Key inclusion and exclusion criteria

Key inclusion criteriaKey exclusion criteria
Age ≥18 years with a diagnosis of asthma based on GINA 2021 [28]
Existing treatment with medium- to high-dose ICS (≥250 μg fluticasone propionate twice daily or equipotent ICS daily dosage to a maximum of 2000 μg·day−1 of fluticasone propionate or equivalent) in combination with a second controller with a stable dose ≥1 month prior to visit 1 (screening visit)
Patients requiring a third controller for their asthma will be considered eligible and should be on a stable dose of the third controller for ≥1 month prior to visit 1
Pre-BD FEV1 ≤80% predicted at visit 1 and visit 2 (day 1 of the intervention period)
Uncontrolled moderate-to-severe asthma (ACQ-5 ≥1.5) at visit 1 and visit 2
Exhibit BD reversibility (≥12% and 200 mL improvement in FEV1 post-SABA administration) during screening
FeNO ≥35 ppb at visit 2 before randomisation (up to 550 patients can be enrolled with FeNO <35 ppb at visit 2)
History of ≥1 exacerbation(s) in the previous year
Capable of giving signed informed consent
History or clinical evidence of COPD including ACOS or any other significant lung disease
Current smoker (cigarette or e-cigarette) or cessation of smoking within 6 months before visit 1
Previous smoker with a smoking history >10 pack-years
Severe asthma exacerbation requiring treatment with SCS in the past month before visit 1 or during the screening period
Treatment with a live (attenuated) vaccine within 4 weeks before visit 1
Any biologic therapy or any other biologic therapy/immunosuppressant/immunomodulators within 4 weeks before visit 1 or five half-lives, whichever is longer
Current participation in any clinical trial of an investigational drug or device or participation within 3 months before the screening visit or five half-lives of the investigational compound, whichever is longer
Treatment with OCS for >2 weeks before visit 1

GINA: Global Initiative for Asthma; ICS: inhaled corticosteroids; BD: bronchodilator; FEV1: forced expiratory volume in 1 s; ACQ-5: five-item Asthma Control Questionnaire; SABA: short-acting β-agonist; FeNO: fractional exhaled nitric oxide; ACOS: asthma–COPD overlap syndrome; SCS: systemic corticosteroids; OCS: oral corticosteroids.