Efficacy of Two Doses of Duloxetine & Amitriptyline in Interstitial Lung Disease-related Cough (NCT05120934) | Clinical Trial Compass
RecruitingPhase 2
Efficacy of Two Doses of Duloxetine & Amitriptyline in Interstitial Lung Disease-related Cough
United States25 participantsStarted 2021-11-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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-directed therapy doses is permitted if deemed appropriate by the treating physician
* Have a score of ≥ 40mm on the Cough Severity VAS at Screening.
* Women of child-bearing potential must agree to use 2 forms of acceptable birth control and make no donation of eggs from Screening through the end of the 8-week study period. Acceptable birth control methods include established use of oral, injected, or implanted hormonal methods of contraception; intrauterine device (IUD) or intrauterine system (IUS); tubal ligation; or male sterilization. Double-barrier method (diaphragm for female subject and condom for male partner with spermicidal) satisfies the requirement for 2 forms of acceptable birth control. When concordant with the preferred lifestyle of the subject, true and complete abstinence (not periodic abstinence) is acceptable.
* Male subjects and their partners of child-bearing potentia…
What they're measuring
1
Change in awake objective cough frequency (at 4 & 8 weeks)