Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
Fluticasone propionate via ACCUHALER/DISKUS is an inhaled asthma treatment delivered through the ACCUHALER/DISKUS dry powder inhaler. It is a small molecule therapy in the respiratory therapeutic area, developed by GSK plc under the ticker GSK. The ACCUHALER/DISKUS device delivers a fixed dose of fluticasone propionate to the airways.
GSK plc, which trades under the ticker GSK, is the developer of fluticasone propionate via ACCUHALER/DISKUS. The product combines the corticosteroid fluticasone propionate with the ACCUHALER/DISKUS dry powder inhaler device for delivery in asthma.
Fluticasone propionate via ACCUHALER/DISKUS is in Phase 2 development for asthma. The program has one completed Phase 2 trial and no active trials at this time. It remains an investigational asset rather than a newly approved product in this development record.
The Phase 2 trial NCT01147744 evaluated fluticasone propionate via ACCUHALER/DISKUS in asthma. It was a randomized, double-blind, placebo-controlled dose-ranging study that enrolled 700 participants across the United States, Bulgaria, Japan, Poland, Romania, and Ukraine. Participants were female and at least 12 years old, and the trial is completed.
The Phase 2 asthma trial NCT01147744 for fluticasone propionate via ACCUHALER/DISKUS enrolled 700 participants. It was randomized, double-blind, and placebo-controlled, with enrollment across the United States, Bulgaria, Japan, Poland, Romania, and Ukraine. The study included female participants aged 12 years and older and is now completed.