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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

RecruitingPhase 3

A 4-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Fluticasone Propionate/Albuterol Sulfate Combination Compared to Fluticasone Propionate, Albuterol Sulfate or Placebo Delivered by Multidose Dry Powder Inhaler in Participants 12 Years and Older With Asthma

Who can join

Ages 12 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* The participant has a diagnosis of asthma of at least 6 months duration.
* Participants currently receive a beta-agonist (eg, salbutamol \[albuterol\] or ICS albuterol or ICS-formoterol) 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.

NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* 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 (including oral) within the past 6 months, or any orally inhaled products including but not limited to cigarettes, beedis, vaping/ e-cigarettes, hookah/waterpipes, or marijuana. Note: participants with a positive urinary cotinine test will be excluded.
* The participant has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, pulmonary fibrosis), or participants with a diagnosis of asthma COPD overlap syndrome.

NOTE- Additional criteria apply, please contact the investigator for more information

About the study

The primary objective of the trial is to evaluate the efficacy of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI).

Secondary objectives are:

* To evaluate the efficacy of Fp/ABS eMDPI administered four times daily * To evaluate the safety and tolerability of Fp/ABS eMDPI administered four times daily over four weeks * To investigate the pharmacokinetics of Fp/ABS eMDPI, ABS eMDPI and Fp eMDPI after administration of a single dose

The planned study duration for each participant is approximately 10 weeks, excluding an optional prescreening visit.

What is being tested

Sponsor: Teva Branded Pharmaceutical Products R&D LLC · Participants: 724 · Started: Dec 12, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06664619

Locations in the U.S.

ArizonaTeva Investigational Site 12087, Phoenix
Teva Investigational Site 12146, Tucson
ArkansasTeva Investigational Site 12102, Little Rock
CaliforniaTeva Investigational Site 12154, Encinitas
Teva Investigational Site 12103, Huntington Beach
Teva Investigational Site 12068, La Palma
Teva Investigational Site 12152, Laguna Niguel
Teva Investigational Site 12145, Long Beach
Teva Investigational Site 12088, Los Angeles
Teva Investigational Site 12094, Los Angeles
Teva Investigational Site 12161, Northridge
Teva Investigational Site 12105, Oxnard
Teva Investigational Site 12064, San Jose
ColoradoTeva Investigational Site 12142, Lakewood
FloridaTeva Investigational Site 12079, Melbourne
Teva Investigational Site 12071, Miami
Teva Investigational Site 12074, Miami
Teva Investigational Site 12086, Miami
Teva Investigational Site 12097, Miami
Teva Investigational Site 12075, Pompano Beach
Teva Investigational Site 12078, Tampa
GeorgiaTeva Investigational Site 12175, Conyers
IdahoTeva Investigational Site 12156, Boise
IllinoisTeva Investigational Site 12162, Westchester
LouisianaTeva Investigational Site 12169, Shreveport
MarylandTeva Investigational Site 12106, Towson
Teva Investigational Site 12157, White Marsh
MassachusettsTeva Investigational Site 12119, Boston
Teva Investigational Site 12182, South Dartmouth
MichiganTeva Investigational Site 12187, Brighton
MissouriTeva Investigational Site 12149, Columbia
Teva Investigational Site 12089, St Louis
Teva Investigational Site 12108, St Louis
NebraskaTeva Investigational Site 12158, Hastings
NevadaTeva Investigational Site 12150, Las Vegas
Teva Investigational Site 12160, Las Vegas
New JerseyTeva Investigational Site 12110, Jersey City
North CarolinaTeva Investigational Site 12115, Charlotte
Teva Investigational Site 12185, High Point
Teva Investigational Site 12085, Raleigh
OklahomaTeva Investigational Site 12178, Oklahoma City
Teva Investigational Site 12155, Tulsa
Teva Investigational Site 12170, Tulsa
PennsylvaniaTeva Investigational Site 12072, Philadelphia
Teva Investigational Site 12114, Pittsburgh
South CarolinaTeva Investigational Site 12107, Rock Hill
TexasTeva Investigational Site 12060, Austin
Teva Investigational Site 12083, Austin
Teva Investigational Site 12179, Cypress
Teva Investigational Site 12090, Dallas
Teva Investigational Site 12159, Dallas
Teva Investigational Site 12171, Dallas
Teva Investigational Site 12143, El Paso
Teva Investigational Site 12168, Houston
Teva Investigational Site 12181, Houston
Teva Investigational Site 12184, Houston
Teva Investigational Site 12176, Kerrville
Teva Investigational Site 12096, McKinney
Teva Investigational Site 12113, Mesquite
Teva Investigational Site 12166, Sugar Land
Teva Investigational Site 12183, Tomball
Teva Investigational Site 12084, Victoria
UtahTeva Investigational Site 12148, Pleasant View
Teva Investigational Site 12153, South Ogden
WisconsinTeva Investigational Site 12062, Greenfield

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.