Phase 2 Chronic Rhinosinusitis 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:

• You have had a chronic cough that has not responded to treatment, or a cough with no known cause, for at least one year, as diagnosed using standard medical guidelines.
• A chest X-ray or CT scan of your chest taken within the past year shows no abnormality that is thought to be causing your cough.
• Your cough is rated at least 40 out of 100mm on a cough severity scale at the start of the study.
• If you are a woman who could become pregnant, you must agree to use 2 acceptable forms of birth control and not donate eggs during the 8-week study period.
• If you are a man whose partner could become pregnant, you must use 2 acceptable forms of birth control (at least one must be a barrier method, such as a condom) and not donate sperm until 3 months after your last dose of study medication.
• You have signed a written consent form agreeing to take part in the trial.
• You are willing and able to follow all parts of the study plan.

Who may not be able to join:

• You currently smoke cigarettes, e-cigarettes, or marijuana, or you have smoked within the past 12 months.
• You are a former smoker with a history of more than 20 pack-years of smoking (confirm with trial site).
• You are currently taking or have taken a type of blood pressure medication called an ACE-inhibitor within the past 12 weeks, especially if it may be causing your cough.
• Your lung function test shows a certain breathing measurement (FEV1/FVC) below 60%, indicating significant airflow limitation (confirm with trial site).
• You have had a respiratory tract infection or a significant change in your lung condition within the past 4 weeks.
• You have used opioid medications (such as codeine) specifically prescribed for your cough within the past 2 weeks.
• You have used a medication called baclofen specifically prescribed for your cough within the past 2 weeks.
• You have been diagnosed with COPD, bronchiectasis, interstitial lung disease, or cystic fibrosis.
• Your chronic cough has a known cause that has not been properly treated, such as uncontrolled asthma, acid reflux, or post-nasal drip.
• You are currently taking certain medications that are not allowed during the study (confirm the full list with the trial site).
• You are currently taking part in another experimental treatment study (not including COVID vaccines or related treatments).
• You have participated in another clinical trial that does not allow joining additional trials within the past 4 weeks.
• Your recent blood tests show that your liver enzyme levels are more than 3 times the normal upper limit.
• Your kidney function is severely reduced, or you are currently on kidney dialysis (confirm with trial site).
• You have advanced liver disease, such as cirrhosis or signs of serious liver complications.
• You have previously had a bad reaction or intolerance to the medications duloxetine or amitriptyline (however, if you have taken either of these before and tolerated them well, you may still be eligible).
• You are currently pregnant or breastfeeding.
• You have a medical condition or disability that the study doctors believe could interfere with the study results or put your safety at risk.
• You have a major surgery or other commitment planned during the study that would prevent you from attending required study visits.
• You are currently taking an SSRI, SNRI, or MAO inhibitor antidepressant that you cannot safely stop at least 2 weeks before the study begins.
• You are currently taking any of a specific list of medications used to treat cough or certain antidepressants, including (but not limited to) dextromethorphan, gabapentin or pregabalin for cough, certain antidepressants, or MAO inhibitors (confirm the full list with the trial site).

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