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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug785 | COVID 19 Diagnostic Test Wiki | 0.58 |
drug56 | 2D Telemedicine Wiki | 0.41 |
drug65 | 3D Telemedicine Wiki | 0.33 |
Name (Synonyms) | Correlation | |
---|---|---|
D029481 | Bronchitis, Chronic NIH | 0.41 |
D001991 | Bronchitis NIH | 0.41 |
D003928 | Diabetic Nephropathies NIH | 0.41 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0004469 | Chronic bronchitis HPO | 0.41 |
HP:0012387 | Bronchitis HPO | 0.41 |
HP:0002099 | Asthma HPO | 0.15 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0000077 | Abnormality of the kidney HPO | 0.14 |
HP:0006536 | Pulmonary obstruction HPO | 0.14 |
HP:0006510 | Chronic pulmonary obstruction HPO | 0.13 |
HP:0002088 | Abnormal lung morphology HPO | 0.10 |
Navigate: Correlations HPO
There are 3 clinical trials
A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease
Description: Change compared to placebo
Measure: Urine albumin:creatinine ratio (UACR) Time: Baseline to Day 169 (24 weeks)Description: To assess the number Treatment Emergent Adverse events (TEAEs), Serious Adverse Events (SAEs), Treatment Emergent Adverse Events of Special Interest (AESIs)
Measure: Safety and Tolerability by assessment of adverse events Time: Visit 1 (Screening) to Day 230 (End of Study)Description: MEDI3506 serum PK concentrations throughout the study
Measure: PK profile of MEDI3506 Time: Day 1 to Day 230Description: Anti-drug antibodies (ADAs) incidence throughout the study
Measure: Immunogenicity of MEDI3506 Time: Day 1 to Day 230Description: Proportion of subjects with > 30%, 40% or 50% reduction
Measure: UACR Time: At Day 169, baseline to Day 85 (12 weeks) or Day 85 to Day 169Description: To assess systolic and diastolic blood pressure, heart rate, respiratory rate, temperature, 12-lead electrocardiogram, echocardiogram and physical exam
Measure: Safety and tolerability by assessment of vital signs Time: Visit 1(Screening) to End of studyDescription: To assess hematology, serum chemistry, urinalysis
Measure: Safety and tolerability by clinical laboratory evaluations Time: Visit 1(Screening) to End of studyStudy D9181C00001 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of MEDI3506 in adult participants with uncontrolled moderate to severe asthma on standard of care (SOC). Up to approximately 80 sites globally will participate in this study. Approximately 228 participants will be randomized to 3 treatment groups in a 1:1:1 ratio to receive MEDI3506 dose 1, MEDI3506 dose 2, or placebo.
Description: To assess the effect of MEDI3506 compared with placebo on lung function, in adult participants with uncontrolled moderate-to-severe asthma.
Measure: Change from baseline to Week 16 in pre-BD FEV1 (L) Time: From Baseline to Week 16Description: To assess the PK of MEDI3506 in adult participants with uncontrolled moderate-to-severe asthma
Measure: Serum MEDI3506 concentration-time profiles from Study Day 1 until Study Day 169 Time: from Study Day 1 to Study Day 169 for a total of 24 weeksDescription: To assess the immunogenicity of MEDI3506 in adult participants with uncontrolled moderate-to-severe asthma.
Measure: ADA during the intervention and follow-up periods Time: from Study Day 1 to Study Day 169 for a total of 24 weeksDescription: To assess the effect of MEDI3506 compared with placebo on asthma control in adult participants with uncontrolled moderate-to-severe asthma.
Measure: Change from baseline to Week 16 in ACQ-6 score. Time: Baseline to Week 16Description: To assess the effect of MEDI3506 compared with placebo on asthma control in adult participants with uncontrolled moderate-to-severe
Measure: Proportion of participants with a decrease in ACQ-6 score of ≥ 0.5 from baseline to Week 16 Time: Baseline to Week 16Description: To assess the effect of MEDI3506 compared with placebo on asthma control in adult participants with uncontrolled moderate-to-severe
Measure: Proportion of participants achieving ACQ-6 well controlled status (defined as ACQ-6 score ≤ 0.75 at Week 16) Time: Week 16Description: To assess the effect of MEDI3506 compared with placebo on health status in adult participants with uncontrolled moderate-to-severe asthma.
Measure: Change from baseline in SGRQ at Week 16 Time: Baseline to Week 16Description: To assess the effect of MEDI3506 compared with placebo on health status in adult participants with uncontrolled moderate-to-severe asthma.
Measure: Proportion of participants with a decrease in SGRQ total score of ≥ 4 points from baseline to Week 16. Time: Baseline to Week 16Description: To further assess the effect of MEDI3506 compared with placebo on lung function, in adult participants with uncontrolled moderate-to-severe asthma
Measure: Change from baseline to Weeks 8 and 16 in post-BD FEV1 (L) Time: From baseline to Weeks 8 and 16Description: To assess the effect of MEDI3506 compared with placebo on CompEx in adult participants with uncontrolled moderate-to-severe asthma
Measure: Time to first CompEx event based on the period from baseline to Week 16 Time: Baseline to Week 16Description: To assess the effect of MEDI3506 compared with placebo on CompEx in adult participants with uncontrolled moderate-to-severe asthma.
Measure: Annualised CompEx event rate Time: Baseline to Week 16Description: To assess the effect of MEDI3506 compared with placebo on concentration of FeNO in adult participants with uncontrolled moderate-to-severe asthma
Measure: Percent change from baseline to Week 16 in concentration of FeNO in exhaled breath Time: From baseline to Week 16This 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