Phase 2
Completed N=61
A Phase 2a Study to Assess Safety, Daily Symptoms, PK, and Biomarkers of YPL-001 in COPD Patients
Source: ClinicalTrials.gov NCT02272634 ↗Enrolled (actual)
61
Serious AEs
1.6%
Results posted
Jun 2021
Primary outcomePrimary: Treatment-Emergent Adverse Event Frequency by Treatment - Number of Patients Reporting Events — 10; 8; 14; 10 Participants
Summary
This is a Phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy, 3-treatment, parallel study, with low and high YPL 001 doses (low dose and high dose twice daily [BID]) and a placebo control in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-Emergent Adverse Event Frequency by Treatment - Number of Patients Reporting Events |
10; 8; 14; 10; 13; 6 | — |
| PRIMARY Treatment-Emergent Adverse Event Frequency by Treatment - Adverse Events |
18; 14; 23; 1; 1; 0 | — |
| PRIMARY Treatment-Emergent Adverse Event Frequency by Treatment, Severity, and Relationship to Drug - Number of Patients Reporting Events |
10; 8; 14; 3; 3; 4 | — |
| PRIMARY Treatment-Emergent Adverse Event Frequency by Treatment, Severity, and Relationship to Drug - Adverse Events |
18; 14; 23; 9; 8; 11 | — |
| SECONDARY Change From Baseline in Main Peak Expiratory Flow (PEF) Measured Daily |
250.0; 254.9; 240.7; 282.8; 277.9; 247.6 | — |
| SECONDARY Change From Baseline of Symptom Severity Score for Symptoms of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
0.63; 0.17; 0.47; 0.26; 0.18; 0.50 | — |
| SECONDARY Change From Baseline in Dyspnea (Modified Borg Dyspnea Scale) |
3.88; 4.05; 3.18; 3.76; 3.88; 3.31 | — |
| SECONDARY Change From Baseline of Calculated Score From Duke Activity Status Index (DASI) |
-0.267; -2.844; 1.137 | — |
Eligibility Criteria
Inclusion Criteria
- Adult males and/or females, 30 to 85 years of age (inclusive).
- 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 life-threatening COPD including respiratory arrest, intensive care unit admission and/or requiring intubation.
- 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.
Data sourced from ClinicalTrials.gov (NCT02272634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.