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CHF 1535 50/6µg
CHF 1535 is a fixed-dose combination inhaled corticosteroid and long-acting beta-2 agonist that reduces airway inflammation and improves bronchodilation in respiratory disease.
CHF 1535 is a fixed-dose combination inhaled corticosteroid and long-acting beta-2 agonist that reduces airway inflammation and improves bronchodilation in respiratory disease. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | CHF 1535 50/6µg |
|---|---|
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination |
| Target | Glucocorticoid receptor (GR); Beta-2 adrenergic receptor (β2AR) |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
The formulation combines beclomethasone dipropionate (ICS) at 50µg to suppress airway inflammation and formoterol (LABA) at 6µg to provide sustained bronchodilation. This dual mechanism addresses both the inflammatory and obstructive components of chronic respiratory conditions, improving airflow and reducing exacerbations.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness/anxiety
Key clinical trials
- Clinical Pharmacology of CHF 1535 50/6 ug Next DPI in Children 5-11 Years Old (PHASE2)
- Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children (PHASE3)
- Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children (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:
- CHF 1535 50/6µg CI brief — competitive landscape report
- CHF 1535 50/6µg updates RSS · CI watch RSS
- Chiesi Farmaceutici S.p.A. portfolio CI