Clinical Trial Details

Overview

Research Study Summary

A Double-Blind, Randomized, Placebo Controlled Study of the Efficacy and Safety of Three Doses of Orvepitant in Subjects With Chronic Refractory Cough

Purpose

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.

To Learn more

CW ID: 226017
Date Last Changed: August 16, 2017

Clinical Trial Snapshot

Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Nerre Therapeutics Ltd.
Facility Type

Eligibility

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.
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.
  • More Info

    VOLCANO-2

    Contact

    Renee Smith
    University of South Florida- Asthma, Allergy, and Immunology Clinical Research Unit
    13801 Bruce B Downs Blvd. Suite 505
    Tampa, FL 33613
    Phone: (813) 631-4024 ext. 207

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