Trial design and data analysis
alpha1-antitrypsin deficiency, bronchiectasis, asthma
ALPHA1-ANTITRYPSIN DEFICIENCY, BRONCHIECTASIS, HYPOGAMMAGLOBULINEMIA, PERIODONTITIS, CYSTIC FIBROSIS, COMMON VARIABLE IMMUNODEFICIENCY, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, SECONDARY, ASTHMA
The WILLOW trial (ClinicalTrials.gov: NCT03218917; EudraCT: 2017-002533-32) was a randomized, double-blind, placebo-controlled, parallel-group trial conducted at 116 sites across 14 countries [Key exclusion criteria included bronchiectasis due to a clinical diagnosis of cystic fibrosis, hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency, as well as an investigator-determined primary diagnosis of chronic obstructive pulmonary disease or asthma (secondary diagnoses were allowed). Because of potential dental side effects of treatment with brensocatib, exclusion criteria were structured to avoid the enrollment of patients with severe periodontitis.The WILLOW Statistical Analysis Plan (SAP) is discussed in the Additional file 