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

Exclusion Criteria14

• 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.