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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMayo Clinic

About this trial

This research study is evaluating the effectiveness of escalating doses of Amitriptyline and Duloxetine in reducing cough frequency in patients with refractory chronic cough (RCC)

Eligibility criteria

Qualifiers

Chest radiograph or computed tomography (CT) of the thorax within the last 1 year not demonstrating any abnormality considered to be significantly contributing to the refractory chronic cough in the opinion of the Principal Investigator

Have a diagnosis of refractory chronic cough or unexplained cough for at least one year according to the American College of Chest Physicians guidelines

Have a score of ≥ 40mm on the Cough Severity VAS at Screening.

Women of child-bearing potential must agree to use 2 forms of acceptable birth control and make no donation of eggs from Screening through the end of the 8-week study period. Acceptable birth control methods include established use of oral, injected, or implanted hormonal methods of contraception; intrauterine device (IUD) or intrauterine system (IUS); tubal ligation; or male sterilization. Double-barrier method (diaphragm for female subject and condom for male partner with spermicidal) satisfies the requirement for 2 forms of acceptable birth control. When concordant with the preferred lifestyle of the subject, true and complete abstinence (not periodic abstinence) is acceptable.

Disqualifiers

Current smoker (cigarettes, e-cigarettes or marijuana) or former smokers who have smoked within the past 12 months.

Former smokers with > 20 pack-year history of smoking

Ongoing treatment with an ACE-inhibitor that is considered as the potential cause of a subject's cough or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Screening/Baseline Visit (Day -14 to Day 0).

FEV1/FVC < 60%.

Trial design

Treatments tested in this trial

  • Duloxetine 30 MG
  • Duloxetine 60 MG
  • Amitriptyline 25 MG
  • Amitriptyline 50 MG
  • Placebo 30 MG
  • Placebo 60 MG

Treatment groups

50 Participants
are divided into 5 treatment groups

Sponsors and collaborators