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CHF1535 200/6 µg pMDI
CHF1535 is a fixed-dose combination of beclomethasone dipropionate (ICS) and formoterol (LABA) that reduces airway inflammation and improves bronchial smooth muscle relaxation.
CHF1535 is a fixed-dose combination of beclomethasone dipropionate (ICS) and formoterol (LABA) that reduces airway inflammation and improves bronchial smooth muscle relaxation. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | CHF1535 200/6 µg pMDI |
|---|---|
| Also known as | Beclometasone Dipropionate/Formoterol Fumarate (BPD/FF) |
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | ICS/LABA combination (Inhaled Corticosteroid/Long-Acting Beta-2 Agonist) |
| Target | Glucocorticoid receptor (beclomethasone); Beta-2 adrenergic receptor (formoterol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Beclomethasone dipropionate is an inhaled corticosteroid that suppresses airway inflammation by binding to glucocorticoid receptors, reducing cytokine production and immune cell infiltration. Formoterol is a long-acting beta-2 agonist that activates beta-2 adrenergic receptors on bronchial smooth muscle, causing bronchodilation. The combination provides both anti-inflammatory and bronchodilatory effects for sustained asthma and COPD control.
Approved indications
- Asthma maintenance 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 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)
- Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI) (PHASE2)
- Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD (PHASE3)
- TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER) (PHASE3)
- Clinical Pharmacology Study of CHF1535 pMDI 50/6 µg Versus The Free Combination In Asthmatic Children 5-11 Years Old (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 (PHASE3)
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 200/6 µg pMDI CI brief — competitive landscape report
- CHF1535 200/6 µg pMDI updates RSS · CI watch RSS
- Chiesi Farmaceutici S.p.A. portfolio CI