Actively Recruiting
Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough
Led by Mayo Clinic · Updated on 2026-01-21
50
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official 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 CT scan of the chest in the last year showing no significant abnormalities related to chronic cough
- Diagnosis of refractory or unexplained chronic cough lasting at least 1 year according to guidelines
- Cough severity score of 40mm or higher on the Cough Severity Visual Analog Scale at screening
- Women of child-bearing potential must agree to use two acceptable forms of birth control and not donate eggs during the study period
- Male subjects and their partners must use two forms of acceptable birth control, including one barrier method, and not donate sperm during the study period
- Able and willing to comply with all study procedures
- Provided written informed consent
You will not qualify if you...
- Current smoker or smoked any cigarettes, e-cigarettes, or marijuana within the past 12 months
- Former smoker with more than 20 pack-year smoking history
- Taking or requiring treatment with ACE-inhibitors 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
- Use of opioids or baclofen specifically for chronic cough within 2 weeks before screening
- Diagnosis of COPD, bronchiectasis, interstitial lung disease, or cystic fibrosis
- Untreated or undertreated causes of chronic cough such as uncontrolled asthma or GERD
- Taking prohibited medications during screening or treatment periods including certain cough medicines, antidepressants, and investigational therapies
- Abnormal liver or kidney function tests beyond specified limits
- Advanced liver disease
- Known allergy or intolerance to Duloxetine or Amitriptyline
- Currently pregnant or breastfeeding
- Any medical condition that could interfere with safety or study assessments
- Planned major surgery or activities interfering with study participation
- Inability to safely discontinue certain antidepressants at least 2 weeks before screening
- Participation in another clinical trial disallowing co-enrollment within 4 weeks before screening
AI-Screening
AI-Powered Screening
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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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