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FlutiForm 250 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | FlutiForm 250/10 ug |
| 2 | EXPERIMENTAL | FlutiForm 100/10 ug |
| 3 | ACTIVE_COMPARATOR | Oral Prednisone 10 mg |
| 4 | PLACEBO_COMPARATOR | Placebo inhaler and/or placebo tablets |
| Name | Type | Description |
|---|---|---|
| FlutiForm 250/10 ug | DRUG | SKP 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 6 weeks. |
| FlutiForm 100/10 ug | DRUG | SKP 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 6 weeks. |
| Oral Prednisone 10mg | DRUG | 2 x 5 mg oral prednisone tablets, over encapsulated, once a day for one week. |
| Placebo | DRUG | 2 x 5 mg placebo tablets, over encapsulated, once a day for six weeks. SKP FlutiForm placebo HFA pMDI. Two actuations BID for six weeks. |
Inclusion Criteria: * Age 18-65 at the Screening Visit; * History of asthma for at least 6 months prior to Screening Visit * Well controlled asthma with rescue short acting beta agonist (albuterol) and or stable doses of other medications for at least 4 weeks prior to Screening Visit * Female subje...
FlutiForm 250 is an investigational small molecule being developed for the treatment of asthma. It is a combination product containing a corticosteroid and a long-acting beta-agonist, designed to reduce inflammation and open airways in patients with asthma. It is currently in Phase 1 clinical development.
FlutiForm 250 is being developed by Pacira BioSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PCRX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational asthma treatment.
FlutiForm 250 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and pharmacological effects in patients with asthma.
FlutiForm 250 has one completed Phase 1 clinical trial, identified as NCT00657774. This randomized, double-blind, placebo-controlled study enrolled 160 asthma patients in the United States to evaluate the effect of FlutiForm doses on cortisol production by the adrenal glands.
FlutiForm 250 is a combination of a corticosteroid and a long-acting beta-agonist. The corticosteroid reduces airway inflammation, while the long-acting beta-agonist relaxes bronchial smooth muscle to relieve bronchoconstriction. Together, these mechanisms help manage asthma symptoms by decreasing inflammation and improving airflow.