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SKP FlutiForm HFA pMDI
SKP FlutiForm HFA is a combination inhaled corticosteroid (fluticasone propionate) and long-acting beta-2 agonist (formoterol) delivered via pressurized metered-dose inhaler for maintenance treatment of asthma.
SKP FlutiForm HFA is a combination inhaled corticosteroid (fluticasone propionate) and long-acting beta-2 agonist (formoterol) delivered via pressurized metered-dose inhaler for maintenance treatment of asthma. Used for Asthma maintenance therapy.
At a glance
| Generic name | SKP FlutiForm HFA pMDI |
|---|---|
| Also known as | FlutiForm, fluticasone propionate/formoterol fumarate |
| Sponsor | SkyePharma AG |
| 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
Fluticasone propionate reduces airway inflammation by binding to glucocorticoid receptors, while formoterol provides bronchodilation through beta-2 adrenergic receptor agonism. The combination addresses both the inflammatory and bronchospastic components of asthma, with the HFA propellant system enabling efficient lung deposition.
Approved indications
- Asthma maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness
Key clinical trials
- Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma (PHASE3)
- Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma (PHASE3)
- A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005 (PHASE3)
- New Combination Inhaler (FlutiForm HFA MDI 100/10 µg and 250/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma (PHASE3)
- A Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™) With Fluticasone or Flovent to Treat Moderate to Severe Asthma in Adolescents and Adults (PHASE3)
- Single-dose Crossover Study to Evaluate the Early Bronchodilating Effect of FlutiForm HFA pMDI in Adult Subjects With Mild to Moderate Asthma (PHASE2)
- A Phase I Study in Asthma Patients Evaluating the Effect of Doses of FlutiForm™ on the Amount, if Any, of Cortisol Produced by the Adrenal Glands (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:
- SKP FlutiForm HFA pMDI CI brief — competitive landscape report
- SKP FlutiForm HFA pMDI updates RSS · CI watch RSS
- SkyePharma AG portfolio CI