Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-04-22
69
Participants Needed
39
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the effect of 2 different GP metered dose inhaler (MDI) doses relative to placebo MDI as add-on treatment to BFF MDI on lung function in participants 4 to less than 12 years of age with asthma.
CONDITIONS
Official 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 aged 4 to less than 12 years with physician-diagnosed asthma
- Using stable inhaled corticosteroid plus one additional asthma controller medication
- Childhood Asthma Control Test score of 19 or higher
- Pre-bronchodilator FEV1 less than or equal to 95% of predicted normal
- Body mass index at or below the 95th percentile for age and body weight of at least 14 kg
- 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...
- Life-threatening asthma with history of intubation or severe asthma episodes
- Significant diseases including cardiovascular, liver, kidney, blood, neurological, endocrine, gastrointestinal, or lung conditions
- Abnormal physical exam, clinical chemistry, hematology, vital signs, or ECG findings
- Recent hospitalization for asthma
- Untreated or inadequately treated narrow-angle glaucoma, bladder problems, or other anticholinergic contraindications
- Use of long-acting muscarinic antagonists (LAMA) alone or in combination inhalers
- Current use of systemic beta-blockers
- Recent respiratory infection needing antibiotics
- Use of systemic corticosteroids for any reason
- Hypersensitivity to beta 2-agonists, corticosteroids, anticholinergics, or inhaler components
- Unable to withhold short-acting bronchodilators or other asthma medications
- Use of marketed or investigational biologics for asthma
- Regular use of nebulizer treatments at home
- Use of immunomodulators or immunosuppressive medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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