A Phase II, Randomized, Double-Blind, Cross-Over Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Single Inhaled Doses of Ensifentrine-Glycopyrrolate Fixed Dose Combination, Ensifentrine, and Glycopyrrolate in Subjects With Chronic Obstructive Pulmonary Disease

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will assess the pharmacokinetics (PK), pharmacodynamics (PD) and safety of ensifentrine and glycopyrrolate fixed dose (FDC) product, the individual components of the FDC (ensifentrine and glycopyrrolate, each in the FDC formulation), ensifentrine 1.5 mg in the FDC formulation and ensifentrine 3 mg in the marketed formulation each administered via a standard jet nebulizer, in adult participants with chronic obstructive pulmonary disease (COPD).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• Males are eligible to participate if they 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 and not to donate eggs for the purpose of reproduction from screening throughout the study and for at least 30 days post-study

• Current or former cigarette smokers with a history of cigarette smoking ≥ 10 pack years as of signing the ICF \[number of pack years = (number of cigarettes per day / 20) × number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)\]. Pipe and/or cigar use cannot be used to calculate pack-year history. Former smokers are defined as those who have stopped smoking for at least 6 months prior to signing the ICF. Smoking cessation programs are permitted during the study

• Subjects 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

• 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 ≥ 40 % and ≤ 80% of predicted normal

• A posterior-anterior chest x-ray (CXR) during the Screening Period or within 12 months prior to signing the ICF showing no clinically significant abnormalities unrelated to COPD. If a CXR within the past 12 months is not available but a computed tomography (CT) scan within the same time period is available, the CT scan may be reviewed in place of a CXR

• Capable of withholding from short-acting bronchodilators for at least 4 hours if using albuterol and for at least 6 hours if using ipratropium prior to pre-dose of blinded study medication spirometry testing

• Anatomical features of peripheral veins that allow the ability to draw sufficient blood volume for all study samples

• Capable of using the study supplied 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

Locations
United States
Florida
Clinical Research of West Florida Inc - Clearwater
RECRUITING
Clearwater
Clinical Research of West Florida Inc - Tampa
RECRUITING
Tampa
Missouri
Midwest Chest Consultants PC
RECRUITING
Saint Charles
South Carolina
Velocity Clinical Research - Spartanburg - PPDS
RECRUITING
Spartanburg
Contact Information
Primary
Verona Pharma Clinical Trials
clinicaltrials@veronapharma.com
Please reach out by email
Time Frame
Start Date: 2025-10-09
Estimated Completion Date: 2026-02-23
Participants
Target number of participants: 30
Treatments
Experimental: Treatment A: Ensifentrine plus Glycopyrrolate
(fixed-dose combination formulation)~Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to
Experimental: Treatment B: Ensifentrine monotherapy
(fixed-dose combination formulation)~Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to
Experimental: Treatment C: Glycopyrrolate monotherapy
(fixed-dose combination formulation)~Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to
Experimental: Treatment D: Ensifentrine monotherapy
(fixed-dose combination formulation)~Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to
Experimental: Treatment E: Ensifentrine monotherapy (marketed formulation)
Subjects will receive a single dose of study medication in each treatment period followed by a 7 to 9-day washout period before receiving the next treatment in the sequence they were assigned to
Sponsors
Leads: Verona Pharma plc

This content was sourced from clinicaltrials.gov

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