Phase 2 COPD 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:

• Male participants who agree to use contraception or abstinence, and to avoid donating semen during the study and for at least 30 days after it ends
• Female participants who are not pregnant or breastfeeding, and who either are not able to become pregnant, or who agree to use contraception and avoid donating eggs during the study and for at least 30 days after it ends
• People who currently smoke or used to smoke cigarettes, with a smoking history of at least 10 pack-years (for example, one pack per day for 10 years, or half a pack per day for 20 years); former smokers must have stopped at least 6 months before joining
• People who have been diagnosed with COPD (a chronic lung condition) according to established medical guidelines, with symptoms consistent with that diagnosis
• People whose breathlessness scores at least 2 out of 4 on a standard medical scale called the mMRC Dyspnea Scale at the screening visit
• People whose breathing test results, taken after using a reliever inhaler, show a specific pattern of airflow limitation consistent with moderate-to-severe COPD (confirm with trial site for exact numbers)
• People who have had a chest X-ray, or in some cases a CT scan, within the past 12 months showing no significant abnormalities unrelated to COPD
• People who are either not using any regular COPD maintenance medication, or who have been on a stable long-acting inhaler (LABA or LABA/ICS combination) for at least 60 days before joining and agree to continue that medication throughout the trial
• People who are able to stop using short-acting reliever inhalers for 4 hours before breathing tests, and able to pause their regular maintenance inhaler for 24 to 48 hours before certain tests (depending on how often it is taken)
• People who are able to correctly use the type of inhaler device (jet nebulizer) used in this study
• People who are able to perform breathing tests correctly according to standard guidelines
• People who are willing and able to attend all study visits and follow all study procedures

Who may not be able to join:

• People who have a significant lung condition other than COPD, such as asthma, tuberculosis, lung cancer, lung fibrosis, sleep apnea not controlled with a CPAP machine, or certain other lung diseases
• People who were hospitalised for a COPD flare-up (worsening) within the 6 months before joining the trial
• People who used oral or injected steroid medicines, antibiotics, or certain other COPD treatments for a flare-up within the 3 months before joining
• People who have had a life-threatening COPD episode requiring admission to an intensive care unit or a breathing tube
• People with serious heart conditions, such as a heart attack in the past year, unstable chest pain, a dangerous heart rhythm problem in the past 3 months, or severe heart failure
• People with other serious uncontrolled medical conditions — such as liver, kidney, neurological, psychiatric, or other significant diseases — that the study doctor believes would make participation unsafe
• People who have a history of significant blockage of urine flow from the bladder, or who needed a catheter for this reason within the past 6 months
• People who have a history of a specific type of eye condition called narrow angle glaucoma
• People who have had an allergic reaction or intolerance to inhaled medicines, or to any of the specific medications used in this study (including ensifentrine or glycopyrrolate)
• People who have had cancer of any kind within the past 5 years, with the exception of certain minor skin cancers
• People with a psychiatric condition that the study doctor believes would prevent them from completing the study
• People with abnormal results from physical examination, blood tests, or heart tracing (ECG) during the screening period, as judged by the study doctor
• People who have previously used or are currently using the study drug Ohtuvayre (ensifentrine)
• People who have had lung removal or lung reduction surgery within 1 year before joining
• People who use supplemental oxygen for more than 12 hours per day
• People currently in a pulmonary rehabilitation programme that has not been stable for at least 4 weeks before joining, or who plan to start or finish such a programme during the study
• People who had major surgery requiring general anaesthesia within 6 weeks before joining, have not fully recovered from surgery, or have planned surgery before the study ends
• People with a history of drug or alcohol misuse within the past 5 years
• People whose kidney function test results fall below a certain level during screening (confirm with trial site)
• People whose liver function blood test results are significantly above the normal range during screening (confirm with trial site; a specific inherited condition called Gilbert's syndrome may be considered separately)
• People who have taken part in another clinical drug trial within 30 days before joining, or who are still in a follow-up phase of a previous trial
• People who have used an experimental medical device within 30 days before joining, or who are in a follow-up phase of a medical device study
• People who work at the trial site, or who are a close family member of someone who does

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