A Dose Escalation Study of Bradanicline in Refractory Chronic Cough
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| ClinicalTrials.gov Identifier: NCT03622216 |
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Recruitment Status :
Completed
First Posted : August 9, 2018
Last Update Posted : June 20, 2019
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Sponsor:
Attenua, Inc.
Information provided by (Responsible Party):
Attenua, Inc.
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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 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Bradanicline QD
Randomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD
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Drug: Bradanicline
Three different doses over the course of the study Drug: Placebo Matching placebo for Bradanicline |
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Placebo Comparator: Placebo
Randomized crossover design of matching placebo tablets to be administered orally QD
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Drug: Bradanicline
Three different doses over the course of the study Drug: Placebo Matching placebo for Bradanicline |
Primary Outcome Measures :
- 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 :
- 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
- 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
Locations
Show 17 study locations
Sponsors and Collaborators
Attenua, Inc.
Investigators
| Study Director: | Medical Director | Attenua, Inc. |
| 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 |
| 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 |