TABLE 2.
Inclusion criteria | Exclusion criteria |
Male or female, aged ≥18 years# and ≤85 years at screening | AST and/or ALT >3× ULN at Visit 1 |
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice and local legislation | Estimated glomerular filtration rate according to CKD-EPI formula <30 mL·min−1 at Visit 1 |
Women of childbearing potential¶ adhering to contraception requirements | Absolute blood neutrophil count <1000/mm3 at Visit 1 |
Clinical history consistent with bronchiectasis (cough, chronic sputum production and/or recurrent respiratory infections) and investigator-confirmed diagnosis of bronchiectasis by CT scan | Acute SARS-CoV-2 infection |
History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either: 1) at least two exacerbations, or 2) one exacerbation and an SGRQ symptoms score of >40 at Screening Visit 1 | Current smokers, or stopped smoking only within 3 months of screening, or not willing to maintain non-smoking status for the duration of the study |
Current sputum producers with a history of chronic expectoration who are able to provide a spontaneous sputum sample at Screening Visit 1 | Current diagnosis of cystic fibrosis, hypogammaglobulinaemia, common variable immunodeficiency, α1-antitrypsin deficiency, or allergic bronchopulmonary aspergillosis requiring treatment |
Any acute infections (including respiratory infections) | |
Any mycobacterial infections, including pulmonary non-tuberculous mycobacterial disease, currently being treated | |
Severe periodontal disease (to be evaluated by a periodontist or dentist) or palmar keratosis | |
Any recent change in dose or regimen of maintenance bronchiectasis treatment | |
Any medical condition that could interfere with participation or conduct of the study |
AST: aspartate aminotransferase; ALT: alanine aminotransferase; ULN: upper limit of normal; CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration; CT: computed tomography; SARS-CoV-2: severe acute respiratory syndrome coronavirus 2; SGRQ: St George's Respiratory Questionnaire. #: ≥ 19 years in Republic of Korea; ¶: if allowed according to regulatory requirements.