TABLE 2

Key inclusion and exclusion criteria of the INTREPID study

Inclusion criteria
 Informed consent: capable of giving signed, informed consent
 Age and sex: male and female aged ≥40 years
 COPD diagnosis: documented physician diagnosis of COPD
 Severity of COPD symptoms: a score of ≥10 on CAT at screening
 History of exacerbations: a history of treatment with systemic/oral corticosteroids, antibiotics and/or hospitalisation for ≥1 COPD exacerbation in the 3 years prior to randomisation#
 Existing COPD maintenance treatment: currently receiving one of the below non-ELLIPTA maintenance therapies and have been prescribed it continually for ≥16 weeks prior to randomisation:
  ICS in combination with LAMA and LABA (MITT)
  LAMA and LABA combination therapy
  ICS and LABA combination therapy
Exclusion criteria
 Unstable COPD: resolution of an exacerbation within 2 weeks of visit 1+
 Prior/concomitant therapy with oral corticosteroid: chronic use of oral corticosteroid for respiratory or other indications in the opinion of the investigator§
 Women of child-bearing potential: women who are pregnant, lactating or planning to become pregnant during the study period
 Medical conditions: any illness judged in the opinion of the investigator to cause a low probability of 6-month survival
 Other diseases/abnormalities: historical or current evidence of uncontrolled or clinically significant diseaseƒ
 Hypersensitivity: history of hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, β2-agonist, lactose/milk protein or magnesium stearate, or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator, contraindicates study participation
 Participation in interventional clinical studies: taking part in any investigational drug treatment within 30 days or five half-lives of the prior investigational drug before visit 1

CAT: COPD assessment test; LAMA: long-acting muscarinic antagonist; LABA: long-acting β2-agonist; MITT: multiple-inhaler triple therapy; ICS: inhaled corticosteroid. #: captured through patient recall and/or medical records and must be documented in patient notes. Prior use of systemic/oral corticosteroids and/or antibiotics alone does not qualify as exacerbation history unless treatment was associated with the worsening of COPD symptoms. : patients on dual maintenance therapy on enrolment must be considered by their physician to require a step-up to triple therapy and the reason for the physician decision must be documented. +: patients may be rescreened 2 weeks after resolution of an exacerbation. §: chronic use is defined as more than 14 days' continuous use during the 12 weeks prior to visit 1; ƒ: significant disease is defined as any disease that, in the opinion of the investigator, would put the safety of the patient at risk by participating, or would impact the effectiveness or safety analysis if the disease/condition exacerbated during the study.