A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough

Overview

About this study

The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of chronic refractory cough.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male and female subjects ≥18 years of age.
  • Diagnosis of CRC or unexplained cough for at least 1 year.
  • A awake average cough frequency of ≥10 coughs/ hour, as assessed using an ACM during the screening period.

Exclusion Criteria:

  • Subjects with respiratory tract infection (<4 weeks prior to study start)
  • Current smokers or ex-smokers with <6 months' abstinence or cumulative history of >10 pack years
  • Treatment with Angiotensin Converting Enzyme (ACE) inhibitors within 3 months of screening
  • FEV1 <80% predicted, measured at screening using spirometry
  • History of cystic fibrosis, idiopathic pulmonary fibrosis, clinically significant bronchiectasis, moderate to severe asthma, chronic obstructive pulmonary disease (COPD)
  • Any clinically significant abnormal laboratory test result(s)
  • Inability to comply with the use of prohibited and allowed medications as described in the protocol.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Vivek Iyer, M.D.

Closed for enrollment

Jacksonville, Fla.

Mayo Clinic principal investigator

Vivek Iyer, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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