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
At least 12 years of age at screening
General good health
Persistent asthma for ≥3 months, with an FEV1 50-80% predicted and ≥15% reversibility
Taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of fluticasone propionate/day) for at least 4 weeks prior to the Screening Visit.
Ability to perform spirometry in an acceptable manner as per protocol guidelines
You may not be if
A known hypersensitivity to albuterol or any of the excipients in the formulations.
History of a respiratory infection or disorder that has not resolved within 1 week preceding the Screening Visit (SV).
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 SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.
Hospitalization due to asthma exacerbation 2 or more times in the past year
Initiation of immunotherapy or dose escalation during the study period
