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Fluticasone propionate pressurized metered dose inhaler

Phase 3

Asthma | Small molecule | Respiratory |Teva Pharmaceutical Industries Limited|Last Updated: Sep 1, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment1,902

FDA Designations

No designations recorded

Clinical trial landscape

Fluticasone propionate pressurized metered dose inhaler · 1 trial · 1 indication

Phase 3 1
NCT03879837Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcgAsthma
COMPLETED1,902 Analytics
PHASE3COMPLETED
Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change in baseline adjusted morning pre-dose FEV1 from the time of treatment randomization to Week 4.
4 weeks

Secondary Endpoints

Superiority over Placebo
Approximately 4 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Investigational Test ProductEXPERIMENTALFluticasone propionate pressurized metered dose inhaler, 110 mcg per actuation
Reference Listed DrugACTIVE_COMPARATORFlovent HFA pressurized metered dose inhaler, 110 mcg per actuation
PlaceboPLACEBO_COMPARATORPlacebo pressurized metered dose inhaler, no active content

Interventions

NameTypeDescription
Fluticasone propionate pressurized metered dose inhalerDRUG110 mcg per actuation
Flovent HFA pressurized metered dose inhalerDRUG110 mcg per actuation
Placebo pressurized metered dose inhalerDRUGno active content
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Adult ≥18 and ≤75 years of age male or female subjects of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control. 2. Body mass index (BMI) ≥18 and ≤45. 3. Diagnosis of asthma, as defined by t...

Countries:United States
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