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GFF MDI
GFF MDI is a combination inhaled corticosteroid and long-acting beta-2 agonist that reduces airway inflammation and improves bronchodilation in obstructive airway diseases.
GFF MDI is a combination inhaled corticosteroid and long-acting beta-2 agonist that reduces airway inflammation and improves bronchodilation in obstructive airway diseases. Used for Chronic obstructive pulmonary disease (COPD), Asthma.
At a glance
| Generic name | GFF MDI |
|---|---|
| Sponsor | Pearl Therapeutics, Inc. |
| Drug class | Combination inhaled corticosteroid / long-acting beta-2 agonist / long-acting muscarinic antagonist |
| Target | Beta-2 adrenergic receptor, muscarinic M3 receptor, glucocorticoid receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonology |
| Phase | Phase 3 |
Mechanism of action
The formulation combines glycopyrronium (a long-acting muscarinic antagonist), formoterol (a long-acting beta-2 agonist), and fluticasone propionate (an inhaled corticosteroid) delivered via metered-dose inhaler. This triple combination addresses multiple pathways in COPD and asthma by reducing inflammation, enhancing bronchodilation through dual mechanisms, and improving drug delivery consistency.
Approved indications
- Chronic obstructive pulmonary disease (COPD)
- Asthma
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Dysphonia
Key clinical trials
- A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (PHASE3)
- Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PHASE3)
- Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos) (PHASE3)
- Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects (PHASE1)
- A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos) (PHASE3)
- Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With COPD Compared With Symbicort® Turbohaler® (PHASE3)
- Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe COPD (PHASE3)
- A Study to Assess the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD (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 |