Mayo Clinic
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.
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…
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…
25 mg orally for 4 weeks
50 mg orally for 4 weeks
30mg orally for 4 weeks
60mg orally for 4 weeks
30mg tablet with no active study ingredient for 4 weeks
60mg tablet with no active study ingredient for 4 weeks
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