study of the efficacy, safety, and tolerability of serlopitant for the treatment of refractory chronic cough

Conditions: Refractory Chronic Cough

Summary: study of the efficacy, safety, and tolerability of serlopitant for the treatment of refractory chronic cough


Eligibility criteria:
inclusion criteria: * female and males between 18 and 80 years of age * have a diagnosis of treatment refractory chronic cough or unexplained cough for at least one year * chest radiograph or computed tomography (ct) thorax within the last 5 years not demonstrating any abnormality considered to be significantly contributing to the chronic cough * at screening have a score of ≥ 40mm on the cough severity vas * at baseline (day 0) have a score of ≥ 40mm on the cough severity vas * all female subjects who are of childbearing potential must practice highly effective contraception (i.e., pregnancy prevention method with a failure rate of \< 1% per year) from the time of the initial screening visit until 4 weeks after last dose of study drug. please refer to the protocol for acceptable methods of contraception exclusion criteria: * prior treatment with serlopitant or other nk1-r antagonist * presence of any medical condition or disability that could interfere with study * history of hypersensitivity to serlopitant or any of its components * currently pregnant or male partner of pregnant female * females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding * current smoker or individuals who have given up smoking within the past 12 months * fev1/fvc \< 60% * body mass index (bmi) \<18 kg/m2 or ≥ 40 kg/m2 at screening * history of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the baseline visit (day 0) * history of cystic fibrosis * history of opioid use within 1 week of the baseline visit (day 0) * requiring concomitant therapy with prohibited medications * treatment with biologic therapies within 8 weeks or 5 half-lives prior to the baseline visit (day 0), whichever is longer * treatment with strong cyp3a4 inhibitors within 4 weeks prior to the baseline visit (day 0) * treatment with any investigational therapy within 4 weeks (investigational biologic therapies within 8 weeks) prior to the baseline visit (day 0) * serum creatinine, total bilirubin, alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 2x the upper limit of normal (uln) during screening * positive test for any drug of abuse * history of malignancy within 5 years prior to the baseline visit (day 0), with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin * any known psychiatric diagnosis meeting dsm-5 criteria which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to randomization. examples of such dsm-5 diagnoses include but are not limited to major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder. * known active hepatitis infection * known history of human immunodeficiency virus (hiv) infection