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Fluticasone Propionate via ACCUHALER/DISKUS · 1 trial · 1 indication
Pulmonary function was measured by forced expiratory volume in one second, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the morning (AM) pre-dose and pre-rescue bronchodilator FEV1 at the clinic visit. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the end of Week 8 value minus the Baseline value. Analysis of covariance (ANCOVA) model used for statistical analysis. ITT Population was comprised of all participant randomized to treatment who received at least one dose of double-blind study medication.
| Arm | Type | Description |
|---|---|---|
| GSK2190915 10mg and placebo | EXPERIMENTAL | GSK2190915 10mg (1 x 10mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS |
| GSK2190915 30mg and placebo | EXPERIMENTAL | GSK2190915 30mg (1 x 30mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS |
| GSK2190915 100mg QD and placebo | EXPERIMENTAL | GSK2190915 100mg (1 x 100mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS |
| GSK2190915 300mg QD and placebo | EXPERIMENTAL | GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS |
| Fluticasone propionate 100mcg and placebo | ACTIVE_COMPARATOR | Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS and two placebo tablets in the morning and one placebo capsule in the evening |
| Montelukast 10mg and placebo | ACTIVE_COMPARATOR | Montelukast 10mg (1 x 10mg capsule) once daily in the evening and two placebo tablets in the morning and inhaled placebo twice daily via ACCUHALER/DISKUS |
| Placebo Comparator | PLACEBO_COMPARATOR | Two GSK2190915 placebo tablets once daily in the morning, montelukast placebo capsule once daily in the evening and fluticasone propionate placebo twice daily via ACCUHALER/DISKUS |
| Name | Type | Description |
|---|---|---|
| Fluticasone Propionate 100mcg via ACCUHALER/DISKUS | DRUG | Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS |
| GSK2190915 100mg | DRUG | GSK2190915 100mg (1 x 100mg) once daily in the morning |
| GSK2190915 10mg | DRUG | GSK2190915 10mg (1 x 10mg) once daily in the morning |
| GSK2190915 300mg | DRUG | GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning |
| GSK2190915 30mg | DRUG | GSK2190915 30mg (1 x 30mg) once daily in the morning |
| Montelukast 10mg | DRUG | Montelukast 10mg (1 x 10mg capsule) once daily in the evening |
| Placebo GSK2190915 one tablet | DRUG | Placebo tablet, one tablet once daily in the morning |
| Placebo montelukast | DRUG | Placebo capsule once daily in the evening |
| Placebo fluticasone propionate via ACCUHALER/DISKUS | DRUG | Inhaled placebo twice daily via ACCUHALER/DISKUS |
| Placebo GSK2190915 two tablets | DRUG | Placebo tablet, two tablets once daily in the morning |
Inclusion Criteria: * Type of Subject: Outpatient * Age: ≥12 years of age * Gender: Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control) * Asthma Diagnosis: As defined by NIH * Severity of Disease: FEV1 50-85% predict...
Fluticasone Propionate via ACCUHALER/DISKUS is used for the treatment of asthma. It is an investigational small molecule being studied in a Phase 2 clinical trial for this respiratory condition. The drug is administered through the ACCUHALER or DISKUS inhalation devices.
Fluticasone Propionate via ACCUHALER/DISKUS is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker symbol GSK. The company is conducting clinical research to evaluate the drug's efficacy and safety in patients with asthma.
Fluticasone Propionate via ACCUHALER/DISKUS is in Phase 2 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to determine its safety and effectiveness for treating asthma.
Fluticasone Propionate via ACCUHALER/DISKUS is associated with one completed clinical trial, identified by the National Clinical Trial number NCT01147744. This Phase 2 study was a dose-ranging evaluation of the drug's efficacy and safety, enrolling 700 participants with asthma across multiple countries.
Fluticasone Propionate via ACCUHALER/DISKUS is not the same as GSK2190915. The clinical trial NCT01147744 evaluated GSK2190915, a separate investigational drug, while Fluticasone Propionate via ACCUHALER/DISKUS is a different medication being studied for asthma. They are distinct compounds with different mechanisms of action.