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CHF1535
CHF1535 is a fixed-dose combination of beclomethasone dipropionate and formoterol fumarate that reduces airway inflammation and provides bronchodilation for respiratory disease management.
CHF1535 is a fixed-dose combination of beclomethasone dipropionate and formoterol fumarate that reduces airway inflammation and provides bronchodilation for respiratory disease management. Used for Asthma maintenance and reliever therapy, Chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | CHF1535 |
|---|---|
| Also known as | FOSTER®, Foster, Fostair |
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination |
| Target | Glucocorticoid receptor; beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | FDA-approved |
Mechanism of action
Beclomethasone dipropionate is an inhaled corticosteroid that suppresses airway inflammation by binding to glucocorticoid receptors, while formoterol fumarate is a long-acting beta-2 agonist that relaxes bronchial smooth muscle and provides sustained bronchodilation. Together, they provide complementary anti-inflammatory and bronchodilatory effects for maintenance and relief of respiratory symptoms.
Approved indications
- Asthma maintenance and reliever therapy
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness
Key clinical trials
- Study in Adult Patients With Moderate to Severe Asthma (PHASE3)
- Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients (PHASE3)
- 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 COPD (PHASE3)
- 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 (PHASE3)
- Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (PHASE3)
- Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABA (PHASE4)
- CHF5993 and CHF1535 pMDI on Lung Hyperinflation and Exercise Endurance Time in Subjects With COPD (PHASE4)
- A Phase II, 5-way Cross-over Study to Evaluate the Pharmacodynamics of "Nexthaler" Dry Powder Inhaler in COPD Patients (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CHF1535 CI brief — competitive landscape report
- CHF1535 updates RSS · CI watch RSS
- Chiesi Farmaceutici S.p.A. portfolio CI