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This is a randomized, double-blind, placebo-controlled, crossover, dose escalation study of bradanicline in subjects with chronic cough
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bradanicline QD | Experimental | Randomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD |
|
| Placebo | Placebo Comparator | Randomized crossover design of matching placebo tablets to be administered orally QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bradanicline | Drug | Three different doses over the course of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from Baseline at Days 7, 14, 21, 43, 50, 57 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from Baseline at Days 7, 14, 21, 43, 50, 57 |
| Percentage of participants who have at least one adverse event (AE) during the treatment periods, washout, and follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Attenua, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioSolutions Clinical Research Center | La Mesa | California | 91942 | United States | ||
| Allergy & Asthma Associates of Southern California |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 17, 2019 | |
| Reset | Jan 10, 2020 |
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| Placebo | Drug | Matching placebo for Bradanicline |
|
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) |
| up to 57 days |
| 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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 17, 2019 | Jan 10, 2020 |
| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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