An Efficacy and Safety Study to Assess an Inhaled, Fixed-dose, Budesonide/Formoterol Fumarate in Participants Aged 4 to Less Than 12 Years of Age With Moderate Persistent Asthma (SOLAIR)

Inclusion Criteria:

• Have a documented clinical diagnosis of asthma as defined by the American Thoracic Society (ATS) for at least 6 months prior to Visit 1a.
• Had no asthma exacerbations requiring an escalation of inhaled medication regimen, systemic corticosteroids or hospitalization in the 6 months prior to Visit 1a.
• Body mass index (BMI) ≤95 percentile for age and sex.
• Female participants who have reached menarche must have a negative urine pregnancy test at all study site visits.
• If receiving immunotherapy per injection or sublingual, a participant must have been on a stable maintenance regimen for at least 6 weeks and be expected to remain on immunotherapy throughout the study.
• Require and are prescribed treatment with a consistent daily dose of inhaled ICS with or without LABA for at least 4 weeks prior to Visit 1a with doses including: Beclometasone dipropionate >200-400 μg/day (standard particle) or >100-200 μg/day (extra fine), BD dipronponate [dry-powder inhaler (DPI), or pressurized metered dose inhaler (pMDI), standard particle, hydrofluoroalkane (HFA)] >200 to 400 μg/day or BD (nebules) >500 to 1000 μg/day, Ciclesonide >80-160 μg/day, Fluticasone furoate 50 μg/day, Fluticasone propionate >100-200 μg/day, or Mometasone furoate 100 μg/day.
• Site-measured FEV1 at morning pre-bronchodilator visit must be ≥60% of the predicted normal, taken at least 6 hours after the last inhaled SABA, and at least 48 hours after the last inhaled LABA prior to Visit 1b. At Visit 2, pre-dose morning FEV1 should be ≥60% predicted normal value. Additionally, the FEV1 should not decrease by more than 10% in absolute value [liter [L]) from measurement at Visit 1b.
• Participants must demonstrate bronchodilator reversibility of ≥10% increase in FEV1 within 15-30 minutes after albuterol/salbutamol administration (90/100 μg per inhalation, 4 actuations with spacer) at the study site (repeatable once if initially failed), OR have historical reversibility of ≥10% within 1 year, OR show 10% FEV1 variability between site visits within 12 months with morning pre-bronchodilator FEV1 ≤95% predicted, OR if bronchodilator response is 7-<10% with post-bronchodilator FEV1 <95% predicted, meet at least one of: positive Methacholine Challenge Test (PC20 ≤16 mg/mL), peak expiratory flow (PEF) daily diurnal variability >13% over 2 weeks, positive exercise challenge test (FEV1 decrease >12%), or fractional exhaled nitric oxide ≥20 ppb despite ICS maintenance.
• Demonstrated ability to use any study devices [MDI with or without spacer, peak expiratory flow meter (PEFM)]. Participants aged 4 to 6 years are mandated to use a spacer. Participants older than 6 years of age must demonstrate adequate MDI technique or use a spacer if failed to demonstrate adequate technique after an objective testing.
• Had discontinued use of all asthma medications, including all formulations of β2-agonists, and used only the run-in medication and rescue medication provided since Visit 1b.

Exclusion Criteria:

• Had been hospitalized at least once or required emergency treatment more than once for an asthma-related condition during the 6 months prior to Visit 1a.
• Had any significant disease or disorder (eg, cardiovascular, pulmonary [other than asthma], gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) or other disease or condition generally affecting lung function (eg, prematurity, congenital lung anomalies, tracheoesophageal fistula, bronchiectasis, chronic sinusitis).
• Had a known or suspected hypersensitivity to albuterol/salbutamol, or BD, or FF, and/or their excipients and/or have a severe hypersensitivity to milk proteins.
• Had any clinically relevant abnormal findings in physical examination, vital signs, abnormalities in electrocardiogram (ECG) or laboratory results at Visit 1a/Visit 1b.
• Had a respiratory infection or other viral/bacterial illness or were recovering from such an illness at the time of Visit 2.
• Loss of asthma stability between Visit 1 and Visit 2, characterized by ≥6 inhalations of SABA within any 24-hour period, ≥4 inhalations of SABA within any 4-hour period, night-time awakenings due to asthma on ≥2 nights per week, daytime symptoms on >2 days per week or limitation in normal activity on ≥2 days per week, ≥20% decrease in PEF from screening baseline, or any unscheduled physician, urgent care, or emergency department visit for asthma.
• Have a planned hospitalization at any time during the study.
• Receiving treatment with a β-blocker (including eye-drops).
• Had taken any other monoclonal or polyclonal antibody therapy, for any reason within the 6 months prior to Visit 1b.
• Had been treated with systemic corticosteroids (eg oral, parenteral, or rectal).