A Study to Assess the Effectiveness and Safety of AF-219 for Subjects with a Treatment Resistant Chronic Cough

Overview

About this study

The purpose of this study is to assess the effectiveness and safety of AF-219 given to subjects with a treatment resistant chronic 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

  • Women and Men between 18 and 80 years of age inclusive
  • Have refractory chronic cough
  • Women of child-bearing potential must use 2 forms of acceptable birth control 
  • Have provided written informed consent
  • Are willing and able to comply with all aspects of the protocol

Exclusion Criteria

  • Current smoker
  • FEV1/FVC < 60%
  • History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the baseline visit
  • History of opioid use within 1 week of the baseline visit
  • Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2
  • History of concurrent malignancy or recurrence of malignancy within 2 years prior to screening (not including subjects with <3 excised basal cell carcinomas)
  • Screening systolic blood pressure >160 mm Hg or a diastolic blood pressure >90 mm Hg
  • Clinically significant abnormal electrocardiogram (ECG) at screening
  • Significantly abnormal laboratory tests at screening
  • Pregnant or breastfeeding
  • Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the Investigator or sponsor, would make the subject inappropriate for entry into this trial

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

More information

Publications

Publications are currently not available
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CLS-20266929

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