A Dose Escalation Study of Bradanicline in Refractory Chronic Cough

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Cough

In brief

This is a randomized, double-blind, placebo-controlled, crossover, dose escalation study of bradanicline in subjects with chronic cough

Key facts

Study ID

NCT03622216

Run by

Attenua, Inc.

People needed

46

Starts

2018-11-05

Expected to finish

2019-05-22

Last updated by the study team

2019-06-20

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chest radiograph or computed tomography (CT) scan of the thorax within the last 1 year not demonstrating any abnormality considered to be significantly contributing to the refractory chronic cough
• Diagnosis of refractory chronic cough or unexplained cough for at least one year
• Women of child-bearing potential who use 2 forms of acceptable birth control method
• Male subjects and their partners of child-bearing potential who use 2 methods of acceptable birth control
• Has provided written informed consent

You may not qualify if…

• Current smoker (cigarettes or e-cigarettes) or has given up smoking within the past 12 months
• Currently taking an ACE-inhibitor or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Baseline Visit
• Has an upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit
• Has a history of cystic fibrosis
• Has a history of malignancy within 5 years prior to the Baseline Visit
• Has active hepatitis infection
• Has a history of human immunodeficiency virus (HIV) infection
• Has a positive test for any drug of abuse
• Has a history of hypersensitivity to bradanicline or any of its components

Where it is running

• BioSolutions Clinical Research Center — La Mesa, California, United States
• Allergy & Asthma Associates of Southern California — Mission Viejo, California, United States
• Asthma and Allergy Associates — Colorado Springs, Colorado, United States
• Storms Clinical Research Institute — Colorado Springs, Colorado, United States
• Colorado Allergy and Asthma Center — Denver, Colorado, United States
• Center for Cough — Largo, Florida, United States
• Florida Pulmonary Research Institute — Winter Park, Florida, United States
• Clinical Research Institute — Plymouth, Minnesota, United States
• Mayo Clinic, Pulmonary Clinic Research Unit — Rochester, Minnesota, United States
• Atlantic Research Center, LLC — Ocean Township, New Jersey, United States
• Clinical Research of Gastonia — Gastonia, North Carolina, United States
• National Allergy and Asthma Research — North Charleston, South Carolina, United States
• AARA Research Center — Dallas, Texas, United States
• Pharmaceutical Research and Consulting, Inc. — Dallas, Texas, United States
• Diagnostics Research Group — San Antonio, Texas, United States
• Bellingham Asthma Allergy and Immunology Clinic — Bellingham, Washington, United States
• Allery Asthma & Sinus Center — Greenfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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