Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Teva Branded Pharmaceutical Products R&D, Inc.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent/assent
General good health
Persistent asthma, with an FEV1 50-80% predicted.
Ability to perform spirometry in an acceptable manner as per protocol guidelines.
Ability to perform PEFR with a handheld peak flow meter.
Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1.
Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit.
Non-smokers.
Capable of understanding the requirements, risks, and benefits of study participation.
You may not be if
Participation in any investigational drug trial within the 30 days preceding the Screening Visit (SV).
A known hypersensitivity to albuterol or any of the excipients in the formulations.
History of severe milk protein allergy.
History of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the Screening Visit (SV).
Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents.
History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV).
Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including.
Clareo Health | A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma
