Table 2

Study inclusion and exclusion criteria

Inclusion criteriaParticipants must satisfy ALL of the following criteria at study entry:
▸ Participants who the investigator believes can and will comply with the requirements of the protocol
▸ Written informed consent obtained from the participant
▸ Male or female aged 40–85 years
▸ Confirmed diagnosis of COPD based on postbronchodilator spirometry27 with FEV1 ≤80% of predicted normal and FEV1/FVC <0.7
▸ Moderate, severe or very severe COPD, according to GOLD staging27
▸ History of ≥10 pack-years of cigarette smoking*,†
▸ Documented history of ≥1 exacerbation requiring antibiotics and/or oral corticosteroids or hospitalisation in the previous 12 months‡
Exclusion criteria▸ A confirmed diagnosis of asthma (as only cause of obstructive respiratory disorder), cystic fibrosis, pneumonia risk factors or other respiratory disorders (eg, tuberculosis, lung cancer, etc)
▸ History of lung surgery
▸ α-1 antitrypsin deficiency as underlying cause of COPD
▸ Moderate or severe COPD exacerbation not resolved at least 1 month prior to enrolment and less than 30 days following the last dose of oral corticosteroids§
▸ Long-term corticosteroid or antibiotic therapy
▸ Use of any antibacterial, antiviral or respiratory investigational drug or vaccine within 30 days of the enrolment visit
▸ Evidence of alcohol or drug abuse
▸ Presence of other conditions that the principal investigator judges may interfere with the study findings
▸ Risk of non-compliance or inability to comply with the study procedures
▸ Women who are pregnant or lactating or are planning on becoming pregnant during the study

  • *Former smokers are defined as those who have stopped smoking for at least 6 months.

  • †Number of pack years=(number of cigarettes per day/20)×number of years smoked.

  • ‡Participants with recent COPD exacerbations, in stable condition, and having stopped antibiotics, can be enrolled 1 month postexacerbation.

  • §Participants can be enrolled when their AECOPD or pneumonia has resolved.

  • AECOPD, acute exacerbations of chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; GOLD, Global Initiative for Chronic Obstructive Lung Disease.