Phase 2 Interstitial Lung Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with interstitial lung disease (a group of conditions that cause scarring or inflammation in the lungs), according to established medical guidelines
• People who have had a persistent cough for at least 3 months before the initial screening visit
• People who have been on a stable treatment plan for their lung disease for at least 3 months before joining, and who are able to continue that treatment during the study
• People whose cough is rated as at least 40 out of 100 on a cough severity scale at the screening visit (confirm with trial site)
• Women who could become pregnant must agree to use 2 approved forms of birth control and not donate eggs from the screening visit through the end of the 8-week study
• Men with partners who could become pregnant must agree to use 2 approved forms of birth control (at least one of which must be a barrier method) and not donate sperm from screening until 3 months after the last dose of the study drug
• People who have given written consent to participate
• People who are willing and able to follow all parts of the study plan

Who may not be able to join:

• People who currently smoke cigarettes, e-cigarettes, or marijuana, or who have smoked within the past 12 months
• Former smokers with more than a 20 pack-year smoking history (a measure of long-term smoking, confirm with trial site)
• People who are currently taking a type of blood pressure medication called an ACE inhibitor, where that medication is considered a likely cause of their cough, or who have taken one within 12 weeks before screening
• People who have had a respiratory tract infection or a significant change in their lung condition within 4 weeks before screening
• People who have been prescribed opioid medications specifically for chronic cough within 2 weeks before screening (opioids prescribed for other reasons, such as pain, are permitted)
• People who have been prescribed a medication called baclofen specifically for chronic cough within 2 weeks before screening (baclofen prescribed for other reasons is permitted)
• People whose chronic cough has another untreated or poorly managed cause besides their lung disease — for example, uncontrolled asthma, acid reflux, or post-nasal drip — as determined by their treating doctor
• People who need to take any of the medications listed as prohibited during the study (confirm full list with trial site)
• People currently taking part in another experimental treatment study (other than COVID vaccines or certain COVID antibody treatments)
• People who have participated in another clinical trial that does not allow co-enrolment within 4 weeks before screening
• People with significantly elevated liver enzyme levels or high bilirubin levels found during screening blood tests (confirm specific values with trial site)
• People with severely reduced kidney function, or who are on kidney dialysis
• People with advanced liver disease, including cirrhosis or signs of high blood pressure in the liver's blood vessels
• People with a history of allergic reaction or serious intolerance to either duloxetine or amitriptyline — however, people who have previously taken either of these medications and tolerated them may still be considered eligible
• People who are currently pregnant or breastfeeding
• People with any other medical condition or disability that the investigators believe could affect the safety or results of the trial
• People who have a major surgery or other activity planned during the study that would prevent them from completing the required assessments
• People currently taking certain antidepressant medications (SSRIs, SNRIs, or MAO inhibitors) that cannot safely be stopped at least 2 weeks before the screening period
• People who were previously prescribed either amitriptyline or duloxetine specifically for chronic cough, unless that medication was stopped at least 12 weeks before the screening visit
• People who are currently taking certain cough-related treatments including dextromethorphan, guaifenesin, benzonatate, trazodone, pregabalin or gabapentin for cough, certain medicated lozenges or nebulised solutions for cough, or any tricyclic antidepressants (confirm full prohibited medications list with trial site)

Important: Always verify eligibility with the trial site directly before applying.