Study 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 Refractory Cough
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 4 weeks, 8 weeks
4 weeks, 8 weeks
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
Change in Cough Severity Visual Analogue Scale (VAS)
Change in awake objective cough frequency (at 4 & 8 weeks)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
5 Treatment Groups
Duloxetine and Placebo
1 of 5
Duloxetine dose escalation
1 of 5
Amitriptyline and Placebo
1 of 5
Amitriptyline dose escalation
1 of 5
Placebo
1 of 5
Experimental Treatment
Non-Treatment Group
50 Total Participants · 5 Treatment Groups
Primary Treatment: Duloxetine 30 MG · Has Placebo Group · Phase 2
Duloxetine and PlaceboExperimental Group · 2 Interventions: Duloxetine 30 MG, Placebo 30 MG · Intervention Types: Drug, Drug
Duloxetine dose escalationExperimental Group · 2 Interventions: Duloxetine 30 MG, Duloxetine 60 MG · Intervention Types: Drug, Drug
Amitriptyline and PlaceboExperimental Group · 2 Interventions: Amitriptyline 25 MG, Placebo 30 MG · Intervention Types: Drug, Drug
Amitriptyline dose escalationExperimental Group · 2 Interventions: Amitriptyline 25 MG, Amitriptyline 50 MG · Intervention Types: Drug, Drug
PlaceboPlaceboComparator Group · 2 Interventions: Placebo 30 MG, Placebo 60 MG · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duloxetine
FDA approved
Duloxetine
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks, 8 weeks
Who is running the clinical trial?
Mayo ClinicLead Sponsor
2,958 Previous Clinical Trials
3,449,376 Total Patients Enrolled
Vivek N Iyer, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
25 Total Patients Enrolled
Eligibility Criteria
Age 18 - 75 · All Participants · 23 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are taking opioids, such as tramadol or codeine, to treat a cough.
There is no criterion listed. Please provide more information about the screening criteria for me to rewrite.
You cannot have taken amitriptyline or duloxetine for chronic cough within the 12 weeks prior to the screening.
You are currently taking any experimental drugs or treatments, except for COVID vaccine and COVID-related monoclonal antibody therapy.
You have been experiencing a persistent cough for one year or more and it is not responding to treatment. This follows guidelines set by the American College of Chest Physicians.
This criterion is incomplete and needs more information to be properly summarized. Please provide more context.
You are taking pregabalin or gabapentin for a long-term cough.
You are currently taking nebulized lidocaine for chronic cough.
You are taking certain medications called SNRIs, such as venlafaxine, desvenlafaxine, milnacipran or levomilnacipran.
You are currently taking medication known as an ACE-inhibitor.
I'm sorry, but this is not a complete criterion. Please provide me with more information so I can summarize it for you.
I'm sorry, but "Chlorpheniramine" is not a criterion. It is the name of a medication. Can you please provide more context or information?
There isn't any information provided to rewrite this criterion. It seems to be a single word or name, without any context or explanation.
You are currently using lollipops containing 1% tetracaine to treat a chronic cough.
You are taking certain types of antidepressants called tricyclic antidepressants.
Who else is applying?
What state do they live in?
| Tennessee | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Mayo Clinic Rochester | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |