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CHF 1535 100/6 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 100/6 µg |
|---|---|
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA) |
| Target | Glucocorticoid receptor (beclomethasone); beta-2 adrenergic receptor (formoterol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
The formulation combines beclomethasone dipropionate (ICS) with formoterol fumarate (LABA). Beclomethasone reduces airway inflammation by binding glucocorticoid receptors, while formoterol provides sustained bronchodilation through beta-2 adrenergic receptor agonism. 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/anxiety
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)
- Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (PHASE3)
- Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI) (PHASE2)
- Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD Patients (PHASE1, PHASE2)
- TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA (PHASE3)
- 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®) (PHASE3)
- EFFICACY AND TOLERABILITY OF BECLOMETHASONE DIPROPIONATE 100 µg + FORMOTEROL 6 µg pMDI VIA HFA-134a vs. FLUTICASONE 125 µg + SALMETEROL 25 µg pMDI (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |