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CHF 1535
CHF 1535 is a dual bronchodilator that combines a long-acting beta-2 agonist with a long-acting muscarinic antagonist to improve airway function in chronic obstructive pulmonary disease.
CHF 1535 is a dual bronchodilator that combines a long-acting beta-2 agonist with a long-acting muscarinic antagonist to improve airway function in chronic obstructive pulmonary disease. Used for Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | CHF 1535 |
|---|---|
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | LABA/LAMA combination (Long-Acting Beta-2 Agonist / Long-Acting Muscarinic Antagonist) |
| Target | Beta-2 adrenergic receptor and M3 muscarinic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | Phase 3 |
Mechanism of action
The drug works through two complementary pathways: the beta-2 agonist component stimulates beta-2 adrenergic receptors to relax airway smooth muscle, while the muscarinic antagonist blocks M3 receptors to prevent acetylcholine-induced bronchoconstriction. This dual mechanism provides synergistic bronchodilation and improved lung function in COPD patients.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Dry mouth
- Nasopharyngitis
Key clinical trials
- 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)
- A Phase II, 5-way Cross-over Study to Evaluate the Pharmacodynamics of "Nexthaler" Dry Powder Inhaler in COPD Patients (PHASE2)
- Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD (PHASE3)
- Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI) (PHASE2)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |