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D003371: Cough

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 (3)


Name (Synonyms) Correlation
drug3736 XatJove Anoia Aplication Wiki 1.00
drug381 BAY1817080 Wiki 0.71
drug2505 Placebo Wiki 0.05

Correlated MeSH Terms (0)


Name (Synonyms) Correlation

Correlated HPO Terms (0)


Name (Synonyms) Correlation

Clinical Trials

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There is one clinical trial.


1 Randomized, Double-blind, Parallel Group, Phase 2b Dose-finding, Efficacy and Safety Study of 12-week Twice Daily Oral Administration of BAY 1817080 Compared to Placebo in the Treatment of Refractory and/or Unexplained Chronic Cough (RUCC)

Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC). Study drug BAY1817080 is a new drug under development for the treatment of long-standing cough. It blocks proteins that are expressed by the airway sensory nerves which are oversensitive in patients with long-standing cough. This prevents the urge to cough. Researchers also want to learn the safety of the study drug and how well it works in reducing the cough frequency, severity and urge-to-cough. Participants in this study will receive either the study drug or placebo (a placebo looks like the test drug but does not have any medicine in it) tablets twice daily for 12 weeks. Observation for each participant will last about 18 weeks in total. Participants will be asked to wear a digital device to record the cough and to complete questionnaires every day to document the symptoms. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

NCT04562155
Conditions
  1. Refractory and/or Unexplained Chronic Cough
Interventions
  1. Drug: BAY1817080
  2. Drug: Placebo
MeSH:Cough
HPO:Cough

Primary Outcomes

Measure: Change from baseline in 24-hour cough count (measured by cough recording digital wearable monitoring device) after 12 weeks of intervention

Time: From baseline up to 12 weeks

Secondary Outcomes

Measure: Percentage of participants with a ≥30% reduction from baseline in 24-hour cough count after 12 weeks of intervention (measured by cough recording digital wearable monitoring device)

Time: From baseline up to 12 weeks

Measure: Change from baseline in 24-hour cough count after 2, 4, and 8 weeks of intervention (measured by cough recording digital wearable monitoring device)

Time: From baseline up to 2 weeks, 4 weeks and 8 weeks

Measure: Change from baseline in awake cough frequency per hour after 2, 4, 8 and 12 weeks of intervention (measured by cough recording digital wearable monitoring device)

Time: From baseline up to 2 weeks, 4 weeks, 8 weeks and 12 weeks

Measure: Change from baseline in cough related quality of life (measured by Leicester Cough Questionnaire [LCQ]) after 12 weeks of intervention

Time: From baseline up to 12 weeks

Measure: Change from baseline in cough severity after 12 weeks of intervention (measured by Cough Severity Visual Analogue Scale [VAS])

Time: From baseline up to 12 weeks

Measure: Percentage of participants with a ≥30 scale units reduction from baseline after 12 weeks of intervention (measured by cough Severity VAS)

Time: From baseline up to 12 weeks

Measure: Percentage of participants with a ≥1.3-point increase from baseline after 12 weeks of intervention (measured with LCQ Total Score)

Time: From baseline up to 12 weeks

Measure: Frequency and associated severity of treatment-emergent adverse events (TEAEs)

Time: From the start of study intervention administration until 14 days after the last study medication intake

HPO Nodes


Reports

Data processed on September 26, 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.

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