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Fluticasone 125/formoterol 5
Fluticasone/formoterol is a combination inhaled corticosteroid and long-acting beta-2 agonist that reduces airway inflammation and dilates airways to improve breathing.
Fluticasone/formoterol is a combination inhaled corticosteroid and long-acting beta-2 agonist that reduces airway inflammation and dilates airways to improve breathing. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | Fluticasone 125/formoterol 5 |
|---|---|
| Also known as | Flutiform 125 |
| Sponsor | Research in Real-Life Ltd |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination |
| Target | Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (formoterol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
Mechanism of action
Fluticasone propionate is a potent inhaled corticosteroid that suppresses inflammatory responses in the airways by binding to glucocorticoid receptors, reducing mucus production and airway edema. Formoterol is a long-acting beta-2 agonist that binds to beta-2 adrenergic receptors on airway smooth muscle, causing bronchodilation and sustained airway opening. Together, they provide both anti-inflammatory and bronchodilatory effects for maintenance asthma and COPD control.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness/anxiety
- Muscle cramps
Key clinical trials
- A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis (PHASE2, PHASE3)
- Efficacy of FLUTIFORM ® vs Seretide® in Moderate to Severe Persistent Asthma in Subjects Aged ≥12 Years (PHASE3)
- An Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy and Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent and Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma (PHASE3)
- A Study to Show That Flutiform is Well Tolerated and Effective in the Treatment of COPD (PHASE3)
- Assessment of the Efficacy and Safety of FlutiForm® pMDI 125/5 µg (2 Puffs Bid) Versus Symbicort® Turbohaler® 200/6 µg (2 Puffs Bid) in Adolescent and Adult Subjects With Moderate to Severe Persistent, Reversible Asthma (PHASE3)
- Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis (PHASE2, PHASE3)
- Flutiform® Compared With Seretide® in the Treatment of COPD (PHASE2, PHASE3)
- Monotherapy of Itraconazole Versus Prednisolone in Allergic Bronchopulmonary Aspergillosis (PHASE2, 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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fluticasone 125/formoterol 5 CI brief — competitive landscape report
- Fluticasone 125/formoterol 5 updates RSS · CI watch RSS
- Research in Real-Life Ltd portfolio CI