Table 2.
Study inclusion and exclusion criteria
Inclusion criteria |
Participants 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.