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

• Status: Completed
• Trial end date: 2019-02-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nerre Therapeutics Ltd.
• Treatments: Maleic acid

Criteria

Key Inclusion Criteria:

• Male and female subjects ≥18 years of age.

• Diagnosis of CRC or unexplained cough for at least 1 year (see ACCP/BTS guidelines attached).

• A awake average cough frequency of ≥10 coughs/ hour, as assessed using an ACM during the screening period.

Key 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.