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
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Generally healthy, male and female adults aged 18 to 55 years at Screening.
2. Clinical diagnosis of intermittent, or mild-to-moderate persistent, asthma for at least 6 months before Screening, and having used inhaled epinephrine or β-agonist(s) for asthma control;
3. Demonstrating a baseline forced expiratory volume in 1 second (FEV1) at 50-90 percent of predicted normal at Screening;
4. Demonstrating a 12.0 percent or greater airway reversibility in FEV1 within 30 min after inhaling 2 actuations of Epinephrine CFC-MDI (440 mcg Epinephrine base) at Screening;
5. Females of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
6. Demonstration of proficiency in the use of a MDI inhaler after training;
7. Having properly consented to participate in the trial.
You may not be if
1. A smoking history of 10 or more pack-years, or having smoked within 6 months prior to Screening;
2. Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk, prior to Screening;
3. Asthma exacerbations that required emergency care or hospitalized treatment, within 4 wk prior to Screening;
4. Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases besides asthma;
5. Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine (including diabetes), psychiatric, neoplastic or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study;
6. Known intolerance or hypersensitivity to any of the study MDI ingredients (i.e., Epinephrine, HFA-134a, CFC-12, CFC-114, polysorbate-80, ethanol, thymol, nitric acid and ascorbic acid);
7. Use of prohibited drugs or failure to observe the drug washout restrictions;
8. Having been on other investigational drug/device studies in the last 30 days prior to Screening.
Clareo Health | Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients.
