A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD

NCT06545500 | Completed Phase 2 Results FDA Drug

• 1 other identifier: RPL554-CO-211
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 7

Brief Summary

This study is a randomized, double-blind, placebo-controlled complete block cross-over study designed to assess the efficacy, safety, and pharmacokinetics of 3 dose levels of glycopyrrolate inhalation solution delivered twice daily via standard jet nebulizer over three 1-week active treatment periods and one 1-week placebo period in subjects with chronic obstructive pulmonary disease (COPD).

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)

  Baseline (pre-dose for each treatment period) and Day 7

Secondary Outcomes (10)

• Change From Average Baseline FEV1 to Average Peak FEV1 Measured Over 4 Hours

  Baseline (pre-dose for each treatment period) and Day 7

• Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h)

  Baseline (pre-dose for each treatment period) and Day 7

• Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 12 Hours (AUC0-12h)

  Baseline (pre-dose for each treatment period) and Day 7

• Change From Average Baseline FEV1 to Evening Trough FEV1

  Baseline (pre-dose for each treatment period) and Day 7

• Change From Average Baseline FEV1 to Peak FEV1 Measured Over 4 Hours After First Dose

  Baseline (pre-dose) and Day 1

Study Arms (4)

Dose Level A

EXPERIMENTAL

The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to

Drug: Glycopyrrolate (85 μg)

Dose Level B

EXPERIMENTAL

The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to

Drug: Glycopyrrolate (42.5 μg)

Dose Level C

EXPERIMENTAL

The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to

Drug: Glycopyrrolate (14 μg)

Dose Level D

PLACEBO COMPARATOR

The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to

Drug: Placebo

Interventions

Glycopyrrolate (42.5 μg) DRUG

Administered by a standard jet nebulizer, twice daily for 7 consecutive days

Dose Level B

Glycopyrrolate (14 μg) DRUG

Administered by a standard jet nebulizer, twice daily for 7 consecutive days

Dose Level C

Placebo DRUG

Administered by a standard jet nebulizer, twice daily for 7 consecutive days

Dose Level D

Glycopyrrolate (85 μg) DRUG

Administered by a standard jet nebulizer, twice daily for 7 consecutive days

Dose Level A

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males are eligible to participate if they agree to use contraception from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.
• Females are eligible to participate if they are not pregnant, not breastfeeding, and ≥ 1 of the following conditions apply:
• Not a woman of childbearing potential (WOCBP) OR
• A WOCBP who agrees to follow the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.
• Current or former cigarette smokers with a history of cigarette smoking ≥ 10 pack years at Screening \[number of pack years = (number of cigarettes per day / 20) × number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)\]. 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 Screening. 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 salbutamol) spirometry at Screening 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) at Screening or within 12 months prior to Screening 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 withdrawing from short-acting bronchodilators for 4 hours prior to spirometry testing and from BID LABA ± ICS therapy for 24 hours prior to spirometry.
• Capable of using the study 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.

You may not qualify if:

• 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 stable continuous positive airway pressure \[CPAP\] use), known alpha-1 antitrypsin deficiency, core pulmonale or other non-specific pulmonary disease).
• Within 6 months prior to Screening:
• COPD exacerbation requiring hospitalization.
• Use of therapies for COPD exacerbation (e.g., oral, intravenous, or intramuscular glucocorticoids).
• Lower respiratory tract infection within 6 weeks of Screening or an active infection at Screening.
• History of life-threatening COPD, including Intensive Care Unit admission and/or requiring intubation.
• Previous lung resection or lung reduction surgery within 1-year of Screening.
• Severe comorbidities including unstable cardiac, or any other clinically significant medical conditions including uncontrolled diseases that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject.
• History of or clinically significant on-going bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within the previous 6 months.
• History of narrow angle glaucoma.
• History of hypersensitivity or intolerance to aerosol medications, salbutamol or glycopyrrolate or any of its excipients/components, anticholinergic agents, or sympathomimetic amines.
• Pulmonary rehabilitation unless such treatment has been stable from 4 weeks prior to Screening (Visit 1) and remains stable during the study. Pulmonary rehabilitation programs should not be started or completed during participation in the study.
• Major surgery (requiring general anesthesia) in the 6 weeks prior to Screening, lack of full recovery from surgery at Screening, or planned surgery through the end of the study.
• History of or current malignancy of any organ system, treated or untreated within the past 5 years, except for localized basal or squamous cell carcinoma of the skin.
• Current or history of drug or alcohol abuse within the past 5 years.

Sponsors & Collaborators

• Verona Pharma plc: lead

Study Sites (7)

Clinical Research of West Florida Inc - Clearwater

Clearwater, Florida, 33765, United States

Location

Clinical Research of West Florida Inc - Tampa

Tampa, Florida, 33606, United States

Location

Midwest Chest Consultants PC

Saint Charles, Missouri, 63301, United States

Location

American Health Research Inc

Charlotte, North Carolina, 28277, United States

Location

Velocity Clinical Research - Greenville

Greenville, South Carolina, 29615, United States

Location

Velocity Clinical Research - Spartanburg

Spartanburg, South Carolina, 29303, United States

Location

Velocity Clinical Research - Union

Union, South Carolina, 29379, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Verona Pharma Clinical Trials
• Organization: Verona Pharma plc

clinicaltrials@veronapharma.com

Please reach out by email

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each participant is expected to complete all 4 treatment periods, each consisting of a different dose level of blinded medication depending on the treatment sequence they were assigned to

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: August 16, 2024
• Primary Completion: January 2, 2025
• Study Completion: January 8, 2025
• Last Updated: February 9, 2026
• Results First Posted: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)