Study of Duloxetine and Amitriptyline at Two Dose Levels to Treat Refractory Chronic Cough in Adults

What this Trial Is About

Researchers are evaluating how well two doses of the drugs Duloxetine and Amitriptyline work in reducing cough frequency in adults with refractory chronic cough, a cough that does not respond to usual treatments. This study is a randomized, double-blind, placebo-controlled trial designed to compare these medications in a dose-escalation format, allowing researchers to assess their potential effects on this challenging condition. Participants are randomly assigned to one of five groups, each receiving different doses or placebos in two consecutive 4-week periods. The groups include low and higher doses of Duloxetine and Amitriptyline, as well as placebo groups. After these blinded treatment phases, participants enter an optional follow-up period of up to 52 weeks, where they receive routine clinical care and may continue treatment or try other therapies for chronic cough. During the study, participants undergo screening and baseline cough monitoring before starting treatment. Researchers measure changes in cough frequency using objective cough counts and questionnaires assessing cough severity and impact on quality of life at 4 and 8 weeks. The study includes close monitoring for safety and treatment adherence, with follow-up care provided after the blinded treatment phases.

Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough