Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Fluticasone Propionate, Fluticasone Propionate and Salmeterol Inhalation Powder, Fluticasone Propionate and Salmeterol
Fluticasone Propionate/Salmeterol MDPI · 2 trials · 1 indication
Baseline-adjusted area under the serial FEV1-time curve calculated from time zero to 12 hours (AUC0-12h) on Day 1 of treatment. LSMeans will be used for the statistical analysis. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.
Baseline-adjusted pre-dose FEV1 measured in the morning following 28 days of treatment. Only the active treatments (test and reference) are compared in this analysis. The placebo arm was used in superiority analysis only.
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. The baseline 1-hour trough morning percent predicted FEV1 was defined as the predose trough morning percent predicted FEV1 measurement at the randomization visit (Baseline \[Day 1\]) at the investigational center. The IMP dose was administered right after the predose FEV1 measurement (within a 10 minute window). Participant then performed 1-hour (±10 minutes) postdose lung function assessments on Week 12 at the investigational center.
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. Baseline trough morning percent predicted FEV1 was defined as the average value of recorded (nonmissing) morning assessments 5 out of the last 7 days prior to randomization. The first day before randomization consisted of the electronic patient diary entry at home on the morning of the randomization visit (Baseline \[Day 1\]) and the first day postrandomization consisted of the electronic patient diary entry at home on the morning of the day after the randomization visit (Baseline \[Day 1\]). For postdose weekly average of trough morning percent predicted FEV1 measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of morning FEV1 values divided by the number of nonmissing assessments.
| Arm | Type | Description |
|---|---|---|
| Test | EXPERIMENTAL | Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg |
| Reference | ACTIVE_COMPARATOR | ADVAIR DISKUS® 100/50 (fluticasone propionate and salmeterol) Inhalation Powder |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Placebo MDPI | PLACEBO_COMPARATOR | Participants received matching placebo via multidose dry powder inhaler (MDPI) for 12 weeks. |
| Fp MDPI 25 mcg BID | EXPERIMENTAL | Participants received 1 inhalation of 25 mcg fluticasone propionate (Fp) via MDPI twice daily (BID) (total daily dose: 50 mcg) for 12 weeks. |
| Fp MDPI 50 mcg BID | EXPERIMENTAL | Participants received 1 inhalation of 50 mcg fluticasone propionate via MDPI BID (total daily dose: 100 mcg) for 12 weeks. |
| FS MDPI 50/12.5 mcg BID | EXPERIMENTAL | Participants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol (FS) via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Fluticasone Propionate and Salmeterol Inhalation Powder | DRUG | 100/50 mcg per actuation |
| Placebo Inhalation Powder | DRUG | No active content |
| Fluticasone Propionate | DRUG | Fluticasone propionate was administered via MDPI per the dose and schedule specified in the arm. |
| Fluticasone Propionate/Salmeterol | DRUG | Fluticasone propionate/salmeterol was administered via MDPI per the dose and schedule specified in the arm. |
| Placebo MDPI | DRUG | Matching placebo was administered via MDPI per the schedule specified in the arm. |
Inclusion Criteria: 1. Male or non-pregnant, non-lactating female, ≥ 12 years and ≤ 75 years of age. 2. Signed informed consent form that meets all criteria of current Food and Drug Administration (FDA) regulations. For subjects who are considered minors in the state the study is being conducted (\...
Fluticasone Propionate is an inhaled corticosteroid used for the treatment of asthma. It is being developed by Teva Pharmaceutical Industries Limited (TEVA) and is currently in Phase 3 clinical development. The drug is administered via a multidose dry powder inhaler and is intended to manage asthma symptoms.
Fluticasone Propionate is a small molecule corticosteroid that works by reducing inflammation in the airways, which helps to improve asthma control. It is delivered directly to the lungs via inhalation, where it acts locally to decrease airway inflammation and hyperresponsiveness.
Fluticasone Propionate is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker TEVA. Teva is conducting clinical trials to evaluate the drug's safety and efficacy in patients with asthma.
Fluticasone Propionate is in Phase 3 clinical development for the treatment of asthma. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions.
Fluticasone Propionate has one completed Phase 3 clinical trial, identified as NCT02980133. This randomized, double-blind, placebo-controlled study enrolled 841 participants with asthma and compared Fluticasone Propionate multidose dry powder inhaler with a combination of Fluticasone Propionate and Salmeterol. The trial was conducted in the United States, Georgia, Hungary, Russia, and Ukraine.
Fluticasone Propionate is not the same as Fluticasone Propionate/Salmeterol. Fluticasone Propionate is a single-ingredient inhaled corticosteroid, while Fluticasone Propionate/Salmeterol is a combination product that includes both a corticosteroid and a long-acting beta-agonist. The two were compared in a clinical trial for asthma.