Study of Duloxetine and Amitriptyline for ILD-Related Cough
This study is looking at whether two medications, duloxetine and amitriptyline, can help reduce chronic (long-lasting) cough in people with interstitial lung disease (ILD). Researchers want to see if different doses of these drugs are effective. You could be eligible if you are between 18 and 75 years old, have an ILD diagnosis, and have had a chronic cough for at least three months. The main goal is to measure how much your cough frequency changes over 4 and 8 weeks. This study is currently recruiting 25 participants, but its status is unclear.
- Study design
- This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to a treatment group, and neither you nor your doctor will know which treatment you are receiving. It will involve 25 participants.
- What's involved
- You would take an oral medication for two 4-week periods. You will also have screening and baseline cough monitoring visits.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the 8-week blinded treatment period, you will be unblinded and can choose to continue amitriptyline or duloxetine, or explore other cough therapies. Participation in this unblinded follow-up is optional.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05120934
Efficacy of Two Doses of Duloxetine & Amitriptyline in Interstitial Lung Disease-related Cough
Recruiting
PHASE2Ages 18–75InterventionalTreatmentMayo ClinicInvestigator-initiated
~25 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:Amitriptyline 25 MGAmitriptyline 50 MGDuloxetine 30 MGDuloxetine 60 MGPlacebo 30 MGPlacebo 60 MG
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in awake objective cough frequency (at 4 & 8 weeks)
Measured over 4 weeks, 8 weeks
Conditions
Where it's being run
1 sites across 1 statesMinnesota1
Study leadership
- Vivek N Iyer, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Patients should be on a stable dose of ILD-directed therapies for 3 months prior to enrollment and will be allowed to continue their ILD-directed therapies. These include -but are not limited to- corticosteroids, immunosuppressing agents such as azathioprine and mycophenolate, as well as antifibrotic medications including nintedanib and pirfenidone. Additional corticosteroids and adjustment of ILD-directed therapy doses is permitted if deemed appropriate by the treating physician
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.
Male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control, 1 of which must be a barrier method, and make no donation of sperm from Screening until 3 months after the last dose of study drug at the end of 8 weeks.
Have provided written informed consent.
Are willing and able to comply with all aspects of the protocol.
Exclusion
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).
History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Screening/Baseline Visit (Day -14 to Day 0)
History of opioid use specifically prescribed for chronic cough within 2 weeks of the Screening/Baseline Visit (Day -14 to Day 0). Use of opioids for other indications (for example, to treat pain) is permitted.
History of baclofen use specifically prescribed for chronic cough within 2 weeks of the Screening/Baseline Visit (Day -14 to Day 0). Use of baclofen for other indications (for example, to treat spasticity) is permitted.
Presence of an untreated or undertreated cause (other than ILD) for the patient's chronic cough (as determined by the treating/referring physician per ACCP guidelines). e.g. uncontrolled asthma, GERD or post-nasal drainage that could potentially explain the patient's chronic cough.
Requiring concomitant therapy with prohibited medications (listed below).
Treatment with any pharmaceutical or biological investigational therapy (excluding coronavirus disease of 2019 (COVID) vaccination and COVID related monoclonal antibody therapy)
Participation in another clinical trial that does not allow co-enrollment within 4 weeks prior to the Screening/Baseline Visit (Day -14 to Day 0)
Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3x the upper limit of normal (ULN) during screening.
Serum creatinine \< 30 mL/min, hemodialysis or peritoneal dialysis
Advanced liver disease as defined by the presence of cirrhosis and/or signs of portal hypertension
History of previous hypersensitivity or intolerance to Duloxetine \& Amitriptyline (patients who have previously been on either amitriptyline or duloxetine for chronic cough or other reasons and have tolerated the medication will be offered participation regardless of previous response to therapy).
Currently pregnant or breastfeeding female subject.
Presence of any medical condition or disability that the investigators believe could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
Planned or anticipated major surgical procedure or other activity that would interfere with the subject's ability to comply with protocol-mandated assessments (e.g., extended travel) during the subject's participation in the study.
Currently taking either another SSRI, SNRI or MAO inhibitor which the patient cannot safely discontinue at least 2 weeks prior to the screening period.
Opioids (of any kind including tramadol \& codeine) specifically prescribed for treatment of cough
Dextromethorphan
Guaifenesin
Chlorpheniramine
Benzonatate
Trazodone
Pregabalin or gabapentin prescribed for chronic cough
1% tetracaine lollipops prescribed for chronic cough
4% nebulized lidocaine solution prescribed for chronic cough
Any SSRI (selective serotonin reuptake inhibitor) e.g. bupropion, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine.
Any SNRI (serotonin-norepinephrine reuptake inhibitor) e.g. venlafaxine, desvenlafaxine, milnacipran, levomilnacipran
Any Tricyclic antidepressant e.g. doxepin, clomipramine, nortriptyline, imipramine, protriptyline, amoxapine, trimipramine
Any MAO (Monoamine oxidase) inhibitor. e.g. phenelzine, selegiline, isocarboxacid or tranylcypromine
Patients who were previously prescribed either amitriptyline or duloxetine for chronic cough will be eligible for the study as long as they had discontinued the medication at least 12 weeks prior to the Screening/Baseline Visit (Day -14 to Day 0).
What this trial measures
- Change in awake objective cough frequency (at 4 & 8 weeks)4 weeks, 8 weeks
The primary objective is to evaluate awake cough frequency at 4 and 8 weeks using the Leicester Cough Monitor. The acoustic cough monitor recordings will be analyzed using the Leicester Cough Monitor program V2.3-MB. This will also be performed at months 4, 6, 9 \& 12 for subjects who choose to continue with the optional unblinded continuation of the study after the initial 8 weeks.