratory Distress Syndrome.