CovidResearchTrials by Shray Alag


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Report for D001991: Bronchitis NIH

(Synonyms: Bronchitis)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)


Name (Synonyms) Correlation
drug1362 ION-827359 Wiki 1.00
drug35 2D Telemedicine Wiki 0.71
drug44 3D Telemedicine Wiki 0.58
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (5)


Name (Synonyms) Correlation
D029481 Bronchitis, Chronic NIH 1.00
D000208 Acute Disease NIH 0.71
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.35
D008173 Lung Diseases, Obstructive NIH 0.33
D008171 Lung Diseases, NIH 0.24

Correlated HPO Terms (5)


Name (Synonyms) Correlation
HP:0012387 Bronchitis HPO 1.00
HP:0004469 Chronic bronchitis HPO 1.00
HP:0006510 Chronic pulmonary obstruction HPO 0.35
HP:0006536 Pulmonary obstruction HPO 0.33
HP:0002088 Abnormal lung morphology HPO 0.24

There is one clinical trial.

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 Chronic Bronchitis Chronic Obstructive Pulmonary Disease Drug: ION-827359 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


HPO Nodes