A 12-Week Study in Subjects With Refractory Chronic Cough



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 80
Updated:12/7/2017
Start Date:December 15, 2015
End Date:November 4, 2016

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A 12-Week Study to Assess the Efficacy and Safety of AF 219 in Subjects With Refractory Chronic Cough

This is a 12-week, randomized, parallel, double-blind, placebo-controlled study of gefapixant
(AF-219) in subjects with refractory chronic cough.


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 (SBP) >160 mm Hg or a diastolic blood pressure (DBP)
>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
We found this trial at
17
sites
Rock Hill, South Carolina
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Rock Hill, SC
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Baltimore, Maryland
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Baltimore, MD
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Bellevue, Nebraska
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Bellevue, NE
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Centennial, Colorado
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Centennial, CO
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Charlotte, North Carolina
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Charlotte, NC
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Chesterfield, Missouri
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Chesterfield, MO
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Dallas, Texas 75231
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Dallas, TX
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Denver, Colorado
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Denver, CO
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Largo, FL
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Miami, FL
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Minneapolis, Minnesota
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Minneapolis, MN
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Mission Viejo, California
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Mission Viejo, CA
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New Braunfels, Texas
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New Braunfels, TX
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Rochester, Minnesota
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Rochester, MN
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Rochester, New York
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Rochester, NY
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Tulsa, Oklahoma
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Tulsa, OK
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Winter Park, Florida
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Winter Park, FL
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