Clinical trial NCT03622216: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Cough
Lead sponsor: Attenua, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Awake coughs per hour at Days 7, 14, 21, 43, 50, 57
timeFrame: Change from Baseline at Days 7, 14, 21, 43, 50, 57
Secondary outcomes:
measure: 24-hour coughs per hour at Days 7, 14, 21, 43, 50, 57
timeFrame: Change from Baseline at Days 7, 14, 21, 43, 50, 57
measure: Percentage of participants who have at least one adverse event (AE) during the treatment periods, washout, and follow-up
timeFrame: up to 57 days
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: BioSolutions Clinical Research Center
state: California
city: Mission Viejo
country: United States
facility: Allergy & Asthma Associates of Southern California
state: California
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates
state: Colorado
city: Colorado Springs
country: United States
facility: Storms Clinical Research Institute
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy and Asthma Center
state: Colorado
city: Largo
country: United States
facility: Center for Cough
state: Florida
city: Winter Park
country: United States
facility: Florida Pulmonary Research Institute
state: Florida
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic, Pulmonary Clinic Research Unit
state: Minnesota
city: Ocean Township
country: United States
facility: Atlantic Research Center, LLC
state: New Jersey
city: Gastonia
country: United States
facility: Clinical Research of Gastonia
state: North Carolina
city: North Charleston
country: United States
facility: National Allergy and Asthma Research
state: South Carolina
city: Dallas
country: United States
facility: AARA Research Center
state: Texas
city: Dallas
country: United States
facility: Pharmaceutical Research and Consulting, Inc.
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Bellingham
country: United States
facility: Bellingham Asthma Allergy and Immunology Clinic
state: Washington
city: Greenfield
country: United States
facility: Allery Asthma & Sinus Center
state: Wisconsin
Study officials:
affiliation: Attenua, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: