Table 1

Key inclusion and exclusion criteria

Inclusion criteriaExclusion criteria
Female or male outpatients aged ≥4 yearsOther significant lung disease (eg, COPD, emphysema, bronchiectasis, cystic fibrosis, bronchopulmonary dysplasia)
Diagnosis of asthma per GINA criteria ≥1 year prior to screeningSCS use (any dose and any indication) within 6 weeks of screening
Background maintenance therapy of stable medium-to-high dose ICS or low-to-high dose ICS–LABA with/without one other maintenance medication (LTRA, LAMA or theophylline) for ≥3 months with stable dosing for ≥4 weeks prior to screeningOral corticosteroid use for ≥3 weeks within 3 months of screening
Pre-BD FEV1 ≥40–<90% or ≥60% predicted for those aged ≥18 years and 4–17 years, respectivelyHaving received any marketed (benralizumab, dupilumab, mepolizumab, omalizumab or reslizumab) or investigational biologic within 3 months or 5 half-lives of screening or any other prohibited medication*
Reversible airway obstruction at screening, defined as an increase in FEV1 ≥12% (and ≥200 mL for patients ≥18 years) relative to baseline after inhalation of albuterolCurrent or former smokers (former with either >10 pack-year history or who stopped smoking <6 months prior to screening)
History of ≥1 severe asthma exacerbation in the 12 months prior to screeningCompleted treatment for asthma exacerbation or LRTI within 6 weeks of screening or treated unresolved URTI within 7 days of screening
ACQ-7 score ≥1.5 at screening and ACQ-5 score of ≥1.5 at randomisationHistory of life-threatening asthma episode(s) within 5 years of screening
BMI <40 kg/m2Historical or current evidence of clinically significant disease
Acceptable spirometry performance (ie, meet ATS/ERS acceptability/repeatability criteria)Pregnant, breast feeding or planned pregnancy
Demonstrate acceptable MDI administration technique as assessed by the investigatorCancer not in complete remission for at least 5 years
Acceptable and reproducible PEF measurementsHospitalisation for psychiatric disorder or attempted suicide within 1 year of screening
Use of as-needed Sponsor provided Ventolin medication due to asthma symptoms ≥3 days during the last week of the run-in period before randomisationHistory of psychiatric disease, intellectual deficiency, poor motivation or other conditions if their magnitude is limiting informed consent validity
Significant abuse of alcohol or drugs
  • *Prohibited medications included; oral, parenteral or rectal corticosteroids (except if required to treat severe asthma exacerbation); any other asthma medication except stable doses of maintenance therapy taken at entry into the study and provided by the Sponsor; inhaled disodium cromoglycate or inhaled nedocromil sodium; 5-lipoxygenase inhibitors (ie, zilueton); inhaled anticholinergics; phosphodiesterase inhibitors (ie, roflumilast); beta2-adrenergic blockers including eye-drops; systemic treatment with potent cytochrome P3A4 inhibitors (eg, ketoconazole, itraconazole and ritonavir); non-glucocorticoid-containing nasal sprays.

  • ACQ-5, asthma control 5-point questionnaire; ACQ-7, asthma control 7-point questionnaire; ATS, American Thoracic Society; BD, bronchodilator; BMI, body mass index; COPD, chronic obstructive pulmonary disease; ERS, European Respiratory Society.; FEV1, forced expiratory volume in 1 s; GINA, Global Initiative for Asthma; ICS, Inhaled corticosteroid; LABA, long-acting beta2-agonist; LAMA, long-acting muscarinic antagonist; LRTI, lower respiratory tract infection; LTRA, leukotriene receptor antagonist; MDI, metered-dose inhaler; PEF, peak expiratory flow; SCS, systemic corticosteroids; URTI, upper respiratory tract infection.