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A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating the Efficacy of Two Doses of Duloxetine & Amitriptyline in Subjects With Refractory Chronic Cough
Led by Mayo Clinic · Updated on 2026-01-21
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chest X-ray or chest CT scan within the last year showing no significant abnormality causing the cough
- Diagnosis of refractory chronic cough or unexplained cough for at least one year
- Cough Severity Visual Analogue Scale score of 40 mm or higher at screening
- Women of child-bearing potential must use two acceptable birth control methods and avoid egg donation during the study
- Male participants and their partners must use two birth control methods, including a barrier method, and avoid sperm donation during the study
- Provided written informed consent
- Willing and able to follow the study protocol
You will not qualify if you...
- Current smoker or smoked any cigarettes, e-cigarettes, or marijuana within the past 12 months
- Former smokers with over 20 pack-year history
- Using ACE-inhibitors currently or within 12 weeks before screening
- Lung function with FEV1/FVC less than 60%
- Recent respiratory infection or significant lung status change within 4 weeks before screening
- Opioid or baclofen use specifically for chronic cough within 2 weeks before screening
- Diagnosis of COPD, bronchiectasis, interstitial lung disease, or cystic fibrosis
- Untreated causes for chronic cough like uncontrolled asthma or reflux disease
- Using prohibited medications such as certain cough medicines, antidepressants, or investigational therapies
- Liver or kidney impairment beyond specified limits
- History of allergy or intolerance to Duloxetine or Amitriptyline
- Currently pregnant or breastfeeding
- Medical conditions or disabilities interfering with study safety or assessment
- Planned major surgery or activities that prevent compliance with study visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - up to 2 weeks
Participants are screened for eligibility to participate in the trial.
screening and baseline cough monitoring
Duration - 8 weeks
Participants receive two successive 4-week blinded treatment periods with Duloxetine, Amitriptyline, or Placebo depending on their assigned arm.
Visits during two 4-week treatment periods (visit frequency per protocol)
Duration - up to 52 weeks
Participants enter an optional unblinded follow-up phase where they receive routine clinical care for their chronic cough, with options to continue initial therapies or try alternative treatments.
Visit schedule as per routine clinical care
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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