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FF MDI
FF MDI is a combination inhaled corticosteroid and long-acting beta-2 agonist for maintenance treatment of asthma and COPD.
FF MDI is a combination inhaled corticosteroid and long-acting beta-2 agonist for maintenance treatment of asthma and COPD. Used for Asthma maintenance treatment, Chronic obstructive pulmonary disease (COPD) maintenance treatment.
At a glance
| Generic name | FF MDI |
|---|---|
| Sponsor | Pearl Therapeutics, Inc. |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination |
| Target | Glucocorticoid receptor; Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
The formulation combines fluticasone furoate (ICS) with a long-acting beta-2 agonist delivered via metered-dose inhaler. The corticosteroid reduces airway inflammation and immune response, while the beta-2 agonist promotes bronchial smooth muscle relaxation and bronchodilation. This dual mechanism provides both anti-inflammatory and bronchodilatory effects for chronic respiratory disease management.
Approved indications
- Asthma maintenance treatment
- Chronic obstructive pulmonary disease (COPD) maintenance treatment
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)
- Real-World Effectiveness of a Triple Combination BDP/FF/GB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients
- 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)
- Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma (PHASE2)
- Real-World Effectiveness of a Triple Combination BDP/FF/GB in a Single Pressurised Metered Dose Inhaler in COPD Patients (TRIPHY)
- Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Doses and QVAR® (PHASE1)
- A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV) (PHASE1)
- CHF5993 and CHF1535 pMDI on Lung Hyperinflation and Exercise Endurance Time in Subjects With COPD (PHASE4)
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:
- FF MDI CI brief — competitive landscape report
- FF MDI updates RSS · CI watch RSS
- Pearl Therapeutics, Inc. portfolio CI