Last updated 11 days ago

A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma

724 patients around the world

Available in Argentina, United States

Teva Branded Pharmaceutical Products R&D, Inc.

724Patients around the world

This study is for people with

Asthma

From 12 Years

All Gender

: The participant has a diagnosis of asthma of at least 6 months duration.
Participants currently receive a beta-agonist as rescue medication with or without asthma controller medication.
If female, a participant is currently not pregnant, breastfeeding, or attempting to become pregnant for at least 30 days before the screening visit and throughout the duration of the trial, or is of non-childbearing potential.

: The participant has a history of life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation, associated with hypercapnia, respiratory arrest, hypoxic seizures or an asthma related syncopal episode.
The participant has had an upper or lower respiratory tract infection within 2 weeks or has had a confirmed case of COVID-19 within 6 weeks prior to Visit 1.
Symptoms of the infection(s) must be completely resolved prior to entering screening.
The participant is a current smoker and/or has a history of ≥10 pack years history of smoking.
A current smoker is defined as any participant who has used any form of tobacco product within the past 6 months.
The participant has another confounding underlying lung disorder or participants with a diagnosis of asthma COPD overlap syndrome.

SponsorTeva Branded Pharmaceutical Products R&D, Inc.

Study typeInterventional

Conditions

Asthma

Requirements

From 12 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06664619