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A Dose Escalation Study of Bradanicline in Refractory Chronic Cough

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03622216
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : June 20, 2019
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.

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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : May 7, 2019
Actual Study Completion Date : May 22, 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)



Information from the National Library of Medicine

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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


Locations
Show Show 17 study locations
Sponsors and Collaborators
Attenua, Inc.
Investigators
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Study Director: Medical Director Attenua, Inc.

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Responsible Party: Attenua, Inc.
ClinicalTrials.gov Identifier: NCT03622216    
Other Study ID Numbers: ATA101-PN-001
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms