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Flovent HFA 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

Flovent HFA 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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Frequently asked questions about Flovent HFA pressurized metered dose inhaler

What is Flovent HFA pressurized metered dose inhaler used for?

Flovent HFA pressurized metered dose inhaler is used for the treatment of asthma. It is a small molecule respiratory medication administered via a pressurized metered dose inhaler. The drug is being developed by Teva Pharmaceutical Industries Limited and is currently in Phase 3 clinical development for this indication.

What does Flovent HFA pressurized metered dose inhaler target?

Flovent HFA pressurized metered dose inhaler contains fluticasone propionate, a corticosteroid that works by reducing inflammation in the airways. It is delivered as a pressurized metered dose inhaler at a strength of 110 mcg. The drug is being studied for its therapeutic equivalence to Flovent HFA 110 mcg in patients with asthma.

Who makes Flovent HFA pressurized metered dose inhaler?

Flovent HFA pressurized metered dose inhaler is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker TEVA. The drug is currently in Phase 3 clinical development for the treatment of asthma, with one completed clinical trial involving 1,902 participants.

What phase is Flovent HFA pressurized metered dose inhaler in?

Flovent HFA pressurized metered dose inhaler is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of asthma, and one Phase 3 clinical trial has been completed to evaluate its therapeutic equivalence to Flovent HFA 110 mcg.

What clinical trials is Flovent HFA pressurized metered dose inhaler in?

Flovent HFA pressurized metered dose inhaler has one completed Phase 3 clinical trial registered under NCT03879837. The trial, titled "Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg," enrolled 1,902 participants with asthma in the United States. The study was randomized, double-blind, and placebo-controlled.

Is Flovent HFA pressurized metered dose inhaler the same as Flovent HFA?

Flovent HFA pressurized metered dose inhaler is being studied as a therapeutic equivalent to Flovent HFA 110 mcg. The clinical trial NCT03879837 was designed to evaluate whether the fluticasone propionate pressurized metered dose inhaler at 110 mcg is equivalent to the reference product Flovent HFA 110 mcg in patients with asthma.