Actively Recruiting
A Phase II, Randomized, Double-blind, 3-Period Cross-over Study to Assess the Safety and Efficacy of Glycopyrronium Versus Placebo in Children Aged 4 to Less Than 12 Years With Asthma Receiving Budesonide and Formoterol Fumarate
Led by AstraZeneca · Updated on 2026-04-22
69
Participants Needed
39
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating two different doses of inhaled Glycopyrronium (GP) delivered by metered-dose inhaler (MDI) as add-on treatments to Budesonide and Formoterol Fumarate (BFF) MDI in children aged 4 to less than 12 years with asthma. This Phase II, multi-center, randomized, double-blind, crossover study aims to assess how these doses affect lung function compared to a placebo MDI added to BFF MDI. The study is designed to better understand the potential benefits and safety of these treatments in this young population with asthma. Participants will undergo a 3-week run-in period followed by three 3-week treatment periods. During the treatment periods, each participant will receive three treatments in different sequences: BFF MDI combined with GP MDI Dose A, BFF MDI combined with GP MDI Dose B, and BFF MDI combined with placebo MDI. GP MDI and BFF MDI are both administered twice daily by oral inhalation. The study concludes with a safety follow-up visit 12 to 16 days after the last dose. Throughout the study, lung function will be closely monitored, with the primary outcome being the change from baseline in forced expiratory volume in one second (FEV1) at 1-hour post-dose at the end of each 3-week treatment period. Additional measures include morning pre-dose trough FEV1 changes. Participants will attend scheduled visits for assessments, including lung function tests and safety evaluations, ensuring detailed monitoring of treatment effects and participant well-being during the study period.
CONDITIONS
Brief Title
A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared to BFF in Participants of 4 to Less Than 12 Years of Age With Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a documented history of physician-diagnosed asthma
- Use stable and regular inhaled corticosteroid plus one additional asthma controller medication
- Childhood Asthma Control Test score 19 or higher
- Pre-bronchodilator FEV1 of 95% or less of predicted normal value
- Body weight of 14 kg or higher and BMI at or below the 95th percentile for age
- Female participants who have started menstruation must have a negative urine pregnancy test
- No asthma medications other than run-in BFF MDI twice daily and albuterol/salbutamol as needed
You will not qualify if you...
- History of life-threatening asthma episodes requiring intubation or associated with severe complications
- Clinically significant diseases such as cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary conditions
- Clinically relevant abnormal findings in physical exam, lab tests, vital signs, or ECG
- Recent hospitalization for asthma
- Untreated narrow-angle glaucoma or bladder dysfunction where anticholinergic treatment is contraindicated
- Use of long-acting muscarinic antagonists (LAMA) or systemic beta-blockers
- Respiratory infection requiring antibiotics
- Use of systemic corticosteroids for any reason
- Known hypersensitivity to beta 2-agonists, corticosteroids, anticholinergics, or any MDI component
- Inability to withhold short-acting bronchodilators and other asthma medications
- Use of marketed or investigational biologic treatments for asthma
- Regular use of nebulizers for asthma medication
- Use of immunomodulators or immunosuppressive medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants undergo a 3-week run-in period to stabilize on inhaled corticosteroid and formoterol therapy before starting study treatments.
1 visit at start of run-in and 1 visit at end of run-in
Duration - 9 weeks total (3 periods of 3 weeks each)
Participants receive three 3-week treatment periods of different inhaled medications in random order as add-on therapy to their baseline inhaler.
3 visits (one at the end of each 3-week treatment period)
Duration - 12 to 16 days
Participants attend a safety follow-up visit 12 to 16 days after the last dose of study treatment to monitor any adverse effects.
1 visit (in-person)
Trial Site Locations
Total: 39 locations
1
Research Site
Bakersfield, California, United States, 93301
Not Yet Recruiting
2
Research Site
Long Beach, California, United States, 90806
Not Yet Recruiting
3
Research Site
San Diego, California, United States, 92123
Not Yet Recruiting
4
Research Site
Miami, Florida, United States, 33125
Not Yet Recruiting
5
Research Site
Pembroke Pines, Florida, United States, 33026
Not Yet Recruiting
6
Research Site
Owensboro, Kentucky, United States, 42301
Actively Recruiting
7
Research Site
Lafayette, Louisiana, United States, 70508
Not Yet Recruiting
8
Research Site
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
9
Research Site
Columbia, Missouri, United States, 65203
Not Yet Recruiting
10
Research Site
Cincinnati, Ohio, United States, 45229
Not Yet Recruiting
11
Research Site
Oklahoma City, Oklahoma, United States, 73120
Not Yet Recruiting
12
Research Site
Buenos Aires, Argentina, C1122
Not Yet Recruiting
13
Research Site
CABA, Argentina, 1426
Not Yet Recruiting
14
Research Site
La Plata, Argentina, B1900AXI
Not Yet Recruiting
15
Research Site
Lanús Este, Argentina, B1824KAJ
Not Yet Recruiting
16
Research Site
Lobos, Argentina, 7240
Not Yet Recruiting
17
Research Site
Mar del Plata, Argentina, B7600
Not Yet Recruiting
18
Research Site
Mendoza, Argentina, 5500
Not Yet Recruiting
19
Research Site
Mendoza, Argentina, M5500
Not Yet Recruiting
20
Research Site
Rosario, Argentina, 2000
Not Yet Recruiting
21
Research Site
Rosario, Argentina, S2000CVD
Not Yet Recruiting
22
Research Site
San Juan Bautista, Argentina, 1888
Not Yet Recruiting
23
Research Site
Santa Fe, Argentina, 3000
Not Yet Recruiting
24
Research Site
Brno, Czechia, 65691
Not Yet Recruiting
25
Research Site
Prague, Czechia, 15006
Not Yet Recruiting
26
Research Site
Debrecen, Hungary, 4032
Not Yet Recruiting
27
Research Site
Orosháza, Hungary, 5900
Not Yet Recruiting
28
Research Site
Szeged, Hungary, 6720
Not Yet Recruiting
29
Research Site
Székesfehérvár, Hungary, 8000
Not Yet Recruiting
30
Research Site
Szigetvár, Hungary, 7900
Not Yet Recruiting
31
Research Site
Apodaca, Mexico, 64620
Not Yet Recruiting
32
Research Site
Guadalajara, Mexico, 44130
Not Yet Recruiting
33
Research Site
San Juan, Mexico, 00909
Not Yet Recruiting
34
Research Site
Lodz, Poland, 90-329
Not Yet Recruiting
35
Research Site
Tarnów, Poland, 33-100
Not Yet Recruiting
36
Research Site
Belgrade, Serbia, 11000
Not Yet Recruiting
37
Research Site
Belgrade, Serbia, 11040
Not Yet Recruiting
38
Research Site
Belgrade, Serbia, 11070
Not Yet Recruiting
39
Research Site
Novi Sad, Serbia, 21000
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
6
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