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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
Chest radiograph or computed tomography (CT) of the thorax within the last 1 year not demonstrating any abnormality considered to be significantly contributing to the refractory chronic cough in the opinion of the Principal Investigator
Have a diagnosis of refractory chronic cough or unexplained cough for at least one year according to the American College of Chest Physicians guidelines
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.

Eligible Conditions
  • Chronic Cough

MACS-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.
Select...
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.

MACS-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks, 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks, 8 weeks for reporting.

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 more

MACS-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
3,175 Previous Clinical Trials
3,758,111 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

Amitriptyline (Tricyclic Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT05110144 — Phase 2
Chronic Cough Research Study Groups: Duloxetine and Placebo, Duloxetine dose escalation, Amitriptyline and Placebo, Amitriptyline dose escalation, Placebo
Chronic Cough Clinical Trial 2023: Amitriptyline Highlights & Side Effects. Trial Name: NCT05110144 — Phase 2
Amitriptyline (Tricyclic Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05110144 — Phase 2

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
~15 spots leftby Mar 2025