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Tricyclic Antidepressant
Duloxetine + Amitriptyline for Interstitial Lung Disease-related Cough (MACS-2 Trial)
Phase 2
Recruiting
Led By Vivek N Iyer, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks, 8 weeks
Awards & highlights
MACS-2 Trial Summary
This trial is testing if two drugs commonly used to treat depression can also help reduce coughing in people with interstitial lung disease.
Who is the study for?
This trial is for adults with interstitial lung disease who've had a chronic cough for at least 3 months, are on stable ILD treatments, and can follow the study plan. Women must use two birth control methods or practice complete abstinence; men also need to use two forms of contraception. Smokers, those with certain liver issues, pregnant/breastfeeding women, and people on conflicting medications or other trials cannot participate.Check my eligibility
What is being tested?
The study tests whether increasing doses of Amitriptyline (25mg or 50mg) and Duloxetine (30mg or 60mg) can reduce coughing in ILD patients compared to placebo. Participants will be randomly assigned to receive one of these drugs or a matching placebo over an eight-week period while continuing their usual ILD therapies.See study design
What are the potential side effects?
Potential side effects include dry mouth, drowsiness, constipation, blurred vision from Amitriptyline; nausea, headache, dry mouth, sleepiness from Duloxetine. Side effects vary by individual and dosage.
MACS-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks, 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks, 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in awake objective cough frequency (at 4 & 8 weeks)
Secondary outcome measures
Change from Baseline in Leicester Cough Questionnaire (LCQ-acute) individual domain and total scores
Change in 24-Hour cough frequency
Change in Cough Severity Diary score
+1 moreMACS-2 Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: Duloxetine dose escalationExperimental Treatment2 Interventions
Subjects will receive 30mg of Duloxetine for blinded period 1 (first 4 week treatment period) and 60mg of Duloxetine for blinded period 2 (additional 4 weeks treatment period). After this, subjects will be unblinded and receive routine clinical care for follow up phase (up to 52 weeks).
Group II: Duloxetine and PlaceboExperimental Treatment2 Interventions
Subjects will receive 30mg of Duloxetine for blinded period 1 (first 4 week treatment period) and 30mg of Duloxetine plus 30mg Placebo for blinded period 2 (additional 4 weeks treatment period). After this, subjects will be unblinded and receive routine clinical care for follow up phase (up to 52 weeks).
Group III: Amitriptyline dose escalationExperimental Treatment2 Interventions
Subjects will receive 25mg of Amitriptyline for blinded period 1 (first 4 week treatment period) and 50mg of Amitriptyline for blinded period 2 (additional 4 weeks treatment period). After this, subjects will be unblinded and receive routine clinical care for follow up phase (up to 52 weeks).
Group IV: Amitriptyline and PlaceboExperimental Treatment2 Interventions
Subjects will receive 25mg of Amitriptyline for blinded period 1 (first 4 week treatment period) and 25mg of Amitriptyline plus 30mg Placebo for blinded period 2 (additional 4 weeks treatment period). After this, subjects will be unblinded and receive routine clinical care for follow up phase (up to 52 weeks).
Group V: PlaceboPlacebo Group2 Interventions
Subjects will receive 30mg of Placebo for blinded period 1 (first 4 week treatment period) and 60mg of Placebo for blinded period 2 (additional 4 weeks treatment period). After this, subjects will be unblinded and receive routine clinical care for follow up phase (up to 52 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duloxetine 30 MG
2021
Completed Phase 2
~330
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,115 Total Patients Enrolled
Vivek N Iyer, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You used to smoke a lot, at least 20 packs of cigarettes per year.You currently smoke cigarettes, e-cigarettes, or marijuana, or you have quit smoking within the past year.Your cough is very severe, with a score of 40mm or higher on a scale used to measure cough severity.You have not used opioids specifically for chronic cough within the past two weeks. However, if you have used opioids for other reasons, like pain, that is allowed.You are currently taking a medication called an ACE-inhibitor that may cause coughing, or you have taken this medication within the past 12 weeks before the study.Your chronic cough may be caused by other untreated or undertreated conditions like asthma, acid reflux, or post-nasal drip.You have had a bad reaction or intolerance to duloxetine or amitriptyline in the past. However, if you have taken either of these medications before and tolerated them well, you can still participate in the study, even if they didn't work for your previous condition.You have been coughing for at least 3 months before the screening visit.You have taken baclofen specifically for chronic cough within the past two weeks before the screening visit. It's okay if you have taken baclofen for other reasons, like treating muscle stiffness.You have had a recent respiratory infection or significant changes in your lung health within the past 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Duloxetine and Placebo
- Group 2: Amitriptyline dose escalation
- Group 3: Amitriptyline and Placebo
- Group 4: Duloxetine dose escalation
- Group 5: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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