Key inclusion and exclusion criteria

Inclusion criteriaExclusion criteria
  • Male and/or female patients aged ≥18 years

    Physician-diagnosed asthma for ≥6 months prior to visit 1

    Use of low- or medium-dose ICS/LABA# for ≥3 months prior to visit 1

    Worsening of asthma symptoms requiring overuse of reliever medication at least once within 30 days prior to visit 1

    Patient-reported history of one or more severe asthma exacerbations requiring treatment with systemic corticosteroids during the 12 months prior to visit 1, except in the previous 30 days

    Ability to perform FENO and spirometry assessments at home and complete an asthma symptom diary on a regular basis

  • Patients with any significant disease or disorder or evidence of drug/substance abuse that would pose a risk to patient safety, interfere with study conduct or impact study results

    Any asthma worsening requiring a change in treatment other than the prescribed reliever medication within 30 days prior to visit 1

    Medical history of life-threatening asthma, including intubation and admission to an intensive care unit

    Medical conditions (except allergic rhinitis) or medications (except ICS) that may influence FENO

    Concurrent respiratory disease (e.g. cystic fibrosis, idiopathic pulmonary fibrosis or pulmonary arterial hypertension)

    Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to visit 1 or during screening/run-in period

    A severe exacerbation (resulting in ≥3 days of oral corticosteroids (or one depot intramuscular injection of glucocorticosteroid), an urgent care or emergency room visit resulting in treatment with systemic corticosteroids or an inpatient hospitalisation due to asthma) within 30 days prior to screening

    Any disease, other than asthma, or procedure that may necessitate the use of oral/systemic corticosteroids during the treatment period

    Current tobacco smoking or a history of smoking for ≥10 pack-years

ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; FENO: exhaled nitric oxide fraction. #: low ICS doses (daily): beclometasone dipropionate hydrofluoroalkane (HFA) (100–200 µg), budesonide dry-powder inhaler (DPI) (200–400 µg), ciclesonide HFA (80–160 µg), fluticasone furoate DPI (100 µg), fluticasone propionate DPI or HFA (100–250 µg), mometasone furoate (110–220 µg) and triamcinolone acetonide (400–1000 µg); medium ICS doses (daily): beclometasone dipropionate HFA (>200–400 µg), budesonide DPI (>400–800 µg), ciclesonide HFA (>160–320 µg), fluticasone propionate DPI or HFA (>250–500 µg), mometasone furoate (>220–440 µg) and triamcinolone acetonide (>1000–2000 µg). : overuse was defined as more than the standard use of reliever for individual patients.