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A Dose Escalation Study of Bradanicline in Refractory Chronic Cough

Primary Purpose

Chronic Cough

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bradanicline
Placebo
Sponsored by
Attenua, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Cough

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BioSolutions Clinical Research Center
  • Allergy & Asthma Associates of Southern California
  • Asthma and Allergy Associates
  • Storms Clinical Research Institute
  • Colorado Allergy and Asthma Center
  • Center for Cough
  • Florida Pulmonary Research Institute
  • Clinical Research Institute
  • Mayo Clinic, Pulmonary Clinic Research Unit
  • Atlantic Research Center, LLC
  • Clinical Research of Gastonia
  • National Allergy and Asthma Research
  • AARA Research Center
  • Pharmaceutical Research and Consulting, Inc.
  • Diagnostics Research Group
  • Bellingham Asthma Allergy and Immunology Clinic
  • Allery Asthma & Sinus Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bradanicline QD

Placebo

Arm Description

Randomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD

Randomized crossover design of matching placebo tablets to be administered orally QD

Outcomes

Primary Outcome Measures

Awake coughs per hour 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

24-hour coughs per hour 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
Percentage of participants who have at least one adverse event (AE) during the treatment periods, washout, and follow-up
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)

Full Information

First Posted
August 2, 2018
Last Updated
June 18, 2019
Sponsor
Attenua, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03622216
Brief Title
A Dose Escalation Study of Bradanicline in Refractory Chronic Cough
Official Title
A Dose Escalation Study to Assess the Efficacy and Safety of Bradanicline in Subjects With Refractory Chronic Cough
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
May 7, 2019 (Actual)
Study Completion Date
May 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Attenua, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bradanicline QD
Arm Type
Experimental
Arm Description
Randomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Randomized crossover design of matching placebo tablets to be administered orally QD
Intervention Type
Drug
Intervention Name(s)
Bradanicline
Intervention Description
Three different doses over the course of the study
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo for Bradanicline
Primary Outcome Measure Information:
Title
Awake coughs per hour at Days 7, 14, 21, 43, 50, 57
Description
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
Time Frame
Change from Baseline at Days 7, 14, 21, 43, 50, 57
Secondary Outcome Measure Information:
Title
24-hour coughs per hour at Days 7, 14, 21, 43, 50, 57
Description
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
Time Frame
Change from Baseline at Days 7, 14, 21, 43, 50, 57
Title
Percentage of participants who have at least one adverse event (AE) during the treatment periods, washout, and follow-up
Description
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)
Time Frame
up to 57 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Attenua, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
BioSolutions Clinical Research Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Allergy & Asthma Associates of Southern California
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Asthma and Allergy Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Storms Clinical Research Institute
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Colorado Allergy and Asthma Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Center for Cough
City
Largo
State/Province
Florida
ZIP/Postal Code
33872
Country
United States
Facility Name
Florida Pulmonary Research Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Clinical Research Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Mayo Clinic, Pulmonary Clinic Research Unit
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Atlantic Research Center, LLC
City
Ocean Township
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Clinical Research of Gastonia
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
20854
Country
United States
Facility Name
National Allergy and Asthma Research
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
AARA Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pharmaceutical Research and Consulting, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Bellingham Asthma Allergy and Immunology Clinic
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Allery Asthma & Sinus Center
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Dose Escalation Study of Bradanicline in Refractory Chronic Cough

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