Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Theron Pharmaceuticals, Inc.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients who meet the following criteria will be considered eligible to participate in the study:
The patient is ≥ 18 and \< 70 years of age, and gives informed consent
Clinical diagnosis of mild to moderate asthma of at least 6 months duration and age of onset \< 50 years
Presently using ICS at moderate doses (equivalent to 200-800 µg of budesonide or 88-500 µg of fluticasone daily)
≥ 12% and ≥ 200 mL improvement in FEV1 to 4 puffs albuterol by metered-dose inhaler (MDI) at screening visit
Patient is willing to use acceptable form of birth control during trial and for one month thereafter
Ability to measure morning (AM) peak expiratory flow (PEF) on schedule using electronic peak flow meter (EPFM) and to complete the study diary correctly at least 70% of the time during the run-in period
After 7 day withdrawal from LABA therapy and overnight withdrawal from SABA therapy (except rescue medication), patient has between 55% - 80% of predicted FEV1 at CV2
You may not be if
A clinical diagnosis of chronic obstructive pulmonary disease (COPD), chronic bronchitis, bronchiectasis, or other significant pulmonary disease other than asthma
History of upper or lower respiratory infection within 4 weeks of screening
History of asthma exacerbation requiring oral or systemic corticosteroids or hospital admission within 6 months of screening
History of myocardial infarction, or cardiac conduction abnormalities, including but not limited to atrial fibrillation, and paroxysmal atrial tachycardia
Hospitalization due to cardiac failure within the last 6 months
History of narrow angle glaucoma or obstructive uropathy
Current smokers or vapers, or former smokers with \> 10 pack-year (self-reported) history of smoking
Patients who presently use the following medications will not be eligible for participation:
