AsthmaPhase 2NCT02382510
Multiple Ascending Dose Study of TRN-157 in Stable Mild and Moderate Asthmatics
A Phase 2 study testing TRN-157 and Tiotropium in people with Asthma, run by Theron Pharmaceuticals, Inc. at 7 sites in United States.
Trial summary
This multiple ascending dose study is to determine the safety and bronchodilator activity of TRN-157 in 59 mild and moderate asthmatics. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- TRN-157 and Tiotropium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2015to Mar 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
WCCT Global
Costa Mesa, California
Allied Clinical Research
Gold River, California, 95670
West Houston Clinical Research Services
Houston, Texas
The Allergy and Asthma Center of Southern Oregon
Medford, Oregon
Allied Clinical Research
Reno, Nevada, 89503
Sylvana Research
San Antonio, Texas
Dr. Winder & Associates/Toledo Center for Clinical Research
Sylvania, Ohio
About this study
Official title: 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
This multiple ascending dose study is to determine the safety and bronchodilator activity of TRN-157 in 59 mild and moderate asthmatics.
- Conditions
- Asthma
- Being tested
- TRN-157, Placebo, Tiotropium
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRN-157Drug
PlaceboOther
TiotropiumDrug
| Study group | Role | What they receive |
|---|---|---|
| TRN-157 | Experimental | Not described Receives: Drug: TRN-157 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| Tiotropium | Active comparator | Not described Receives: Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in FEV1
Measured: 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
Measured: After 2 weeks of treatment with TRN-157 vs. Placebo
Secondary outcomes (3)
Characterize effects on pulmonary function
FEV1(0-4 h); FVC AUC(0-4 h); FVC(0-4 h); Morning PEFR; Trough (pre-dose) FEV1
Measured: After 2 weeks of treatment with TRN-157 vs. Placebo
Characterize effects on asthma symptomatology
Asthma symptoms, including exacerbations; Number of asthma-control days; Rescue inhaler use; Nocturnal symptoms
Measured: 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)
AUC0-t, AUC0-inf, Cmax, tmax, t½, elimination rate constant (kel), volume of distribution at steady state (Vss/F), total plasma clearance (CL/F)
Measured: After 2 weeks of treatment with TRN-157
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theron Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Krantz, MD, PhD, Study director, Theron Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02382510
- Sponsor's protocol ID
- TRN-157-102
- Status last verified
- May 2017
- First submitted
- 17 Feb 2015
- Last updated
- 9 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02382510
- Acronym / sponsor ID
- TRN-157-102
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Theron Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multiple ascending dose study is to determine the safety and bronchodilator activity of TRN-157 in 59 mild and moderate asthmatics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRN-157 | Experimental | Drug: TRN-157 |
| Placebo | Placebo comparator | Other: Placebo |
| Tiotropium | Active comparator | Drug: Tiotropium |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRN-157 | Drug | TRN-157 |
| Placebo | Other | Placebo |
| Tiotropium | Drug | Tiotropium |
Primary outcome
Change from baseline in FEV1
Time frame: After 2 weeks of treatment with TRN-157 vs. Placebo
Safety and tolerability as determined by number of subjects with adverse events
Time frame: After 2 weeks of treatment with TRN-157 vs. Placebo
Adverse events and/or clinically significant changes in vital signs, ECG, and/or laboratory values
3 secondary outcomes
Characterize effects on pulmonary function
Time frame: After 2 weeks of treatment with TRN-157 vs. Placebo
Characterize effects on asthma symptomatology
Time frame: 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)
Time frame: After 2 weeks of treatment with TRN-157
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
Related trials for Asthma
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Asthma
RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
Asthma
Not yet recruitingPhase 4
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Krantz, MD, PhD study director
Theron Pharmaceuticals, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRN-157 and Tiotropium in people with Asthma, run by Theron Pharmaceuticals, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in FEV1 (time frame: After 2 weeks of treatment with TRN-157 vs. Placebo). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.