Multiple Ascending Dose Study of TRN-157 in Stable Mild and Moderate Asthmatics
Completed · Phase 2 · Has a placebo group
Conditions studied: Asthma
In brief
This multiple ascending dose study is to determine the safety and bronchodilator activity of TRN-157 in 59 mild and moderate asthmatics.
Key facts
- Study ID
- NCT02382510
- Run by
- Theron Pharmaceuticals, Inc.
- People needed
- 59
- Starts
- 2015-04-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2017-05-09
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify if…
- 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
Where it is running
- WCCT Global — Costa Mesa, California, United States
- Allied Clinical Research — Gold River, California, United States
- Allied Clinical Research — Reno, Nevada, United States
- Dr. Winder & Associates/Toledo Center for Clinical Research — Sylvania, Ohio, United States
- The Allergy and Asthma Center of Southern Oregon — Medford, Oregon, United States
- West Houston Clinical Research Services — Houston, Texas, United States
- Sylvana Research — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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