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
NCT05292586 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1377
Last updated 2025-09-04
Summary
Compare the superiority of CHF 1535 versus CHF 718 in subjects with asthma who are on medium or high dose inhaled corticosteroids.
Conditions
Interventions
- DRUG
-
Beclomethasone Dipropionate/Formoterol Fumarate
Available in pressurized inhalation solution BDP/FF 200/6 µg
- DRUG
-
Beclomethasone Dipropionate
Available in pressurized inhalation solution BDP 100 µg
Sponsors & Collaborators
-
Chiesi Farmaceutici S.p.A.
lead INDUSTRY
Principal Investigators
-
Steven F. Weinstein, M.D. · Allergy and Asthma Specialists Medical Group and Research Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-31
- Primary Completion
- 2024-06-24
- Completion
- 2024-06-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Bronchodilator Effect of CHF1535 pMDI Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children
NCT01584492 ·Status: COMPLETED ·Phase: PHASE2
-
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.
NCT01191424 ·Status: COMPLETED ·Phase: PHASE2
-
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 Asthma
NCT00862394 ·Status: COMPLETED ·Phase: PHASE3
-
Beclomethasone Dipropionate HFA in Adult and Adolescent Subjects With Mild to Moderate Persistent Asthma
NCT03835871 ·Status: WITHDRAWN ·Phase: PHASE3
-
TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA
NCT02676076 ·Status: COMPLETED ·Phase: PHASE3
-
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 Asthma
NCT00497237 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma
NCT02513160 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy Study of the Product "CHF 1535" Versus Beclomethasone (BDP) and Free Combo in Asthmatic Children
NCT01475032 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients
NCT01345916 ·Status: COMPLETED ·Phase: PHASE3
-
Beclomethasone Dipropionate HFA in Adult and Adolescent Subjects With Persistent Asthma
NCT03834012 ·Status: WITHDRAWN ·Phase: PHASE3
-
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 Asthma
NCT00528723 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old
NCT01848769 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children
NCT01450774 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old
NCT01468272 ·Status: COMPLETED ·Phase: PHASE2
-
Triple in Asthma Dose Finding
NCT02127866 ·Status: COMPLETED ·Phase: PHASE2
-
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma
NCT02031640 ·Status: COMPLETED ·Phase: PHASE3
-
Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
NCT07301736 ·Status: RECRUITING ·Phase: PHASE2
-
A BE Study to Compare Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg and QVAR® 40 mcg, Inhalation Aerosol
NCT03562949 ·Status: TERMINATED ·Phase: PHASE3
-
A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma
NCT02040779 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating Etanercept in Moderate to Severe Asthma
NCT00141791 ·Status: COMPLETED ·Phase: PHASE2
-
Extra-fine Formoterol/Beclomethasone in Asthmatic Crisis
NCT02345993 ·Status: UNKNOWN ·Phase: PHASE4
-
Next DPI LABA, Multicentre, 5-way Cross-over, Adult Asthmatic Patients
NCT00868023 ·Status: COMPLETED ·Phase: PHASE2
-
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®)
NCT00413387 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Safety of Foradil in Patients With Persistent Asthma
NCT01845025 ·Status: TERMINATED ·Phase: PHASE4
-
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 Asthma
NCT01070524 ·Status: COMPLETED ·Phase: PHASE2