Overview
Multiple Ascending Dose Study of TRN-157 in Stable Mild and Moderate Asthmatics
Status:
Completed
Completed
Trial end date:
2016-03-01
2016-03-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This multiple ascending dose study is to determine the safety and bronchodilator activity of TRN-157 in 59 mild and moderate asthmatics.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Theron Pharmaceuticals, Inc.Treatments:
Tiotropium Bromide
Criteria
Inclusion Criteria: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
Exclusion Criteria:
A patient meeting any of the following criteria is not eligible for enrollment in the
study:
- 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