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Asthma Study: Fluticasone Propionate/Albuterol Sulfate Combination Inhaler

This study is testing a new combination inhaler called fluticasone propionate/albuterol sulfate (Fp/ABS) for people aged 12 and older with asthma. We want to see how well this inhaler works to improve breathing and if it's safe to use. You might be able to join if you've had asthma for at least 6 months and currently use a rescue inhaler like albuterol. The main goal is to measure changes in your lung function (how much air you can breathe out in one second, called FEV1) over 4 weeks. The study is planned to include 724 participants. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either the study inhaler, its individual components, or a placebo, without knowing which one they are getting. It aims to enroll 724 participants.
What's involved
Your participation in this study would last approximately 10 weeks, not including an optional prescreening visit.
Compensation
Not stated in the trial record.
Follow-up
Your lung function will be measured at the beginning of the study and again at Week 4.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06664619

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

Recruiting
PHASE3Ages 12+InterventionalTreatment
Teva Branded Pharmaceutical Products R&D LLC
~724 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Fp/ABSFPABSPlacebo

At a glance

Recruiting sites
155 of 183 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks
Measured over Baseline, Week 4
+1 more outcome measured

Conditions

Asthma

Explore related trials

Asthma

Where it's being run

183 sites across 39 states
Texas16
Argentina16
Germany16
California14
Bulgaria14
Florida13
Poland9
Serbia9

Study leadership

  • Teva Medical Expert, MD · STUDY_DIRECTOR · Teva Branded Pharmaceutical Products R&D LLC

Who to contact

Teva U.S. Medical Information
[email protected]
1-888-483-8279
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeksBaseline, Week 4

    Baseline values are averaged on day 1 to get a single value. Area under the effect curve will be calculated using measurements collected between zero and 6 hours after dosing. Baseline-adjusted post-dose FEV1 AUEC0-6h for visits on Day 1 and at Week 4 will be calculated using the trapezoidal rule.

  • Change from Baseline trough FEV1 at week 4Baseline, Week 4