Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma (NCT05222529)
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.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Novartis Investigative Site — Rousse
Age range: 6 Years to 11 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (23 Sites)
- Novartis Investigative Site — Rousse,
- Novartis Investigative Site — Sevlievo,
- Novartis Investigative Site — Sofia,
- Novartis Investigative Site — Ibague, Tolima Department
- Novartis Investigative Site — Guatemala City, GTM
- Novartis Investigative Site — Guatemala City,
- Novartis Investigative Site — Debrecen, Hajdu Bihar Megye
- Novartis Investigative Site — Budapest,
- Novartis Investigative Site — Budapest,
- Novartis Investigative Site — Eger,
- Novartis Investigative Site — Kaposvár,
- Novartis Investigative Site — Nagykanizsa,
- Novartis Investigative Site — Szigetvár,
- Novartis Investigative Site — Tarnów, Poland
- Novartis Investigative Site — Lodz, Łódź Voivodeship
- Novartis Investigative Site — George, Western Cape
- Novartis Investigative Site — Cape Town,
- Novartis Investigative Site — Esplugues, Barcelona
- Novartis Investigative Site — Sabadell, Barcelona
- Novartis Investigative Site — Mérida, Extremadura
- Novartis Investigative Site — Barcelona,
- Novartis Investigative Site — London,
- Novartis Investigative Site — Stoke-on-Trent,
📞 Contact the Study Coordinator
Phone: +41613241111
Email: novartis.email@novartis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Asthma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.