Actively Recruiting
Efficacy of Two Doses of Duloxetine & Amitriptyline in Interstitial Lung Disease-related Cough
Led by Mayo Clinic · Updated on 2026-01-21
25
Participants Needed
1
Research Sites
256 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 interstitial lung disease (ILD)-related cough.
CONDITIONS
Official Title
Efficacy of Two Doses of Duloxetine & Amitriptyline in Interstitial Lung Disease-related Cough
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a diagnosis of interstitial lung disease according to the American Thoracic Society Guidelines
- Have a chronic cough for at least 3 months prior to the screening visit
- Be on a stable dose of ILD-directed therapies for at least 3 months before enrollment and able to continue them
- Have a Cough Severity Visual Analog Scale score of 40 mm or higher at screening
- Women of child-bearing potential must use two forms of acceptable birth control and not donate eggs from screening through the 8-week study period
- Male participants and their partners of child-bearing potential must use two forms of acceptable birth control, including one barrier method, and not donate sperm from screening until 3 months after the last dose
- Provide written informed consent
- Be willing and able to follow all study procedures
You will not qualify if you...
- Current smoker or used cigarettes, e-cigarettes, or marijuana in the past 12 months
- Former smoker with a history of more than 20 pack-years
- Using an ACE inhibitor that causes cough or requires treatment with one during the study or within 12 weeks before screening
- Recent upper or lower respiratory infection or significant lung status change within 4 weeks before screening
- Used opioids or baclofen prescribed for chronic cough within 2 weeks before screening
- Have untreated or undertreated causes of chronic cough other than ILD, such as uncontrolled asthma or GERD
- Require prohibited medications during the study period
- Participated in another clinical trial disallowing co-enrollment within 4 weeks before screening
- Elevated liver enzymes or bilirubin over three times the normal limit at screening
- Severe kidney impairment or dialysis
- Advanced liver disease with cirrhosis or portal hypertension
- Previous allergy or intolerance to Duloxetine or Amitriptyline
- Currently pregnant or breastfeeding
- Any medical condition or disability interfering with safety or study assessments
- Planned major surgery or activities interfering with study participation
- Currently taking SSRIs, SNRIs, or MAO inhibitors that cannot be stopped at least 2 weeks before screening
- Use of prohibited cough therapies or investigational treatments during specified periods before and during the study
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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