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fluticasone propionate, formoterol · 6 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | FlutiForm 100/10 μg |
| 2 | ACTIVE_COMPARATOR | Fluticasone 100 μg |
| 3 | ACTIVE_COMPARATOR | Formoterol 10 μg |
| 4 | PLACEBO_COMPARATOR | Placebo |
| 5 | PLACEBO_COMPARATOR | Placebo |
| I | PLACEBO_COMPARATOR | * Period 1 Treatment Regimen A: FlutiForm 250/10 ug * Period 2 Treatment Regimen B: FlutiForm 100/10 ug * Period 3 Treatment Regimen C: placebo |
| II | PLACEBO_COMPARATOR | * Period 1 Treatment Regimen B: FlutiForm 100/10 ug * Period 2 Treatment Regimen C: placebo * Period 3 Treatment Regimen A: FlutiForm 250/10 ug |
| III | PLACEBO_COMPARATOR | * Period 1 Treatment Regimen C: placebo * Period 2 Treatment Regimen A: FlutiForm 250/10 ug * Period 3 Treatment Regimen B: FlutiForm 100/10 ug |
| 6 | ACTIVE_COMPARATOR | * Period 1 Treatment Regimen F: Placebo * Period 2 Treatment Regimen E: Foradil Aerolizer 12 ug * Period 3 Treatment Regimen D: Flixotide Evohaler 250 ug * Period 4 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug |
| Name | Type | Description |
|---|---|---|
| Fluticasone propionate/formoterol fumarate 100/10 | DRUG | FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks. |
| Fluticasone propionate 100 | DRUG | Fluticasone 100ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks. |
| Formoterol fumarate 10 | DRUG | Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks. |
| Placebo | DRUG | Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks. |
| Fluticasone propionate/Formoterol fumarate 250/10 | DRUG | FlutiForm 250/10ug is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks. |
| Fluticasone propionate 250 | DRUG | Fluticasone 250 is a HFA pMDI that delivers 125ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks. |
| Fluticasone propionate/formoterol fumarate | DRUG | - |
| fluticasone propionate, formoterol fumarate | DRUG | ● Period 1 Treatment Regimen A: FlutiForm 250/10 ug FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation) ● Period 2 Treatment Regimen B: FlutiForm 100/10 ug FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation) ● Period 3 Treatment Regimen C: placebo SKP placebo; (two actuations) |
Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring or steroid-free. Inclusion Criteria: * History of asthma for at least 12 months. * For steroid-requiring patients, documented use of inhaled corticosteroid for at least 4 weeks prior...
Fluticasone propionate, formoterol is an investigational combination inhaler being developed for the treatment of asthma, including mild to moderate asthma. It combines a corticosteroid and a long-acting bronchodilator in a single metered-dose inhaler for patients aged 12 years and older.
Fluticasone propionate, formoterol is being developed by Pacira BioSciences, Inc. (NASDAQ: PCRX). The company is conducting clinical trials of this combination inhaler for asthma, with studies completed in the United States, Puerto Rico, Canada, and several European countries.
Fluticasone propionate, formoterol is in Phase 3 clinical development for asthma. It is an investigational drug and has not been approved by the FDA. Five clinical trials have been completed, including four Phase 3 studies and one Phase 2 study, with a total enrollment of 1,853 patients.
Fluticasone propionate, formoterol has completed five clinical trials, including NCT00393952, NCT00393991, and NCT00394121, which were Phase 3 studies comparing the combination inhaler to fluticasone and formoterol administered alone, and placebo in patients with asthma. A Phase 2 study, NCT00830102, evaluated safety and efficacy in a single-dose crossover design.
Fluticasone propionate, formoterol is a combination inhaler containing fluticasone propionate, a corticosteroid that reduces airway inflammation, and formoterol, a long-acting beta2-agonist that relaxes airway muscles to improve breathing. The combination is designed to provide both anti-inflammatory and bronchodilator effects for asthma management.
Yes, fluticasone propionate, formoterol is also known as FlutiForm. Clinical trials refer to the combination as FlutiForm HFA MDI, with doses of 100/10 µg and 250/10 µg, administered via a hydrofluoroalkane metered-dose inhaler for the treatment of asthma.