Actively Recruiting
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma
Led by Novartis Pharmaceuticals · Updated on 2026-03-30
42
Participants Needed
23
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of asthma for at least 6 months
- Signed informed consent by parent(s)/legal guardian(s) and assent by the child when required
- Child on stable dose of inhaled low-to-medium dose inhaled corticosteroids with one additional controller for at least 4 weeks before run-in
- Pre-bronchodilator FEV1 between 60% and 90% of predicted normal at run-in and randomization
- Demonstrated reversibility of FEV1 by at least 12% after short-acting bronchodilator during run-in
- Able to correctly use Diskus/Accuhaler inhalers before run-in and Breezhaler before randomization
- Parent/legal guardian able to complete e-Diary entries and attend all clinic visits
- Parents/legal guardians willing and able to assist with study procedures and medication compliance
- Female children of child-bearing potential informed about pregnancy prevention and contraception use during the study
You will not qualify if you...
- Use of systemic corticosteroids within 3 months before run-in
- Use of low to medium dose inhaled corticosteroids alone without additional controller
- Needing six or more puffs of rescue medication per day for more than two consecutive days in 4 weeks before screening or run-in
- Asthma attack requiring systemic corticosteroids, hospitalization, or emergency visit within 3 months before screening, or more than 3 exacerbations in 12 months before screening
- Known narrow-angle glaucoma, bladder dysfunction, bladder outlet obstruction, or other contraindications to anticholinergic treatment
- History of long QT syndrome or prolonged QT interval greater than 450 msec confirmed before randomization
- Active or unresolved infections of respiratory tract, sinus, or middle ear within 6 weeks before screening
- History of Type I diabetes or uncontrolled Type II diabetes
- Sexually active at screening
- Hemoglobin levels outside normal ranges at run-in
- Female children of childbearing potential not agreeing to abstinence or contraception as required
- Additional protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
Novartis Investigative Site
Rousse, Bulgaria, 7002
Actively Recruiting
2
Novartis Investigative Site
Sevlievo, Bulgaria, 5400
Actively Recruiting
3
Novartis Investigative Site
Sofia, Bulgaria, 1510
Actively Recruiting
4
Novartis Investigative Site
Ibague, Tolima Department, Colombia, 730006
Actively Recruiting
5
Novartis Investigative Site
Guatemala City, GTM, Guatemala, 01010
Withdrawn
6
Novartis Investigative Site
Guatemala City, Guatemala, 01015
Actively Recruiting
7
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary, 4032
Actively Recruiting
8
Novartis Investigative Site
Budapest, Hungary, 1033
Actively Recruiting
9
Novartis Investigative Site
Budapest, Hungary, H-1083
Actively Recruiting
10
Novartis Investigative Site
Eger, Hungary, 3300
Actively Recruiting
11
Novartis Investigative Site
Kaposvár, Hungary, 7400
Withdrawn
12
Novartis Investigative Site
Nagykanizsa, Hungary, 8800
Withdrawn
13
Novartis Investigative Site
Szigetvár, Hungary, 7900
Actively Recruiting
14
Novartis Investigative Site
Tarnów, Poland, 33-100
Actively Recruiting
15
Novartis Investigative Site
Lodz, Łódź Voivodeship, Poland, 90-329
Actively Recruiting
16
Novartis Investigative Site
George, Western Cape, South Africa, 6529
Actively Recruiting
17
Novartis Investigative Site
Cape Town, South Africa, 7531
Actively Recruiting
18
Novartis Investigative Site
Esplugues, Barcelona, Spain, 08950
Actively Recruiting
19
Novartis Investigative Site
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
20
Novartis Investigative Site
Mérida, Extremadura, Spain, 06800
Withdrawn
21
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
22
Novartis Investigative Site
London, United Kingdom, SE5 9RS
Actively Recruiting
23
Novartis Investigative Site
Stoke-on-Trent, United Kingdom, ST4 6QG
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here