A Phase IIb, Randomized, Double-blind, Placebo- Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ensifentrine-glycopyrrolate Fixed-dose Combination at Two Dose Levels Compared to Glycopyrrolate or Ensifentrine Monotherapy in Subjects With COPD
Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA
Summary
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).
Description
Enrolled participants will be expected to participate for approximately 7 weeks: 1 to 2 weeks for screening, 4 weeks of treatment, and 1 week of follow up. Participants will be randomized to one of 6 treatment arms: two fixed dose combinations of ensifentrine (3 mg) and glycopyrrolate (either 21.25 or 42.5 mcg), the 3 individual components as monotherapies, or placebo. All treatments will be administered twice a day via oral inhalation by a standard jet nebulizer. The primary objective of this study is to evaluate the bronchodilator effects of the fixed dose combinations compared to each of th…
Eligibility
- Age range
- 40–80 years
- Sex
- All
- Healthy volunteers
- No
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 a…
Interventions
- DrugEnsifentrine 3 mg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
- DrugGlycopyrrolate 21.25 mcg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
- DrugGlycopyrrolate 42.5 mcg
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
- DrugPlacebo
Administered by a standard jet nebulizer, twice daily for 28 consecutive days
Locations (55)
- SEC Clinical Research, LLCDothan, Alabama
- Elite Clinical Studies, LLCPhoenix, Arizona
- Downtown LA Research Center Inc - ClinEdgeLos Angeles, California
- California Medical Research Associates, Inc.Northridge, California
- Northern California Research CorpSacramento, California
- Clinical Research of West Florida IncClearwater, Florida