A Dose Escalation Study of Bradanicline in Refractory Chronic Cough
NCT ID: NCT03622216
Last Updated: 2019-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2018-11-05
2019-05-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Bradanicline QD
Randomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD
Bradanicline
Three different doses over the course of the study
Placebo
Matching placebo for Bradanicline
Placebo
Randomized crossover design of matching placebo tablets to be administered orally QD
Bradanicline
Three different doses over the course of the study
Placebo
Matching placebo for Bradanicline
Interventions
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Bradanicline
Three different doses over the course of the study
Placebo
Matching placebo for Bradanicline
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Attenua, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Attenua, Inc.
Locations
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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
Countries
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Other Identifiers
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ATA101-PN-001
Identifier Type: -
Identifier Source: org_study_id
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