Replication of the D58 Asthma Trial in Healthcare Claims Data

Inclusion Criteria:

• ≥12 years of age
• Documented clinical diagnosis of asthma for ≥1 year prior to randomization
• History of at least one asthma exacerbation in the previous year (but none in the 4 weeks prior to randomization. An asthma exacerbation was defined as an event requiring treatment with systemic corticosteroids or requiring hospitalization (i.e. an inpatient stay or >24-hour stay in the observation area of an emergency room or local equivalent)

• Receiving either:

  1. A stable dose of ICS alone or in combination with a LABA, leukotriene receptor antagonist or other maintenance therapy/therapies for ≥4 weeks prior to randomization (any patient maintained on a stable high-dose ICS with or without a LABA or LTRA or other maintenance therapy/therapies was required to have an ACQ6 total score of \<1.5 at screening) OR
  2. A stable dose of LTRA or xanthine monotherapy (for ≥4 weeks prior to randomization) or daily SABA (in the 4 weeks before randomization but ≤8 puffs a day on two consecutive days, or ≥25 puffs in one day, in the 7 days prior to screening). Patients on LTRAs, xanthines, or daily SABA, were eligible only if they recorded an ACQ6 total score of ≥1.5, and in the investigator's clinical judgment, the patient's asthma severity could have justified treatment with ICS or ICS/LABA combination

Exclusion Criteria:

• A history of life-threatening asthma (defined as an asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilatory support)

• One of the following:

  1. Any asthma exacerbation requiring systemic corticosteroids within 4 weeks prior to randomization OR
  2. >4 separate exacerbations OR
  3. >2 hospitalizations (an inpatient stay or >24- hour stay in the observation area of an emergency room or local equivalent) due to asthma in the previous year
• Received systemic corticosteroids for any reason in the 4 weeks prior to randomization
• Had an ongoing asthma exacerbation requiring systemic corticosteroids
• Concurrent respiratory disease (chronic obstructive pulmonary disease, chronic bronchitis, emphysema, idiopathic pulmonary fibrosis, bronchiectasis, and/or any pulmonary disease)
• A smoking history of >10 pack-years
• Respiratory infection or other viral/bacterial illness
• Pregnancy (current/planned) and lactation
• Malignancy (with the exception of basal cell carcinoma) within the 5 years prior to study commencement
• Omalizumab or any other monoclonal/polyclonal antibody use in the 6 months prior to randomization
• Concomitant β-blocker use
• Drug/alcohol abuse