Last updated 7 days ago
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
2196 patients around the world
Available in Argentina
Teva Branded Pharmaceutical Products R&D, Inc.
1Research sites
2196Patients around the world
This study is for people with
Asthma
Requirements for the patient
From 4 Years
All Gender
Medical requirements
- The participant has a diagnosis of asthma for at least 1 year according to the 2022 GINA guidelines.The participant has a documented history of at least 1 severe clinical asthma exacerbation (CAE) within the past 12 months before screening.The participant is using any prescribed inhaled asthma controller medication at a stable dose for 1 month prior to the screening visit.If female, the 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 study, or is of nonchildbearing potential.
- The participant has life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years before screening.The participant has a suspected bacterial or viral infection other than Coronavirus Disease COVID-19 of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the screening period.Participants with a confirmed infection with COVID-19 within 6 weeks prior to the screening visit, or with residual COVID-19 symptoms long COVID-19.The participant has had a clinical asthma exacerbation (CAE) requiring systemic corticosteroids within 30 days before screening, or any hospitalization for asthma within 2 months before screening.The participant is a current tobacco smoker or has a smoking history of ≥10 pack-years, or the participant used tobacco within the past 6 months.The participant has significantly abused alcohol and/or prohibited drugs within the previous 24 months.The participant has participated as a randomized participant in any investigational drug study within 30 days.The participant has been hospitalized for psychiatric disorder or attempted suicide within 1 year of screening.
Sites
Centro Integral de Medicina Respiratoria (CIMER) - Tucumán
Recruiting
StudyFLAIR
SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Conditions
Asthma
Requirements
From 4 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06052267
