Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
100 micrograms Fluticasone propionate · 1 trial · 1 indication
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 4-10 hours post-allergen challenge is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 4-10 hours post-allergen challenge is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 6. The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. LAR WM FEV1 was measured at 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 6. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 6. The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. LAR WM FEV1 was measured at 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 6. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.
| Arm | Type | Description |
|---|---|---|
| 3 periods cross-over study | PLACEBO_COMPARATOR | Each subject will receive each intervention BID during a 7 days period. The treatment periods are separated by 14 days washout. The sequence in which the interventions are administered are at random and double blind. |
| Name | Type | Description |
|---|---|---|
| 100 micrograms Fluticasone propionate | DRUG | 100 micrograms micronized drug blended with lactose in dry powder inhalator |
| 500 micrograms Fluticasone propionate | DRUG | 500 micrograms micronized drug blended with lactose in dry powder inhalator |
| lactose powder | DRUG | lactose powder in dry powder device : placebo comparator |
Inclusion Criteria: * males and females between 18 and 55 years of age inclusive * female subject of child-bearing potential and agrees to use one of the contraception methods; or of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterecto...
100 micrograms Fluticasone propionate is an inhaled corticosteroid being studied for the treatment of asthma. It is a small molecule developed by GSK plc. The drug is currently in Phase 2 clinical development and is considered investigational, meaning it has not yet been approved for general use.
GSK plc, traded under the ticker GSK, is developing 100 micrograms Fluticasone propionate. The company is conducting clinical research on this inhaled corticosteroid for asthma. The drug is in Phase 2 development, and GSK is the sponsor of the ongoing clinical program.
100 micrograms Fluticasone propionate is in Phase 2 clinical development for asthma. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug is being evaluated for its effects in asthmatic patients.
100 micrograms Fluticasone propionate has one completed Phase 2 clinical trial registered under NCT01400906. The trial, titled "Inhalation of Corticosteroids in Smoking and Non-smoking Asthmatics," enrolled 36 participants with asthma in Belgium and the United Kingdom. The study was randomized, double-blind, and placebo-controlled.
100 micrograms Fluticasone propionate is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for asthma. The completed Phase 2 trial, NCT01400906, evaluated the drug in 36 patients, but regulatory approval has not been granted, and the drug remains under investigation.