Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug56 | 2D Telemedicine Wiki | 1.00 |
| drug65 | 3D Telemedicine Wiki | 0.82 |
| drug2046 | ION-827359 Wiki | 0.71 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D029481 | Bronchitis, Chronic NIH | 1.00 |
| D001991 | Bronchitis NIH | 1.00 |
| D000208 | Acute Disease NIH | 0.71 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0004469 | Chronic bronchitis HPO | 1.00 |
| HP:0006536 | Pulmonary obstruction HPO | 0.33 |
| HP:0006510 | Chronic pulmonary obstruction HPO | 0.32 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002088 | Abnormal lung morphology HPO | 0.25 |
Navigate: Correlations HPO
There are 2 clinical trials
The purpose of this study is to evaluate the effect of ION-827359 on forced expiratory volume in 1 second (FEV1) in patients with mild to moderate COPD with CB.
Description: The EXACT (E-RS) scale is a participant-reported outcome (PRO) designed to measure the symptoms of participants with COPD. The E-RS utilizes 11 respiratory symptom items from the existing and validated 14-item EXACT, which measures symptoms of exacerbation. The E-RS total score quantifies respiratory symptom severity, and 3 domains assess breathlessness, cough and sputum, and chest symptoms. The E-RS will be collected on the daily e-diary, which will include all 14 items from the EXACT questionnaire.
Measure: Change From Baseline in the EXACT Respiratory Symptoms (E-RS) Daily Symptom Diary to the Primary Time Point Time: One week prior to first dose through one week after the last dose.Description: The CAT is an eight-item questionnaire that will be completed by the participant and is designed to quantify the impact of COPD symptoms on the health status of participants. The CAT provides a score of 0-40 to indicate the impact of the disease.
Measure: Change From Baseline in the COPD Assessment Test (CAT) to the Week 14 Time Point Time: From Baseline up to Week 14Description: The SGRQ is a participant completed, a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airway disease. Scores of the SGRQ-C range from 0 to 100, with higher scores indicating more limitations.
Measure: Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) to the Week 14 Time Point Time: From Baseline up to Week 14This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Chronic Obstructive Pulmonary Disease and Chronic Bonchitis.
Description: To assess the effects of MEDI3506 compared with placebo on pulmonary function in participants with COPD and chronic bronchitis.
Measure: Change from baseline to Week 12 in pre-bronchdilator forced expiratory volume in 1 second (FEV1) measured in clinic. Time: From Baseline to Week 12Description: To assess the PK of MEDI3506 in participants with COPD and chronic bronchitis.
Measure: Area under the PK concentration- time curve, during the intervention and follow up periods. Time: From Study Day 1 to Week 36Description: To assess the PK of MEDI3506 in participants with COPD and chronic bronchitis.
Measure: Peak plasma concentration (Cmax) profile during the intervention and follow up periods Time: From Study Day 1 to Week 36Description: To assess the immunogenicity of MEDI3506 compared with placebo in participants with COPD and chronic bronchitis.
Measure: Anti-drug antibodies during the intervention and follow-up periods. Time: From Study Day 1 to Week 36Description: To assess the effect of MEDI3506 on COPDCompEx event in participants with COPD and chronic bronchitis
Measure: Time to first COPDCompEx event based on the period from baseline to 4 weeks after last dose (Week 28) Time: From Baseline to Week 28Description: To assess the effect of MEDI3506 compared with placebo on respiratory symptoms in participants with COPD and chronic bronchitis. Higher score indicates worse outcome. Min Score = 0 Max Score= 40
Measure: Change from baseline to Week 12 in E-RS:COPD Time: From Baseline to Week 12Description: To assess the effect of MEDI3506 compared with placebo on respiratory symptoms in participants with COPD and chronic bronchitis. Higher score indicates worse outcome. Min Score= 0 Max Score=12
Measure: Change from baseline to Week 12 in Mean Breathless, cough and sputum scale (BCSS) Score Time: From Baseline to Week 12Description: To assess the effect of MEDI3506 compared with placebo on respiratory symptoms in participants with COPD and chronic bronchitis. Higher score indicates worse outcome. Min Score= 0 Max Score=100
Measure: Change from baseline to Week 12 in Cough Visual Analogue Scale (VAS) item Time: From Baseline to Week 12Description: To assess the effect of MEDI3506 compared with placebo on disease impact in participants with COPD and chronic bronchitis. Higher score indicates worse outcome. Min Score= 0 Max Score=100
Measure: Change from baseline to Week 12 in St Georges Respiratory Questionnaire (SGRQ) total score Time: From Baseline to Week 12Description: To assess the effect of MEDI3506 compared with placebo on disease impact in participants with COPD and chronic bronchitis. Responder endpoint 'yes' and 'no'. 'No' is the worse outcome.
Measure: Proportion of participants with a decrease in St Georges Respiratory Questionnaire (SGRQ) total score of ≥ 4 points from baseline to Week 12 Time: From Baseline to Week 12Description: To assess the effect of MEDI3506 compared with placebo on airway resistance and reactance in participants with COPD and chronic bronchitis.
Measure: Change from baseline to Week 12 in Airway Oscillometry parameter difference between R5 and R20 (R5-R20) Time: From Baseline to Week 12Description: To assess the effect of MEDI3506 compared with placebo on airway resistance and reactance in participants with COPD and chronic bronchitis.
Measure: Change from baseline to Week 12 in Airway Oscillometry parameter Area under Reactance Curve (AX). Time: From Baseline to Week 12Description: To assess the effect of MEDI3506 compared with placebo on airway resistance and reactance in participants with COPD and chronic bronchitis.
Measure: Change from baseline to Week 12 in Airway Oscillometry parameter resistance at 20Hz (R20) . Time: From Baseline to Week 12Description: To assess the effect of MEDI3506 compared with placebo on airway resistance and reactance in participants with COPD and chronic bronchitis.
Measure: Change from baseline to Week 12 in Airway Oscillometry parameter resistance at 5Hz (R5) Time: From Baseline to Week 12Description: To evaluate the effect of MEDI3506 compared with placebo on objective cough measures in participants with COPD and chronic bronchitis.
Measure: At Week 12, ratio to baseline in: Daily (ie, 24 hour) cough frequency, Night time cough frequency, Awake time cough frequency Time: Week 12Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports