An 8-Week Refractory Chronic Cough Study



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 80
Updated:4/19/2017
Start Date:December 17, 2015
End Date:May 18, 2016

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A Randomized, Parallel, Double-Blind Study to Assess the Efficacy and Tolerability of AF-219 in Subjects With Refractory Chronic Cough

This is an 8-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 respiratory tract infection or recent significant change in
pulmonary status within 4 weeks of the Baseline

- History of opioid use within 1 week of the Baseline Visit

- Body mass index (BMI) <18 kg/m2 or ≥ 37 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

- Significantly abnormal laboratory tests at Screening

- Clinically significant abnormal electrocardiogram (ECG)

- 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
10
sites
San Jose, California
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Bellevue, Washington
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Bellevue, WA
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Charlotte, North Carolina
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Charlotte, NC
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Colorado Springs, Colorado
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Colorado Springs, CO
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Dallas, Texas 75231
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Dallas, TX
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Greenfield, Wisconsin
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Greenfield, WI
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Largo, FL
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Mission Viejo, California
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Mission Viejo, CA
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San Antonio, Texas 78209
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San Antonio, TX
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Tulsa, Oklahoma
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Tulsa, OK
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