Recent Updates
Recently added Catalysts

Fluticasone propionate pressurized metered dose inhaler

Phase 3

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

Fluticasone propionate pressurized metered dose inhaler development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Mar 2001

Fluticasone propionate pressurized metered dose inhaler target and mechanism

ModalitySmall molecule

Also known as Flovent HFA pressurized metered dose inhaler

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment1,902

FDA Designations

No designations recorded

Fluticasone propionate pressurized metered dose inhaler clinical trials

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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Fluticasone propionate pressurized metered dose inhaler

What is fluticasone propionate pressurized metered dose inhaler?

Fluticasone propionate pressurized metered dose inhaler is an investigational inhaled asthma therapy developed by Teva Pharmaceutical Industries Limited. It delivers fluticasone propionate, a small molecule, at a 110 mcg dose. It is being studied as a therapeutic equivalent to Flovent HFA 110 mcg for treating asthma in adults.

What is fluticasone propionate pressurized metered dose inhaler used for?

Fluticasone propionate pressurized metered dose inhaler is being developed for the treatment of asthma. The Phase 3 program evaluated it in adults 18 years and older with asthma in the United States. It is designed as a pressurized metered dose inhaler delivering 110 mcg of fluticasone propionate per actuation.

Who makes fluticasone propionate pressurized metered dose inhaler?

Teva Pharmaceutical Industries Limited is developing fluticasone propionate pressurized metered dose inhaler. Teva trades on the New York Stock Exchange under the ticker TEVA. The company sponsored the Phase 3 therapeutic equivalence study of the 110 mcg inhaler against Flovent HFA 110 mcg.

What phase is fluticasone propionate pressurized metered dose inhaler in?

Fluticasone propionate pressurized metered dose inhaler has completed a Phase 3 clinical trial. It is an investigational product and is not described as approved. The Phase 3 study, NCT03879837, has been completed and enrolled 1,902 participants.

What clinical trials is fluticasone propionate pressurized metered dose inhaler in?

Fluticasone propionate pressurized metered dose inhaler was studied in one Phase 3 trial, NCT03879837, titled Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent HFA 110 mcg. The trial was completed, enrolled 1,902 adults with asthma in the United States, and was randomized, double blind, and placebo controlled.