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 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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

Where this trial is running

• Teva Investigational Site 12087, Phoenix, Arizona, United States
• Teva Investigational Site 12144, Phoenix, Arizona, United States
• Teva Investigational Site 12104, Tucson, Arizona, United States
• Teva Investigational Site 12146, Tucson, Arizona, United States
• Teva Investigational Site 12102, Little Rock, Arkansas, United States
• Teva Investigational Site 12154, Encinitas, California, United States
• Teva Investigational Site 12103, Huntington Beach, California, United States
• Teva Investigational Site 12068, La Palma, California, United States
• Teva Investigational Site 12152, Laguna Niguel, California, United States
• Teva Investigational Site 12145, Long Beach, California, United States
• Teva Investigational Site 12088, Los Angeles, California, United States
• Teva Investigational Site 12094, Los Angeles, California, United States

+ 171 more sites.

Who to contact

Teva U.S. Medical Information · 1-888-483-8279 · USMedInfo@tevapharm.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06664619.