NCT07525375 · AstraZeneca
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
(FAROS)
What this study 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.
View original scientific 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 can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants who have a documented history of physician-diagnosed asthma
- Participants who have been using a stable and regular inhaled corticosteroid plus one additional asthma controller medication.
- Participants must have a Childhood Asthma Control Test score ≥ 19.
- Participants must have a pre-bronchodilator FEV1 ≤ 95% of predicted normal value.
- Body mass index (BMI) ≤ 95 percentile for age and body weight of ≥ 14 kg or higher.
- Female participants who experience menarche must have a negative urine pregnancy test.
- Received no asthma medication other than run-in BFF MDI BID and albuterol/salbutamol as needed. Main
Exclusion criteria
- Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
- Historical or current evidence of a clinically significant disease including, but not limited to cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary.
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs, or ECG.
- Hospitalization for asthma
- Narrow-angle glaucoma not adequately treated and/or change in vision, bladder dysfunction, bladder outlet obstruction/urinary retention or any other conditions where anticholinergic treatment is contraindicated and may be relevant.
- Use of Long-acting muscarinic antagonist (LAMA), either alone or as part of an inhaled combination therapy.
- Current use of any systemic beta-blockers.
- Respiratory infection involving antibiotic treatment.
- Systemic corticosteroid use for any reason (including asthma exacerbations).
- Participants with a known hypersensitivity to beta 2-agonists, corticosteroids, anticholinergics, or any component of the MDI.
- Participants who are medically unable to withhold their short-acting bronchodilators and other asthma medications.
- Any use of marketed (eg, omalizumab, mepolizumab, benralizumab, reslizumab) or investigational biologic.
- Regular use of a nebulizer or a home nebulizer for receiving asthma medications.
- Use of any immunomodulators or immunosuppressive medication.
Where
- Bakersfield, California
- Long Beach, California
- San Diego, California
- Miami, Florida
- Pembroke Pines, Florida
- Owensboro, Kentucky
- Lafayette, Louisiana
- Boston, Massachusetts
- Columbia, Missouri
- Cincinnati, Ohio
- Oklahoma City, Oklahoma
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations