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Fluticasone Propionate

Phase 3

Asthma | Small molecule | Respiratory |Teva Pharmaceutical Industries Limited|Last Updated: Nov 9, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment841
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02980133Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder InhalerPHASE3 COMPLETED 841Dec 28, 2016Apr 13, 2019Nov 9, 2021118 United States, Georgia +3
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Study Endpoints
Primary Endpoints
For FS MDPI Versus Fp MDPI: Change From Baseline in 1-Hour Postdose Percent Predicted Morning Forced Expiratory Volume in 1 Second (FEV1) at Week 12
Baseline, Week 12

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.

For Fp MDPI Versus Placebo: Change From Baseline in Weekly Average of the Percent Predicted Trough Morning FEV1 at Week 12
Baseline, Week 12

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.

Secondary Endpoints
Change From Baseline in the Weekly Average of Daily Trough Morning (Predose and Pre-Rescue Bronchodilator) Peak Expiratory Flow (PEF) Over the 12 Week Treatment Period
Baseline, Week 1 to 12
Change From Baseline in the Weekly Average of Total Daily (24 Hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1 Through 12
Baseline, Week 1 to 12
Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1 Through 12
Baseline, Week 1 to 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo MDPIPLACEBO_COMPARATORParticipants received matching placebo via multidose dry powder inhaler (MDPI) for 12 weeks.
Fp MDPI 25 mcg BIDEXPERIMENTALParticipants 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 BIDEXPERIMENTALParticipants 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 BIDEXPERIMENTALParticipants received 1 inhalation of 50/12.5 mcg fluticasone propionate/salmeterol (FS) via MDPI BID (total daily dose: 100/25 mcg) for 12 weeks.
Interventions
NameTypeDescription
Fluticasone PropionateDRUGFluticasone propionate was administered via MDPI per the dose and schedule specified in the arm.
Fluticasone Propionate/SalmeterolDRUGFluticasone propionate/salmeterol was administered via MDPI per the dose and schedule specified in the arm.
Placebo MDPIDRUGMatching placebo was administered via MDPI per the schedule specified in the arm.
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Eligibility Criteria
Age Range4 Years — 11 Years
SexALL
Healthy VolunteersNo
Study Sites118

Inclusion Criteria: * The participant has a diagnosis of asthma as defined by the National Institutes of Health (NIH). * The participant has persistent asthma with a FEV1 ≥50% and ≤90% of the value predicted for age, height, sex, and race at the screening visit (SV). * The participant's persistent ...

Countries:United StatesGeorgiaHungaryRussiaUkraine
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