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The purpose of this study is to determine the antitussive effect size and dose response of FP01 lozenges in subjects with chronic cough and to demonstrate the safety and tolerability of FP01 lozenges in subjects with chronic cough.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FP01 6mg or Placebo | Experimental | FP01 6mg Oral |
|
| FP01 12mg or Placebo | Experimental | FP01 12mg Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FP01 | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Cough Count/Frequency | Change in start-to-end difference in cough count, active vs. placebo treatment periods | Day 0-1, Day 14-15; Day 28-29, Day 42-43 |
| Measure | Description | Time Frame |
|---|---|---|
| LCQ | Start-to-end difference in Leicester Cough Questionnaire (LCQ) score, active vs. placebo treatment periods | Days 0, 14, 28, & 42 |
| VAS Score | Start-to-end difference in Visual analogue scale (VAS) score, active vs. placebo treatment periods |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Blake Paterson, MD | Avalo Therapeutics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy & Asthma Associates of Santa Clara Valley | San Jose | California | 95117 | United States | ||
| Sher Allergy Specialists |
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| Drug |
|
| Days 1, 14, 28, & 42 |
| Cough Severity Diary | Start-to-end difference in CSD score, active vs. placebo treatment periods | Days 0, 14, 28, & 42 |
| Largo |
| Florida |
| 33778 |
| United States |
| South Florida Clinical Research Trials, LLC | Miami | Florida | 33186 | United States |
| American Health Research | Charlotte | North Carolina | 28207 | United States |
| Wake Research, LLC | Raleigh | North Carolina | 27612 | United States |
| Oklahoma Institute of Allergy and Asthma | Oklahoma City | Oklahoma | 73131 | United States |
| Allergy, Asthma and Immunology Center, P.C./ Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | United States |
| Bellingham Asthma and Allergy Associates | Bellingham | Washington | 98225 | United States |