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New treatment option for Chronic Obstructive Pulmonary Disease
Official title A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
ClinicalTrials.gov ID: NCT07016412
What this study is testing
What is Ensifentrine 3 mg?
Ensifentrine 3 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic obstructive pulmonary disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 7 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- Males are eligible to participate if they agree to use contraception or abstinence, and refrain from donating fresh unwashed semen during the study...
- Females are eligible to participate if they are not pregnant, breastfeeding and if one of the following conditions apply:
- Not a woman of child-bearing potential OR
- Agrees to follow the contraceptive guidance from screening throughout the study and for at least 30 days post-study
- Agrees not to donate eggs for the purpose of reproduction from screening throughout the study and for at least 30 days post-study
You likely can't join if
- Concomitant clinically significant pulmonary disease other than COPD (i.e., asthma, tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung...
- Within 6 months prior to randomization, a COPD exacerbation requiring hospitalization
- Within 3 months prior to randomization, use of oral or systemic therapies for COPD exacerbations (for example, oral, intravenous, or intramuscular...
- History of life-threatening COPD, including Intensive Care Unit admission and/or requiring intubation
- Severe comorbidities including
- unstable cardiac disease (myocardial infarction within 1 year prior to randomization, unstable angina within 6 months prior to randomization...
See the full eligibility criteria
Who can join
- Males are eligible to participate if they agree to use contraception or abstinence, and refrain from donating fresh unwashed semen during the study and for at least 30 days post-study
- Females are eligible to participate if they are not pregnant, breastfeeding and if one of the following conditions apply:
- Not a woman of child-bearing potential OR
- Agrees to follow the contraceptive guidance from screening throughout the study and for at least 30 days post-study
- Agrees not to donate eggs for the purpose of reproduction from screening throughout the study and for at least 30 days post-study
- Current of former cigarette smokers with a history of smoking ≥ 10 pack years at the time of signing informed consent [number of pack years = (number of cigarettes per day / 20) × number of years smoked (e.g., 20...
- people with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD
- A score of ≥ 2 on the Modified Medical Research Council (mMRC) Dyspnea Scale at the Screening Visit
- Post-bronchodilator (4 puffs of albuterol) spirometry during the Screening Period demonstrating both the following:
- FEV1/forced vital capacity (FVC) ratio of \< 0.70 AND
- FEV1 ≥ 30 % and ≤ 70% of predicted normal
- A posterior-anterior chest x-ray (CXR) during the Screening Period or within 12 months of signing the Informed Consent Form (ICF) showing no clinically significant abnormalities unrelated to COPD. If a CXR within the...
- people on no maintenance/background therapy or people on stable maintenance as either long-acting β2-agonist (LABA) or long-acting β2-agonist/Inhaled corticosteroid (LABA/ICS) therapy are eligible. people taking...
- Capable of withholding from short-acting bronchodilators for 4 hours prior to spirometry testing. people receiving maintenance therapy with a LABA or LABA/ICS must be capable of withholding twice-daily maintenance...
- Capable of using the study jet nebulizer correctly
- Ability to perform acceptable spirometry in accordance with ATS/ERS guidelines
- Willing and able to attend all study visits and adhere to all study assessments and procedures
What rules you out
- Concomitant clinically significant pulmonary disease other than COPD (i.e., asthma, tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnea (unless controlled with...
- Within 6 months prior to randomization, a COPD exacerbation requiring hospitalization
- Within 3 months prior to randomization, use of oral or systemic therapies for COPD exacerbations (for example, oral, intravenous, or intramuscular glucocorticoids, antibiotics, theophylline, and roflumilast)
- History of life-threatening COPD, including Intensive Care Unit admission and/or requiring intubation
- Severe comorbidities including
- unstable cardiac disease (myocardial infarction within 1 year prior to randomization, unstable angina within 6 months prior to randomization, unstable or life-threatening arrhythmia requiring intervention within 3...
- any other clinically significant medical conditions including uncontrolled diseases (e.g., endocrine, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, psychiatric [e.g. untreated...
- History of or clinically significant on-going bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within 6 months prior to randomization
- History of narrow angle glaucoma
- History of hypersensitivity or intolerance to aerosol medications, albuterol, ensifentrine, or glycopyrrolate or any of its excipients/components, anticholinergic agents, or sympathomimetic amines
- History of or current malignancy of any organ system, treated or untreated within the 5 years prior to randomization, except for localized basal or squamous cell carcinoma of the skin
- Other significant psychiatric disease that would likely result in the subject not being able to complete the study, in the opinion of the Investigator
- Findings on physical examination that an investigator considers to be clinically significant or abnormal during the Screening Period including hematology, biochemistry, viral serology, and ECG
- Prior or current use of Ohtuvayre (ensifentrine)
- Previous lung resection or lung reduction surgery within 1-year of randomization
- Long term oxygen use defined as oxygen therapy prescribed for greater than 12 hours per day. As needed oxygen use (≤ 12 hours per day) is not exclusionary
- Pulmonary rehabilitation unless such treatment has been stable from 4 weeks prior to signing the ICF and plans to remain stable during the study. Pulmonary rehabilitation programs should not be started or completed...
- Major surgery (requiring general anesthesia) in the 6 weeks prior randomization, lack of full recovery from surgery at randomization, or planned surgery through the end of the study
- Current or history of drug or alcohol abuse within the 5 years prior to randomization
- Estimated glomerular filtration rate (eGFR) \< 30 mL/min as tested during the Screening Period
- Alanine aminotransferase (ALT) ≥ 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≥ 2 × ULN, alkaline phosphatase and/or total bilirubin \> 1.5 × ULN (people with Gilbert's syndrome can be included with...
- Use of an experimental drug within 30 days or 5 half-lives of signing the ICF, whichever is longer, and/or participation in a study treatment-free follow-up phase of a clinical study within 30 days prior to signing the...
- Use of an experimental medical device or participation in a follow-up phase of an experimental medical device clinical study within 30 days prior to informed consent
- Affiliation with the investigator site, including an Investigator, Sub-Investigator, study coordinator, study nurse, other employee of participating investigator or study site or a family member of the aforementioned
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Northridge, California, United States
- Sacramento, California, United States
- Clearwater, Florida, United States
- Fleming Island, Florida, United States
- Orlando, Florida, United States
- Ormond Beach, Florida, United States
- Port Orange, Florida, United States
- Tampa, Florida, United States
- Columbus, Georgia, United States
- Rincon, Georgia, United States
- Hammond, Indiana, United States
- Valparaiso, Indiana, United States
- Rockville, Maryland, United States
- Southfield, Michigan, United States
- Plymouth, Minnesota, United States
- Saint Charles, Missouri, United States
- St Louis, Missouri, United States
+ 32 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 7 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dothan, Alabama, United States; Phoenix, Arizona, United States; Los Angeles, California, United States; Northridge, California, United States; Sacramento, California, United States; Clearwater, Florida, United States and 46 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.