NCT07016412 · Verona Pharma plc
A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD
What this study is about
This study will assess the safety and effectiveness 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).
View original scientific description
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).
Interventions
DRUG
Ensifentrine 3 mg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
DRUG
Glycopyrrolate 21.25 mcg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
DRUG
Glycopyrrolate 42.5 mcg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
DRUG
Placebo
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
Primary outcome measures
Change from baseline in average forced expiry volume in 1 second (FEV1) area under the curve versus time, from time 0 to 4 hours (AUC0-4h)
Time frame: Baseline and Day 28
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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: 1. Not a woman of child-bearing potential OR 2. Agrees to follow the contraceptive guidance from screening throughout the study and for at least 30 days post-study 3. 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 \[number of pack years = (number of cigarettes per day / 20) × number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)\]. Pipe and/or cigar use cannot be used to calculate pack-year history. Forme
Where
- Dothan, Alabama
- Phoenix, Arizona
- Los Angeles, California
- Northridge, California
- Sacramento, California
- Clearwater, Florida
- Fleming Island, Florida
- Orlando, Florida
- Ormond Beach, Florida
- Port Orange, Florida
- Tampa, Florida
- Columbus, Georgia
And 40 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations