Chiesi Farmaceutici S.p.A.: Asthma trials

The registry lists 70 Asthma studies with Chiesi Farmaceutici S.p.A. as lead sponsor. 11 are open to participants now and 13 have results posted.

Phase 1 2Phase 2 23Phase 3 25Phase 4 5No phase 16(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.

• Safety and Efficacy Comparison Between CHF5993 100/6 12.5µg pMDI to Seretide Evohaler 125/25µg pMDI in Adolescent Subjects With AsthmaNot yet recruitingNCT07858123Phase 3
• Evaluation of Safety, Side Effects, and How the Drug, Inhaled CHF10136, Is Absorbed, Modified and Removed From the Body in Healthy Adults and Adults With AsthmaRecruitingNCT07851623Phase 1
• BETRI-Prospective: Asthma Control in Single Inhaler ICS/LABA/LAMA (87/5/9 pMDI [BDP/FF/GB - 100/6/12.5 μg]) vs Single Inhaler ICS/LABA (200/6 pMDI [BDP/FF - 200/6 μg])RecruitingNCT07666490Phase 4
• 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-agonistsRecruitingNCT07546981Phase 3
• Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH)RecruitingNCT07489911
• Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate AsthmaRecruitingNCT07301736Phase 2
• Efficacy of a Smart add-on Device in Combination With a Triple Treatment in Asthma Patients on Inhaler Technique and AdherenceRecruitingNCT06908421
• The Importance of Tailored Education And Device Handling for Asthmatic PatientsNot yet recruitingNCT06840522
• Investigation of Fixed Triple Inhaled Combination in Asthmatic Patients, in a Real-life SettingRecruitingNCT06678191
• TriMaximize: A Multicentre, Prospective, Non-interventional Trial in Asthma PatientsRecruitingNCT06567977
• A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related OutcomesRecruitingNCT05728749
• A Study to Compare the Effects of Two Propellants in Adults With Mild AsthmaCompletedNCT05472662Phase 2Results posted
• 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 CorticosteroidCompletedNCT05292586Phase 3Results posted
• Study in Adult Patients With Moderate to Severe AsthmaCompletedNCT04886999Phase 3Results posted
• Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma.CompletedNCT03453112Phase 3Results posted
• A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)CompletedNCT03086460Phase 2Results posted
• An 8-week Dose Ranging Study of CHF 718 pMDI in Asthmatic SubjectsCompletedNCT03084718Phase 2Results posted
• TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)CompletedNCT02676089Phase 3Results posted
• TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABACompletedNCT02676076Phase 3Results posted
• Efficacy of LAMA Added to ICS in Treatment of Asthma (ELITRA)CompletedNCT02296411Phase 2Results posted
• Triple in Asthma Dose FindingCompletedNCT02127866Phase 2Results posted
• Single Dose Bronchodilatory Study in AsthmaCompletedNCT01805687Phase 4Results posted
• Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic PatientsCompletedNCT01577082Phase 3Results posted
• Study on Foster Efficacy Maintenance and Reliever vs Foster Maintenance + Salbutamol Reliever in Asthmatics (MART2)CompletedNCT00861926Phase 3Results posted
• A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate CHF 6001CompletedNCT06900816Phase 2
• Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life SettingCompletedNCT06786767
• Comparison Between CHF5993 pMDI 200/6/12.5 µg HFA-152a VS CHF5993 pMDI 200/6/12.5 µg HFA-134a in Subjects With Asthma (TRECOS).CompletedNCT06264674Phase 3
• Observational Study on Therapy Pathways of Asthamics Treated With ICS/LABA/LAMA Therapy in a Real-world SettingCompletedNCT06100042
• Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance TherapyTerminatedNCT06029595Phase 2
• Effects of Beclometasone Dipropionate/Formoterol Fumarate Via NEXT(Haler) in a Real-world Study on Asthma ControlCompletedNCT05168995
• Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABATerminatedNCT05018598Phase 4
• A Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extrafine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Out-comesCompletedNCT04902573
• Study on Patterns of Care in Mild Asthmatic PatientsCompletedNCT04598555
• Efficacy and Safety of CHF 6532 in Patients With Uncontrolled Severe Eosinophilic AsthmaTerminatedNCT04049175Phase 3
