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A Dose Escalation Study of Bradanicline in Refractory Chronic Cough

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ClinicalTrials.gov Identifier: NCT03622216
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Attenua, Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Cough Drug: Bradanicline Drug: Placebo Phase 2

Detailed Description:
This study will have two 21-day treatment periods separated by a 14-day washout period. There will be a 14-day follow-up period.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Dose Escalation Study to Assess the Efficacy and Safety of Bradanicline in Subjects With Refractory Chronic Cough
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: Bradanicline QD
Randomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD
Drug: Bradanicline
Three different doses over the course of the study

Drug: Placebo
Matching placebo for Bradanicline

Placebo Comparator: Placebo
Randomized crossover design of matching placebo tablets to be administered orally QD
Drug: Bradanicline
Three different doses over the course of the study

Drug: Placebo
Matching placebo for Bradanicline




Primary Outcome Measures :
  1. Awake coughs per hour at Days 7, 14, 21, 43, 50, 57 [ Time Frame: Change from Baseline at Days 7, 14, 21, 43, 50, 57 ]
    Assessment of awake coughs per hour (average hourly cough frequency while the participant is awake based on sound recordings), to be evaluated using a digital recording device


Secondary Outcome Measures :
  1. 24-hour coughs per hour at Days 7, 14, 21, 43, 50, 57 [ Time Frame: Change from Baseline at Days 7, 14, 21, 43, 50, 57 ]
    Assessment of 24-hour coughs per hour (average hourly cough frequency based on 24-hour sound recordings), to be evaluated using a digital recording device

  2. Percentage of participants who have at least one adverse event (AE) during the treatment periods, washout, and follow-up [ Time Frame: up to 57 days ]
    Assessment of participants who have at least one AE during treatment period 1 (21 days), during washout (14 days), during treatment period 2 (21 days), and follow-up (14 days)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622216


Contacts
Contact: Medical Director 650-490-4004 info@attenua.com

Locations
United States, California
Allergy & Asthma Associates of Southern California Recruiting
Mission Viejo, California, United States, 92691
Contact: Study coordinator    949-347-8700      
United States, Colorado
Asthma and Allergy Associates Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Study coordinator    719-473-0872      
Storms Clinical Research Institute Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Study coordinator    719-955-6000      
Colorado Allergy and Asthma Center Recruiting
Denver, Colorado, United States, 80230
Contact: Study coordinator    720-858-7510      
United States, Florida
Florida Pulmonary Research Institute Recruiting
Winter Park, Florida, United States, 32789
Contact: Study coordinator    407-740-8078      
United States, Minnesota
Clinical Research Institute Recruiting
Plymouth, Minnesota, United States, 55441
Contact: Study coordinator    763-744-1140      
Mayo Clinic, Pulmonary Clinic Research Unit Recruiting
Rochester, Minnesota, United States, 55905
Contact: Study Coordinator    507-284-2158      
United States, New Jersey
Atlantic Research Center, LLC Recruiting
Ocean Township, New Jersey, United States, 07712
Contact: Study coordinator    732-695-2555 ext 111      
United States, South Carolina
National Allergy and Asthma Research Recruiting
North Charleston, South Carolina, United States, 29420
Contact: Study coordinator    843-820-1036      
United States, Texas
AARA Research Center Recruiting
Dallas, Texas, United States, 75231
Contact: Study coordinator    214-365-0365      
Pharmaceutical Research and Consulting, Inc. Recruiting
Dallas, Texas, United States, 75231
Contact: Study coordinator    214-361-5555      
Diagnostics Research Group Recruiting
San Antonio, Texas, United States, 78229
Contact: Study coordinator    210-692-7157      
United States, Washington
Bellingham Asthma Allergy and Immunology Clinic Recruiting
Bellingham, Washington, United States, 98225
Contact: Study coordinator    360-733-5733      
United States, Wisconsin
Allery Asthma & Sinus Center Recruiting
Greenfield, Wisconsin, United States, 53228
Contact: Study coordinator    414-529-8519      
Sponsors and Collaborators
Attenua, Inc.
Investigators
Study Director: Medical Director Attenua, Inc.

Responsible Party: Attenua, Inc.
ClinicalTrials.gov Identifier: NCT03622216     History of Changes
Other Study ID Numbers: ATA101-PN-001
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms