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

NCT06545500 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-02-09

Study results available
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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

Interventions

DRUG

Glycopyrrolate (85 μg)

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

DRUG

Glycopyrrolate (42.5 μg)

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

DRUG

Glycopyrrolate (14 μg)

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Verona Pharma plc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-16
Primary Completion
2025-01-02
Completion
2025-01-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06545500 on ClinicalTrials.gov