慢性咳嗽患者におけるBAY1817080の3つの異なる用量の有効性と安全性をプラセボと比較して評価する臨床試験

基本情報

NCT ID

NCT04562155

ステータス

完了

試験のフェーズ

第2相

試験タイプ

介入

目標被験者数

310

治験依頼者名

Bayer

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (13)