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Tricyclic Antidepressant
Duloxetine and Amitriptyline for Refractory Chronic Cough (MACS-1 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-1 Trial Summary
This trial is testing if two drugs commonly used for other conditions can help reduce cough frequency in people who have not responded to other treatments.
Who is the study for?
This trial is for adults with a persistent cough lasting over a year, not explained by other lung conditions. Participants must use two forms of birth control and cannot be pregnant or breastfeeding. They should not have severe liver issues, recent infections, or be on certain medications like SSRIs, SNRIs, MAO inhibitors, or specific cough treatments.Check my eligibility
What is being tested?
The study tests whether different doses of Duloxetine (30 MG & 60 MG) and Amitriptyline (25 MG & 50 MG), compared to placebos (30 MG & 60 MG), can reduce the frequency of chronic cough in patients who haven't responded to usual treatments.See study design
What are the potential side effects?
Duloxetine and Amitriptyline may cause dry mouth, drowsiness, constipation, blurred vision and weight gain. Some people might experience mood changes or difficulty urinating. Side effects vary from person to person.
MACS-1 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-1 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 week 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 week 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
FDA approved
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,234 Previous Clinical Trials
3,771,799 Total Patients Enrolled
2 Trials studying Chronic Cough
49 Patients Enrolled for Chronic Cough
Vivek N Iyer, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have stopped taking baclofen for chronic cough within the past 2 weeks. It's okay if you take baclofen for other reasons, like treating muscle spasms.I'm sorry, but the provided criterion does not appear to be specific enough. "Guaifenesin" is a medication used to relieve cough and congestion. It is not clear how this relates to screening criteria for a clinical trial. Could you please provide more context or specific information?You cannot be currently participating in any experimental treatments, except for COVID vaccinations or COVID-related monoclonal antibody therapy.You have had a recent infection or significant changes in your lungs within the past 4 weeks.You have taken medicine containing opioids for a cough that lasted longer than 2 weeks within the 2 weeks before the screening visit. Using opioids for other reasons, like treating pain, is allowed.You have a sensitivity or allergy to dextromethorphan.You are taking or have a known allergy to the medication benzonatate.You are taking pregabalin or gabapentin for a chronic cough.You are currently using 1% tetracaine lollipops for chronic cough.You are taking a 4% nebulized lidocaine solution for chronic cough.You have been diagnosed with a persistent cough that has lasted for at least a year and doesn't have a clear cause according to the guidelines from the American College of Chest Physicians.You have had an allergic reaction or couldn't tolerate duloxetine and amitriptyline in the past. However, if you have taken these medications before for chronic cough or other reasons and were able to tolerate them, you can still participate in the study regardless of how well they worked for you.You are currently taking certain medications called SNRIs, like venlafaxine, desvenlafaxine, milnacipran, or levomilnacipran.You are currently taking opioids, including medications like tramadol and codeine, specifically for treating a cough.You are currently taking medication called ACE-inhibitors.You have an underlying condition, like uncontrolled asthma, acid reflux, or nasal drainage, that could be causing your chronic cough and it needs to be treated or managed before participating in the study.You are currently taking trazodone medication.Your recent chest x-ray or CT scan of the chest didn't show any significant problems that could be causing your persistent cough, according to the main doctor in charge.You used to smoke a lot, smoking more than 20 packs of cigarettes per year.
Research Study Groups:
This trial has the following groups:- Group 1: Duloxetine and Placebo
- Group 2: Duloxetine dose escalation
- Group 3: Amitriptyline and Placebo
- Group 4: Amitriptyline dose escalation
- Group 5: Placebo
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic Rochester
What portion of applicants met pre-screening criteria?
Met criteria
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