METHODS: FB recordings for six visualised features: secretions (amount and color) and mucosal appearance (erythema, pallor, ridging, oedema) based on pre-determined criteria on a pictorial chart were assessed by two physicians independently, blinded to the clinical history. These features were used to obtain various models of BScoreexp that were plotted against bronchoalveolar lavage (BAL) neutrophil % using a receiver operating characteristic (ROC) curve. Inter- and intra-rater agreement (weighted-kappa, K) were assessed from 30 FBs.

RESULTS: Using BAL neutrophilia of 20% to define inflammation, the highest area under ROC (aROC) of 0.71, 95%CI 0.61-0.82 was obtained by the giving three times weightage to secretion amount and color and adding it to erythema and oedema. Inter-rater K values for secretion amount (K = 0.87, 95%CI 0.73-1.0) and color (K = 0.86, 95%CI 0.69-1.0) were excellent. Respective intra-rater K were 0.95 (0.87-1.0) and 0.68 (0.47-0.89). Other inter-rater K ranged from 0.4 (erythema) to 0.64 (pallor).

METHODS AND ANALYSIS: We are undertaking an international multicentre, double-blind, placebo-RCT to evaluate whether 12 months of erdosteine is beneficial for children and adults with bronchiectasis. We will recruit 194 children and adults with bronchiectasis to a parallel, superiority RCT at eight sites across Australia, Malaysia and Philippines. Our primary endpoint is the rate of exacerbations over 12 months. Our main secondary outcomes are QoL, exacerbation duration, time-to-next exacerbation, hospitalisations and lung function.

ETHICS AND DISSEMINATION: The Human Research Ethics Committees (HREC) of Children's Health Queensland (for all Australian sites), University of Malaya Medical Centre (Malaysia) and St. Luke's Medical Centre (Philippines) approved the study. We will publish the results and share the outcomes with the academic and medical community, funding and relevant patient organisations.