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Fluticasone/formoterol BAI
Fluticasone/formoterol combines a corticosteroid that reduces airway inflammation with a long-acting beta-2 agonist that relaxes airway smooth muscle to improve breathing.
Fluticasone/formoterol combines a corticosteroid that reduces airway inflammation with a long-acting beta-2 agonist that relaxes airway smooth muscle to improve breathing. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | Fluticasone/formoterol BAI |
|---|---|
| Sponsor | Mundipharma Research Limited |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA) |
| Target | Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (formoterol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Fluticasone propionate is an 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 adrenergic agonist (LABA) that binds to beta-2 receptors on airway smooth muscle, causing bronchodilation and sustained airway opening. Together, they provide both anti-inflammatory and bronchodilatory effects for asthma and COPD management.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness/anxiety
Key clinical trials
- A Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) or Relvar® Ellipta® DPI on Ventilation Heterogeneity in Asthma (PHASE3)
- A Study to Compare Fluticasone /Formoterol Breath Actuated Inhaler (BAI) and Ultibro in Subjects With Fixed Airflow Obstruction and Elevated Eosinophils (PHASE2, PHASE3)
- A Pharmacokinetic/Pharmacodynamic Inhaler Comparison Study in Healthy Volunteers (PHASE1)
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/formoterol BAI CI brief — competitive landscape report
- Fluticasone/formoterol BAI updates RSS · CI watch RSS
- Mundipharma Research Limited portfolio CI