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CHF 1535 200/6 µg
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 200/6 µg |
|---|---|
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA) |
| Target | Glucocorticoid receptor; beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
The formulation combines beclomethasone dipropionate (ICS) with formoterol fumarate (LABA). The corticosteroid component suppresses airway inflammation by binding glucocorticoid receptors, while formoterol activates beta-2 adrenergic receptors to produce sustained bronchodilation. This dual mechanism addresses both the inflammatory and obstructive components of chronic respiratory disease.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness
Key clinical trials
- 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)
- 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)
- Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old (PHASE2)
- Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients (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 200/6 µg CI brief — competitive landscape report
- CHF 1535 200/6 µg updates RSS · CI watch RSS
- Chiesi Farmaceutici S.p.A. portfolio CI