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CompletedNCT03622216Updated Jun 20, 2019

A Dose Escalation Study of Bradanicline in Refractory Chronic Cough

A Phase 2 interventional study of Bradanicline and Placebo in Chronic Cough, sponsored by Attenua, Inc.. Completed at 17 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-06-20.

Sponsored by Attenua, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2019, 7 years 5 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Chronic Cough
03

In context

Cough

346 studies on the registry are indexed under Cough; 71 are open to participants now.

This study's enrollment of 46 is below the median of 70 across 263 interventional studies indexed under Cough.

Browse Cough studies →

Lead sponsor

This is the only study on the registry with Attenua, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Bradanicline QD

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

    Drug: Bradanicline · Drug: Placebo

  • Placebo comparator
    Placebo

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

    Drug: Bradanicline · Drug: Placebo

Interventions

  • DrugBradanicline

    Three different doses over the course of the study

  • DrugPlacebo

    Matching placebo for Bradanicline

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Change from Baseline at Days 7, 14, 21, 43, 50, 57

Secondary outcomes

  1. 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

    Time frame: Change from Baseline at Days 7, 14, 21, 43, 50, 57

  2. 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)

    Time frame: up to 57 days

07

Study locations

17 sites
  • BioSolutions Clinical Research Center
    La Mesa, California 91942, United States
  • Allergy & Asthma Associates of Southern California
    Mission Viejo, California 92691, United States
  • Asthma and Allergy Associates
    Colorado Springs, Colorado 80907, United States
  • Storms Clinical Research Institute
    Colorado Springs, Colorado 80907, United States
  • Colorado Allergy and Asthma Center
    Denver, Colorado 80230, United States
  • Center for Cough
    Largo, Florida 33872, United States
  • Florida Pulmonary Research Institute
    Winter Park, Florida 32789, United States
  • Clinical Research Institute
    Plymouth, Minnesota 55441, United States
  • Mayo Clinic, Pulmonary Clinic Research Unit
    Rochester, Minnesota 55905, United States
  • Atlantic Research Center, LLC
    Ocean Township, New Jersey 07712, United States
  • Clinical Research of Gastonia
    Gastonia, North Carolina 20854, United States
  • National Allergy and Asthma Research
    North Charleston, South Carolina 29420, United States
  • AARA Research Center
    Dallas, Texas 75231, United States
  • Pharmaceutical Research and Consulting, Inc.
    Dallas, Texas 75231, United States
  • Diagnostics Research Group
    San Antonio, Texas 78229, United States
  • Bellingham Asthma Allergy and Immunology Clinic
    Bellingham, Washington 98225, United States
  • Allery Asthma & Sinus Center
    Greenfield, Wisconsin 53228, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03622216
Lead sponsor
Attenua, Inc.
Responsible party
Sponsor
First posted
Aug 9, 2018
Start date
Nov 5, 2018
Primary completion
May 7, 2019
Completion
May 22, 2019
Last update
Jun 20, 2019

Study contacts

Medical Director
study director · Attenua, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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