Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amphastar Pharmaceuticals, Inc.
Age
4–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Generally healthy male, and premenarchal female, children aged 4 - 11 years upon Screening.
With documented asthma, requiring inhaled epinephrine or beta2-agonist treatment, with or without concurrent anti-inflammatory therapies for at least 6-months prior to Screening.
Being capable of performing spirometry for FEV1
Satisfying criteria of asthma
Can tolerate withholding treatment with inhaled bronchodilators and other allowed medications for the minimum washout periods
Demonstrating a Screening Baseline FEV1 that is 50 - 90% of Polgar predicted normal value.
Demonstrating an Airway Reversibility,
Demonstrating satisfactory techniques in the use of a metered-dose inhaler (MDIs) and a hand held peak expiratory flow meter, after training.
Has been properly consented to participate in this study.
You may not be if
Any current or past medical conditions that, per investigator discretion, might significantly affect pharmacodynamic responses to the study drugs
