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

Launched by TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. · Oct 28, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new inhaler that combines two medications, fluticasone propionate and albuterol sulfate, to see how well it works and how safe it is for people aged 12 and older with asthma. The inhaler is designed to be used four times a day, and researchers want to find out if it helps control asthma symptoms better than a placebo (a treatment that doesn't contain any active medication). The study will last about 10 weeks for each participant, and during this time, they will be monitored for both the effectiveness of the inhaler and any side effects.

To participate, you must have been diagnosed with asthma for at least six months and currently use a rescue inhaler, like albuterol, for your symptoms. It's important that you haven't had any serious asthma episodes recently or any respiratory infections in the last two weeks. If you're interested in joining the study or want to know more, please reach out to the study team for additional details. This trial could help improve asthma management for many patients, so your participation could make a difference!

Gender

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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