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Fluticasone propionate

Phase 3

Bilateral Nasal Polyposis | Small molecule | ENT |OptiNose, Inc.|Last Updated: Dec 26, 2018

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 Trials2
Total Enrollment646
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01622569Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess SafetyPHASE3 COMPLETED 323Nov 19, 2013Oct 1, 2015Dec 26, 201833 United States, Canada
NCT01624662Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional DevicePHASE3 COMPLETED 323Oct 30, 2013Jul 3, 2015Dec 5, 201810 United States
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Study Endpoints
Primary Endpoints
Change in 7-day Average Instantaneous Morning Diary Congestion/Obstruction Symptoms
Baseline, Week 4 of the double-blind treatment phase

Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 0: None 1. Mild, symptoms clearly present, but minimal awareness, and easily tolerated 2. Moderate, definite awareness of symptoms that is bothersome but tolerable 3. Severe, symptoms that are hard to tolerate, cause interference with activities or daily living The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 4 Visit of the double-blind treatment phase

Change in Total Polyp Grade
Baseline, Week 16 of the double-blind treatment phase

Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. A summary of the changes from baseline to Week 16 in total polyp grade. 0: No polyps 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate Reduction in total polyp grade (sum of scores from both nasal cavities) at Week 16 of double-blind treatment phase; Included patients with nasal polyps at baseline

Secondary Endpoints
Congestion/Obstruction Scores (7-day Instantaneous Morning)
Baseline, Week 16 of the double-blind treatment phase
Change in Rhinorrhea Score (7-day Instantaneous Morning)
Baseline, Week 16 of the double-blind treatment phase
Facial Pain or Pressure Score (7-day Instantaneous Morning)
Baseline, Week 16 of the double-blind treatment phase
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
OPN-375 100 μg BIDACTIVE_COMPARATORDouble-Blind Treatment Phase: OPN-375 100 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks
PlaceboPLACEBO_COMPARATORDouble-Blind Treatment Phase: Matching Placebo BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks
OPN-375 200 μg BIDACTIVE_COMPARATORDouble-Blind Treatment Phase: OPN-375 200 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks
OPN-375 400 μg BIDACTIVE_COMPARATORDouble-Blind Treatment Phase: OPN-375 400 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks
OPN-375 100 mcgACTIVE_COMPARATORDouble-Blind Treatment Phase: OPN-375 100 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks
OPN-375 200 mcgACTIVE_COMPARATORDouble-Blind Treatment Phase: OPN-375 200 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks
OPN-375 400 mcgACTIVE_COMPARATORDouble-Blind Treatment Phase: OPN-375 400 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks
Interventions
NameTypeDescription
Fluticasone PropionateDRUGDelivered via Optinose Exhalation Delivery System
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites33

Inclusion Criteria: * Men or women aged 18 years and older * Women must * be practicing an effective method of birth control (eg,prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method \[eg, condoms, diaphragm, or cervical cap w...

Countries:United StatesCanada
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