Multiple Ascending Dose Study of TRN-157 in Stable Mild and Moderate Asthmatics
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Two-Way Cross-Over, Phase 2a Study to Evaluate the Safety and Bronchodilator Activity of TRN-157 in Stable Mild and Moderate Asthmatics
1 other identifier
interventional
59
1 country
7
Brief Summary
This multiple ascending dose study is to determine the safety and bronchodilator activity of TRN-157 in 59 mild and moderate asthmatics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 asthma
Started Apr 2015
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMay 9, 2017
May 1, 2017
11 months
February 17, 2015
May 8, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in FEV1
After 2 weeks of treatment with TRN-157 vs. Placebo
Safety and tolerability as determined by number of subjects with adverse events
Adverse events and/or clinically significant changes in vital signs, ECG, and/or laboratory values
After 2 weeks of treatment with TRN-157 vs. Placebo
Secondary Outcomes (3)
Characterize effects on pulmonary function
After 2 weeks of treatment with TRN-157 vs. Placebo
Characterize effects on asthma symptomatology
During the 2 weeks of treatment with TRN-157 vs. Placebo
Determination of pharmacokinetic parameters: AUC0-t, AUC0-inf, Cmax, tmax, t½, elimination rate constant (kel), volume of distribution at steady state (Vss/F), total plasma clearance (CL/F)
After 2 weeks of treatment with TRN-157
Study Arms (3)
TRN-157
EXPERIMENTALPlacebo
PLACEBO COMPARATORTiotropium
ACTIVE COMPARATORInterventions
Eligibility Criteria
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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
WCCT Global
Costa Mesa, California, United States
Allied Clinical Research
Gold River, California, 95670, United States
Allied Clinical Research
Reno, Nevada, 89503, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kenneth Krantz, MD, PhD
Theron Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2015
First Posted
March 6, 2015
Study Start
April 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
May 9, 2017
Record last verified: 2017-05