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D029481: Bronchitis, Chronic

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (5)


Name (Synonyms) Correlation
drug56 2D Telemedicine Wiki 1.00
drug65 3D Telemedicine Wiki 0.82
drug2046 ION-827359 Wiki 0.71
Name (Synonyms) Correlation
drug2453 MEDI3506 Wiki 0.41
drug3195 Placebo Wiki 0.06

Correlated MeSH Terms (5)


Name (Synonyms) Correlation
D001991 Bronchitis NIH 1.00
D000208 Acute Disease NIH 0.71
D008173 Lung Diseases, Obstructive NIH 0.33
Name (Synonyms) Correlation
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.32
D008171 Lung Diseases, NIH 0.25

Correlated HPO Terms (5)


Name (Synonyms) Correlation
HP:0004469 Chronic bronchitis HPO 1.00
HP:0012387 Bronchitis HPO 1.00
HP:0006536 Pulmonary obstruction HPO 0.33
Name (Synonyms) Correlation
HP:0006510 Chronic pulmonary obstruction HPO 0.32
HP:0002088 Abnormal lung morphology HPO 0.25

Clinical Trials

Navigate: Correlations   HPO

There are 2 clinical trials


1 A Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Patients With Mild to Moderate COPD With Chronic Bronchitis

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.

NCT04441788
Conditions
  1. Chronic Bronchitis
  2. Chronic Obstructive Pulmonary Disease
Interventions
  1. Drug: ION-827359
  2. Drug: Placebo
MeSH:Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Bronchitis Bronchitis, Chronic Acute Disease
HPO:Abnormal lung morphology Bronchitis Chronic bronchitis Chronic pulmonary obstruction Pulmonary obstruction

Primary Outcomes

Measure: Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo

Time: From Baseline up to average of Weeks 13 and 14

Secondary Outcomes

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 14

Description: 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 14

Measure: Change from Baseline in Post-Bronchodilator FEV1

Time: From Baseline up to average of Weeks 13 and 14

Measure: Cmax: Maximum Observed Plasma Concentration for ION-827359

Time: Up to Week 24

Measure: Tmax: Time to Reach the Maximum Plasma Concentration for ION-827359

Time: Up to Week 24

Measure: AUC[0-t]: Area Under the Plasma Concentration-Time Curve from Time Zero to t for ION-827359

Time: Up to Week 24

Measure: Incidence of Participants With at Least One Treatment-Emergent Adverse Event (TEAE), Graded by Severity

Time: Up to Week 24

Measure: Number of Participants With Abnormal Laboratory Values

Time: Up to Week 24

Measure: Number of Participants With Abnormal Vital Signs Measurements

Time: Up to Week 24
2 A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of MEDI3506 in Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis (FRONTIER 4)

This 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.

NCT04631016
Conditions
  1. Chronic Obstructive Pulmonary Disease (COPD)
  2. Chronic Bronchitis
Interventions
  1. Biological: MEDI3506
  2. Other: Placebo
MeSH:Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Bronchitis Bronchitis, Chronic Acute Disease
HPO:Abnormal lung morphology Bronchitis Chronic bronchitis Chronic pulmonary obstruction Pulmonary obstruction

Primary Outcomes

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 12

Secondary Outcomes

Description: 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 36

Description: 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 36

Description: 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 36

Description: 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 28

Description: 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 12

Description: 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 12

Description: 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 12

Description: 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 12

Description: 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 12

Description: 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 12

Description: 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 12

Description: 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 12

Description: 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 12

Description: 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 12

HPO Nodes


Reports

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  

Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook