Multiple Ascending Dose Study of TRN-157 in Stable Mild and Moderate Asthmatics

Exclusion Criteria

• •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:
• •* Long-acting muscarinic receptor antagonist (LAMA)
• •* LABA (but may be withdrawn and converted to SABA x 7 days prior to entry)
• •* Leukotriene pathway blockers
• •* Anti-IgE antibody (Xolair) within last 6 months prior to CV1
• •* Phosphodiesterase 4 (PDE4) inhibitors (e.g., Roflumilast)
• •* Cromolyn
• •* Methylxanthines (e.g., aminophylline and theophylline)
• •* 5-Lipoxygenase inhibitor (e.g., Zileuton)
• •Allergies to LAMA therapies
• •History of life-threatening asthma exacerbation requiring ICU admission, mechanical ventilation, or tracheostomy