NCT06664619 · Teva Branded Pharmaceutical Products R&D, Inc.
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
What this study is about
The primary objective of the trial is to evaluate the effectiveness of fluticasone propionate/albuterol sulfate multidose dry powder inhaler with electronic module (Fp/ABS eMDPI).
View original scientific description
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).
Interventions
DRUG
Fp/ABS
Inhalation powder
DRUG
FP
Inhalation powder
DRUG
ABS
Inhalation powder
DRUG
Placebo
Inhalation powder
Primary outcome measures
Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks
Time frame: Baseline, 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 4
Time frame: Baseline, Week 4
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Encinitas, California
- Huntington Beach, California
- La Palma, California
- Laguna Niguel, California
- Long Beach, California
- Los Angeles, California
- Northridge, California
- Oxnard, California
- Sacramento, California
And 62 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations