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Duloxetine and Amitriptyline in Interstitial Lung Disease-related Cough
NCT05120934Phase 2
Key facts
- Status
- Recruiting
- Start
- Nov 2021
- Primary completion
- Oct 2026
- Countries
- 1
- Sponsor
- Mayo Clinic
- Modality
- Small Molecules
- Conditions
- chronic cough
01
Overview
Phase 2, randomised, double-blind trial of duloxetine and amitriptyline in chronic cough (5 arms), sponsored by Mayo Clinic. Primary endpoint: Change in awake objective cough frequency at 8 weeks. Started Nov 2021; status: recruiting.
02
Design
5 arms- Study design
- RandomizedDouble-blind
Duloxetine and Placebo
30mg Duloxetine for 4 weeks, then 30mg Duloxetine + 30mg Placebo for 4 weeks
Duloxetine dose escalation
30mg Duloxetine for 4 weeks, then 60mg Duloxetine for 4 weeks
Amitriptyline and Placebo
25mg Amitriptyline for 4 weeks, then 25mg Amitriptyline + 25mg Placebo for 4 weeks
Amitriptyline dose escalation
25mg Amitriptyline for 4 weeks, then 50mg Amitriptyline for 4 weeks
Placebo
30mg Placebo for 4 weeks, then 60mg Placebo for 4 weeks
03
Who it enrols
Patients with interstitial lung disease and chronic cough for at least 3 months, on stable ILD-directed therapies, excluding those on certain prohibited medications or with severe liver/kidney impairment.
04
Endpoints
Primary
Change in awake objective cough frequency
Secondary
Change in 24-Hour cough frequency
Change in Cough Severity Diary score
Leicester Cough Questionnaire
Cough Severity Visual Analogue Scale
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