A Phase 2a Study to Assess Safety, Daily Symptoms, PK, and Biomarkers of YPL-001 in COPD Patients
NCT ID: NCT02272634
Last Updated: 2023-07-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2015-06-04
2017-11-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
12 / 48 Week Pivotal PFT vs PBO in COPD I
NCT00782210
NVA237 Versus Placebo 12-week Efficacy Study
NCT01709864
A Phase IIa Study to Investigate the Efficacy and Safety of AZD7624 in Chronic Obstructive Pulmonary Disease (COPD) Patients While on Maintenance Therapy
NCT02238483
Study Evaluating 5 Doses of RPL554 and Placebo in COPD Patients Via a Dry Powder Inhaler
NCT04027439
Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD
NCT02343458
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Treatment A: Multiple oral YPL-001 80 mg doses (1 x 80 mg tablet + 1 x 1 YPL-001 80 mg matching placebo tablet) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. Only the morning dose will be administered on Day 56.
Treatment B: Multiple oral YPL-001 160 mg doses (2 x 80 mg tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. Only the morning dose will be administered on Day 56.
Treatment C: Multiple oral matching placebo (2 x 1 YPL-001 80 mg matching placebo tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. Only the morning dose will be administered on Day 56. In all treatments, one tiotropium (Spiriva® HandiHaler®) 18 μg capsule will also be administered QD every morning prior to study drugs administration. Albuterol will be administered on an as needed basis. Each dose of Treatments A, B and C will be administered orally with approximately 240 mL of water.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment A
Multiple oral YPL-001 80 mg doses (1 x 80 mg tablet + 1 x 1 YPL-001 80 mg matching placebo tablet) are administered approximately every 12 hours under fasting conditions for 55 consecutive days.
YPL-001 80 mg
twice daily \[BID\]
Treatment B
Multiple oral YPL-001 160 mg doses (2 x 80 mg tablets) are administered approximately every 12 hours under fasting conditions for 55 consecutive days.
YPL-001 160 mg
twice daily \[BID\]
Treatment C
Multiple oral matching placebo (2 x 1 YPL-001 80 mg matching placebo tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days.
Placebo
twice daily \[BID\]
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
YPL-001 80 mg
twice daily \[BID\]
YPL-001 160 mg
twice daily \[BID\]
Placebo
twice daily \[BID\]
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* History of COPD for at least 12 months prior to screening.
* Diagnosed with COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD for at least 12 months prior to screening.
* Classified as moderate to severe COPD based on the current severity classification GOLD Stage 2-3 disease in terms of post-bronchodilator spirometry at screening
* etc.
Exclusion Criteria
* History of more than 2 hospitalizations for COPD within 12 months prior to screening.
* Presentation of an acute exacerbation of COPD that will be associated with increase sputum volume or change in sputum color within 4 weeks before Day 1 of the Run-in Period.
* Evidence of pulmonary heart disease, or clinically significant pulmonary hypertension.
* etc.
30 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yungjin Pharm. Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gerard J Criner, MD
Role: PRINCIPAL_INVESTIGATOR
Temple University
Mark T Dransfield, MD
Role: PRINCIPAL_INVESTIGATOR
The Kirklin Clinic of UAB Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UAB Lung Health Center
Birmingham, Alabama, United States
Florida Pulmonary Research Institute, LLC
Winter Park, Florida, United States
Aventiv Research Inc.
Columbus, Ohio, United States
Temple Lung Center, Temple University Hospital
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lee KH, Woo J, Kim J, Lee CH, Yoo CG. YPL-001 Shows Various Beneficial Effects against Cigarette Smoke Extract-Induced Emphysema Formation: Anti-Inflammatory, Anti-Oxidative, and Anti-Apoptotic Effects. Antioxidants (Basel). 2022 Dec 22;12(1):15. doi: 10.3390/antiox12010015.
Lee SU, Lee S, Ro H, Choi JH, Ryu HW, Kim MO, Yuk HJ, Lee J, Hong ST, Oh SR. Piscroside C inhibits TNF-alpha/NF-kappaB pathway by the suppression of PKCdelta activity for TNF-RSC formation in human airway epithelial cells. Phytomedicine. 2018 Feb 1;40:148-157. doi: 10.1016/j.phymed.2018.01.012. Epub 2018 Jan 31.
Ryu HW, Lee SU, Lee S, Song HH, Son TH, Kim YU, Yuk HJ, Ro H, Lee CK, Hong ST, Oh SR. 3-Methoxy-catalposide inhibits inflammatory effects in lipopolysaccharide-stimulated RAW264.7 macrophages. Cytokine. 2017 Mar;91:57-64. doi: 10.1016/j.cyto.2016.12.006. Epub 2016 Dec 21.
Lee SU, Sung MH, Ryu HW, Lee J, Kim HS, In HJ, Ahn KS, Lee HJ, Lee HK, Shin DH, Lee Y, Hong ST, Oh SR. Verproside inhibits TNF-alpha-induced MUC5AC expression through suppression of the TNF-alpha/NF-kappaB pathway in human airway epithelial cells. Cytokine. 2016 Jan;77:168-75. doi: 10.1016/j.cyto.2015.08.262. Epub 2015 Aug 28.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YPL-001_YJP-130403
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.