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FF MDI (PT005)
FF MDI is a combination inhaled corticosteroid (fluticasone propionate) and long-acting beta-2 agonist (formoterol) metered-dose inhaler for maintenance treatment of asthma and COPD.
FF MDI is a combination inhaled corticosteroid (fluticasone propionate) and long-acting beta-2 agonist (formoterol) metered-dose inhaler 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 (PT005) |
|---|---|
| Also known as | Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol, formoterol fumarate metered dose inhaler (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 |
| Phase | Phase 3 |
Mechanism of action
The fluticasone propionate component reduces airway inflammation by binding to glucocorticoid receptors, while formoterol acts as a long-acting beta-2 agonist to relax bronchial smooth muscle and improve airflow. This dual mechanism provides both anti-inflammatory and bronchodilatory effects in a single inhaled formulation.
Approved indications
- Asthma maintenance treatment
- Chronic obstructive pulmonary disease (COPD) maintenance treatment
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness
Key clinical trials
- A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos) (PHASE3)
- Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD (PHASE3)
- A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD (PHASE3)
- Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PHASE3)
- Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (PHASE2)
- Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1) (PHASE3)
- Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2) (PHASE3)
- Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3) (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 |