RecruitingPhase 2NCT05222529

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

A Phase II, Double-blind, Randomized, Multiple Dose, Cross Over, Three-treatment, Three-period, Six Sequence Placebo Controlled Trial to Evaluate Efficacy, Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety and Tolerability of Glycopyrronium (Bromide) in Children From 6 to Less Than 12 Years of Age With Asthma.

Sponsor

Novartis Pharmaceuticals

Enrollment

42 participants

Start Date

Aug 29, 2022

Study Type

INTERVENTIONAL

Conditions

Asthma

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.

Eligibility

Min Age: 6 YearsMax Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how the body of children aged 6 to under 12 with asthma processes a medication called glycopyrronium bromide — an inhaled bronchodilator that helps open the airways. Researchers want to understand if this drug is safe and works well in this age group. **You may be eligible if...** - Your child is between 6 and under 12 years old - Your child has had a confirmed asthma diagnosis for at least 6 months - Your child is already on a stable dose of inhaled corticosteroids (a common asthma controller medicine) plus at least one other controller medication - A parent or guardian can provide informed consent **You may NOT be eligible if...** - Your child's asthma has been uncontrolled or unstable in the past few months - Your child has other significant lung or heart conditions - Your child has had a serious asthma attack requiring hospitalization recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGlycopyrronium bromide 25ug

25μg Glycopyrronium bromide capsules for oral inhalation via Breezhaler

DRUGPlacebo

Placebo to Glycopyrronium bromide capsules for oral inhalation via Breezhaler

DRUGGlycopyrronium bromide 12.5ug

12.5ug Glycopyrronium bromide capsules for oral inhalation via Breezhaler

Locations(23)

Novartis Investigative Site

Rousse, Bulgaria

Novartis Investigative Site

Sevlievo, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Ibague, Tolima Department, Colombia

Novartis Investigative Site

Guatemala City, GTM, Guatemala

Novartis Investigative Site

Guatemala City, Guatemala

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Eger, Hungary

Novartis Investigative Site

Kaposvár, Hungary

Novartis Investigative Site

Nagykanizsa, Hungary

Novartis Investigative Site

Szigetvár, Hungary

Novartis Investigative Site

Tarnów, Poland

Novartis Investigative Site

Lodz, Łódź Voivodeship, Poland

Novartis Investigative Site

George, Western Cape, South Africa

Novartis Investigative Site

Cape Town, South Africa

Novartis Investigative Site

Esplugues, Barcelona, Spain

Novartis Investigative Site

Sabadell, Barcelona, Spain

Novartis Investigative Site

Mérida, Extremadura, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

London, United Kingdom

Novartis Investigative Site

Stoke-on-Trent, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05222529

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