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FlutiForm 250/10
FlutiForm combines fluticasone propionate (an inhaled corticosteroid) with formoterol (a long-acting beta-2 agonist) to reduce airway inflammation and improve bronchial smooth muscle relaxation.
FlutiForm combines fluticasone propionate (an inhaled corticosteroid) with formoterol (a long-acting beta-2 agonist) to reduce airway inflammation and improve bronchial smooth muscle relaxation. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).
At a glance
| Generic name | FlutiForm 250/10 |
|---|---|
| Sponsor | SkyePharma AG |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist (ICS/LABA) combination |
| Target | Glucocorticoid receptor (fluticasone); beta-2 adrenergic receptor (formoterol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Fluticasone propionate binds to glucocorticoid receptors in the airways, suppressing inflammatory cell recruitment and cytokine production. Formoterol activates beta-2 adrenergic receptors on airway smooth muscle, causing bronchodilation. The combination provides both anti-inflammatory and bronchodilator effects in a single inhaled formulation.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD)
Common side effects
- Tremor
- Headache
- Palpitations
- Oral candidiasis
- Nervousness/anxiety
Key clinical trials
- Efficacy of FLUTIFORM ® vs Seretide® in Moderate to Severe Persistent Asthma in Subjects Aged ≥12 Years (PHASE3)
- Study of FlutiForm® Versus Fluticasone Plus Formoterol in Adult Subjects With Severe Asthma (PHASE3)
- A Study to Show That Flutiform is Well Tolerated and Effective in the Treatment of COPD (PHASE3)
- Flutiform® Compared With Seretide® in the Treatment of COPD (PHASE2, PHASE3)
- A Guideline Approach to Therapy Step-down Utilising Flutiform Change and Step-down (PHASE4)
- A Phase 3, Multicenter, Open-label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed FlutiForm HFA pMDI Study SKY2028-3-005 (PHASE3)
- Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients (PHASE2)
- 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)
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:
- FlutiForm 250/10 CI brief — competitive landscape report
- FlutiForm 250/10 updates RSS · CI watch RSS
- SkyePharma AG portfolio CI