• Effect of the Use of an add-on Device Connected to a Smartphone App on Difficult-to-treat Asthmatic Patient's AdherenceCompletedNCT03951714Not applicable
• A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients.CompletedNCT03108534Phase 2
• Effect of OC000459 on Eosinophilic Airway Inflammation in Severe AsthmaCompletedNCT02560610Phase 2
• AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)CompletedNCT02123667
• Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years OldCompletedNCT01848769Phase 2
• Single-Dose Clinical Pharmacology Study in Asthmatic Adolescent and Adult PatientsCompletedNCT01803087Phase 2
• Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation PowderCompletedNCT01738087Phase 2
• A Study to Evaluate the Efficacy After Allergen Challenge, Safety and Tolerability of Inhaled CHF6001 DPI in AsthmaticsCompletedNCT01689571Phase 2
• Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic ChildrenWithdrawnNCT01658891Phase 3
• An Open Label Placebo Study to Assess the Inhalation Profile in Asthmatic Patients Using the Nexthaler® Dry Powder Inhaler (DPI) DeviceCompletedNCT01651650Phase 2
• Bronchodilator Effect of CHF1535 pMDI Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic ChildrenCompletedNCT01584492Phase 2
• Prevalence and Reversibility of Lung Hyperinflation in AsthmaCompletedNCT01573364
• A Study in Patients With AsthmaCompletedNCT01570478Phase 3
• International Cross-sectional and Longitudinal Assessment on Asthma Control (Liaison)CompletedNCT01567280
• Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic ChildrenCompletedNCT01475032Phase 3
• Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years OldCompletedNCT01468272Phase 2
• Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic ChildrenCompletedNCT01450774Phase 3
• Pilot Pharmacokinetic Clenil Study With AeroChamber Plus™ or Volumatic™ Spacer DevicesCompletedNCT01370031Phase 2
• Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic PatientsCompletedNCT01345916Phase 3
• A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients.CompletedNCT01191424Phase 2
• Prospective Study on Asthma ControlCompletedNCT01110460
• Cross-over Study to Evaluate the Effect on Trough Forced Expiratory Volume in One Second (FEV1) After 4 Weeks Treatment With CHF 5188 pMDI qd in Adult Patients With Persistent AsthmaCompletedNCT01070524Phase 2
• FACTO Study (Foster® As Complete Treatment Option)CompletedNCT00901368Phase 4
• Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic PatientsCompletedNCT00868023Phase 2
• A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe AsthmaCompletedNCT00862394Phase 3
• Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent AsthmaCompletedNCT00862264Phase 3
• Assessment of PFT, Safety, and PK of Zileuton Injection in Asthma PatientsCompletedNCT00534625Phase 2
• Efficacy and Tolerability of Beclomethasone Plus Salbutamol in HFA pMDI Fixed Combination vs Beclomethasone Plus Salbutamol in CFC pMDI Fixed Combination in a 12-week Treatment Period of Adult Patients With Uncontrolled AsthmaCompletedNCT00528723Phase 3
• Efficacy and Safety of Nebulised Beclomethasone Dipropionate Plus as Needed Salbutamol vs as Needed Salbutamol or as Needed Salbutamol/Beclomethasone Fixed Combination in Young Children With Asthma SymptomsCompletedNCT00497523Phase 3
• Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate Plus Formoterol vs Fluticasone Propionate Plus Salmeterol in the 6 Months Step Down Treatment of AsthmaCompletedNCT00497237Phase 3
• Zileuton CR vs Placebo in Poorly Controlled Asthma Patients on Moderate Dose ICSTerminatedNCT00486343Phase 4
• Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent AsthmaCompletedNCT00476268Phase 3
• Efficacy and Tolerability of Beclomethasone Dipropionate 100 µg + Formoterol 6 µg pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler®. (Symbicort®)CompletedNCT00413387Phase 3
• EFFICACY AND TOLERABILITY OF BECLOMETHASONE DIPROPIONATE 100 µg + FORMOTEROL 6 µg pMDI VIA HFA-134a vs. FLUTICASONE 125 µg + SALMETEROL 25 µg pMDICompletedNCT00394368Phase 3
• As Needed Beclomethasone/Salbutamol Combination in Single Inhaler for Mild Persistent AsthmaCompletedNCT00382889Phase 3
• Safety Study of Zileuton Injection in Patients With AsthmaCompletedNCT00299065Phase 1/2