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
Recruiting · 39 sites across 8 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Has a documented history of physician-diagnosed asthma
- •Uses a stable and regular inhaled corticosteroid plus one additional asthma controller medication
- •Has a Childhood Asthma Control Test score of 19 or higher (a test score for asthma control)
- •Has a pre-bronchodilator FEV1 of 95% or less of predicted normal value (a breathing test)
- •Has BMI at or below the 95th percentile for age and weight, and body weight of at least 14 kg
🚫 You may not be able to join if…
- •Has life-threatening asthma, including past severe episodes that required intubation and involved hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related fainting
- •Has a clinically significant disease in the past or present, including cardiovascular, liver, kidney, blood, brain/nervous system, hormone/endocrine, stomach/gut, or lung disease
- •Has hospitalization for asthma
- •Has narrow-angle glaucoma that is not adequately treated, or other problems where anticholinergic medicine is not allowed
- •Uses other certain asthma medicines (including LAMA medicines, systemic beta-blockers, systemic corticosteroids, or biologics) or has recent respiratory infection needing antibiotics
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 4–11
- ✓A BMI around 14 or higher
- ✓Have Obesity / overweight or COPD (chronic lung disease) or Asthma
- !Some conditions may not be a fit: Heart / cardiovascular disease
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
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.
Is it safe? Who makes sure of that?+
This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT07525375 · Locations: California · Florida · Kentucky · Louisiana · Massachusetts · Missouri · Ohio · Oklahoma