Recruiting

Phase 3

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

Sponsor:

Teva Branded Pharmaceutical Products R&D LLC

Code:

NCT06664619

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Fp/ABS

ABS

Placebo

Study Details

Brief summary:

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.

Conditions

Asthma

Study ID

NCT06664619

Start date

Dec 12, 2024

Status verified date

Aug, 2026

Completion date

Sep 19, 2026

Anticipated

Primary completion date

Sep 19, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

724 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fp/ABS eMDPI

Fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module

active comparator: Fp eMDPI

Fluticasone propionate (Fp) dry powder inhaler with an integrated electronic module (eMDPI)

active comparator: ABS eMDPI

Albuterol sulfate (ABS) dry powder inhaler with an integrated electronic module (eMDPI)

placebo comparator: Placebo eMDPI

Interventions

Fp/ABS

Inhalation powder

ABS

Inhalation powder

Placebo

Inhalation powder

Primary outcome measure

Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks [ Time Frame: Baseline, Week 4 ]
Change from Baseline trough FEV1 at week 4 [ Time Frame: Baseline, Week 4 ]

Central Contacts and Locations

Central contacts

Teva U.S. Medical Information

1-888-483-8279 USMedInfo@tevapharm.com

Locations

Teva Investigational Site 12087

Recruiting

Phoenix, Arizona, United States, 85015

Teva Investigational Site 12146

Recruiting

Tucson, Arizona, United States, 85741

Teva Investigational Site 12102

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Little Rock, Arkansas, United States, 72205

Teva Investigational Site 12154

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Encinitas, California, United States, 92024-2812

Teva Investigational Site 12103

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Huntington Beach, California, United States, 92647

Teva Investigational Site 12068

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La Palma, California, United States, 90623

Teva Investigational Site 12152

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Laguna Niguel, California, United States, 92677

Teva Investigational Site 12145

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Long Beach, California, United States, 90815

Teva Investigational Site 12088

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Los Angeles, California, United States, 90048

Teva Investigational Site 12094

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Los Angeles, California, United States, 93551

Teva Investigational Site 12161

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Northridge, California, United States, 91324

Teva Investigational Site 12105

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Oxnard, California, United States, 93030-5822

Teva Investigational Site 12064

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San Jose, California, United States, 95117

Teva Investigational Site 12142

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Lakewood, Colorado, United States, 80228

Teva Investigational Site 12079

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Melbourne, Florida, United States, 32934

Teva Investigational Site 12071

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Miami, Florida, United States, 33126

Teva Investigational Site 12074

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Miami, Florida, United States, 33135

Teva Investigational Site 12086

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Miami, Florida, United States, 33173

Teva Investigational Site 12097

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Miami, Florida, United States, 33175

Teva Investigational Site 12075

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Pompano Beach, Florida, United States, 33064

Teva Investigational Site 12078

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Tampa, Florida, United States, 33607

Teva Investigational Site 12175

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Conyers, Georgia, United States, 30012

Teva Investigational Site 12156

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Boise, Idaho, United States, 83706

Teva Investigational Site 12162

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Westchester, Illinois, United States, 60154

Teva Investigational Site 12169

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Shreveport, Louisiana, United States, 71105

Teva Investigational Site 12106

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Towson, Maryland, United States, 21204

Teva Investigational Site 12157

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White Marsh, Maryland, United States, 21162-5503

Teva Investigational Site 12119

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Boston, Massachusetts, United States, 02115

Teva Investigational Site 12182

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South Dartmouth, Massachusetts, United States, 02747

Teva Investigational Site 12187

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Brighton, Michigan, United States, 48116

Teva Investigational Site 12149

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Columbia, Missouri, United States, 65203

Teva Investigational Site 12108

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St Louis, Missouri, United States, 63110

Teva Investigational Site 12089

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St Louis, Missouri, United States, 63141

Teva Investigational Site 12158

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Hastings, Nebraska, United States, 68901

Teva Investigational Site 12160

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Las Vegas, Nevada, United States, 89113

Teva Investigational Site 12150

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Las Vegas, Nevada, United States, 89119

Teva Investigational Site 12110

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Jersey City, New Jersey, United States, 07306

Teva Investigational Site 12115

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Charlotte, North Carolina, United States, 28207

Teva Investigational Site 12185

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High Point, North Carolina, United States, 27260

Teva Investigational Site 12085

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Raleigh, North Carolina, United States, 27607-6689

Teva Investigational Site 12178

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Oklahoma City, Oklahoma, United States, 73120

Teva Investigational Site 12155

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Tulsa, Oklahoma, United States, 74133

Teva Investigational Site 12170

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Tulsa, Oklahoma, United States, 74136

Teva Investigational Site 12072

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Philadelphia, Pennsylvania, United States, 19107

Teva Investigational Site 12114

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Pittsburgh, Pennsylvania, United States, 15241

Teva Investigational Site 12107

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Rock Hill, South Carolina, United States, 29732

Teva Investigational Site 12083

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Austin, Texas, United States, 78744

Teva Investigational Site 12060

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Austin, Texas, United States, 78759

Teva Investigational Site 12179

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Cypress, Texas, United States, 77429

Teva Investigational Site 12159

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Dallas, Texas, United States, 75225-6301

Teva Investigational Site 12171

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Dallas, Texas, United States, 75235

Teva Investigational Site 12090

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Dallas, Texas, United States, 75243

Teva Investigational Site 12143

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El Paso, Texas, United States, 79912

Teva Investigational Site 12181

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Houston, Texas, United States, 77008-1528

Teva Investigational Site 12168

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Houston, Texas, United States, 77018

Teva Investigational Site 12184

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Houston, Texas, United States, 77065

Teva Investigational Site 12176

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Kerrville, Texas, United States, 78028

Teva Investigational Site 12096

Recruiting

McKinney, Texas, United States, 75069

Teva Investigational Site 12113

Recruiting

Mesquite, Texas, United States, 75150

Teva Investigational Site 12166

Recruiting

Sugar Land, Texas, United States, 77479

Teva Investigational Site 12183

Recruiting

Tomball, Texas, United States, 77081

Teva Investigational Site 12084

Recruiting

Victoria, Texas, United States, 77901

Teva Investigational Site 12148

Recruiting

Pleasant View, Utah, United States, 84404-4791

Teva Investigational Site 12153

Recruiting

South Ogden, Utah, United States, 84405

Teva Investigational Site 12062

Recruiting

Greenfield, Wisconsin, United States, 53228

More Information

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Teva Branded Pharmaceutical Products R&D LLC on 2026-08-31.