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Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma

NCT05222529 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-03-30

No results posted yet for this study

Summary

The purpose of this study is to characterize the bronchodilator effect, systemic exposure and safety/tolerability of two different doses of inhaled glycopyrronium, when compared to placebo. Outcome of this study will be used to determine the dose of inhaled glycopyrronium for the development of fixed dose combination indacaterol/mometasone/glycopyrronium (QVM149) for children aged 6 to less than 12 years old with moderate to severe asthma.

Conditions

Interventions

DRUG

Glycopyrronium bromide 25ug

25μg Glycopyrronium bromide capsules for oral inhalation via Breezhaler

DRUG

Placebo

Placebo to Glycopyrronium bromide capsules for oral inhalation via Breezhaler

DRUG

Glycopyrronium bromide 12.5ug

12.5ug Glycopyrronium bromide capsules for oral inhalation via Breezhaler

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-29
Primary Completion
2027-07-30
Completion
2027-08-30

Countries

  • Bulgaria
  • Colombia
  • Guatemala
  • Hungary
  • Poland
  • South Africa
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT05222529 on ClinicalTrials.gov