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

Inclusion Criteria

• Main 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.