A Randomized, Double-blind, Placebo Controlled, Dose Escalation Pilot Study Evaluating the Efficacy of Two Doses of Duloxetine and Amitriptyline in Interstitial Lung Disease-related Cough
Mayo Clinic
Summary
This research study is evaluating the effectiveness of escalating doses of Amitriptyline and Duloxetine in reducing cough frequency in patients with interstitial lung disease (ILD)-related cough.
Description
This is a randomized, double-blind, placebo-controlled, parallel-arm, dose escalation study of Duloxetine \& Amitriptyline in subjects with interstitial lung disease-related chronic cough. Subjects will be screened during a period of up to 2 week and will undergo screening/ baseline cough monitoring. A total of 25 subjects who meet entry criteria will be randomly assigned in a 1: 1: 1: 1: 1 ratio to one of five treatment arms using stratified randomization in blocks of 5. Each arm will have two successive 4-week treatment periods (Blinded Period 1 \& 2). After this, patients will be unblinded…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Have a diagnosis of interstitial lung disease according to the American Thoracic Society Guidelines * Have a chronic cough for at least 3 months prior to the screening visit * Patients should be on a stable dose of ILD-directed therapies for 3 months prior to enrollment and will be allowed to continue their ILD-directed therapies. These include -but are not limited to- corticosteroids, immunosuppressing agents such as azathioprine and mycophenolate, as well as antifibrotic medications including nintedanib and pirfenidone. Additional corticosteroids and adjustment of ILD-d…
Interventions
- DrugAmitriptyline 25 MG
25 mg orally for 4 weeks
- DrugAmitriptyline 50 MG
50 mg orally for 4 weeks
- DrugDuloxetine 30 MG
30mg orally for 4 weeks
- DrugDuloxetine 60 MG
60mg orally for 4 weeks
- DrugPlacebo 30 MG
30mg tablet with no active study ingredient for 4 weeks
- DrugPlacebo 60 MG
60mg tablet with no active study ingredient for 4 weeks
Location
- Mayo Clinic in RochesterRochester, Minnesota