Predictors of exacerbation risk and response to budesonide in patients with chronic obstructive pulmonary disease: a post-hoc analysis of three randomised trials

摘要: Summary Background The peripheral blood eosinophil count might help identify those patients with chronic obstructive pulmonary disease (COPD) who will experience fewer exacerbations when taking inhaled corticosteroids (ICS). Previous post-hoc analyses have proposed cutoffs that are both arbitrary and limited in evaluating complex interactions of treatment response. We modelled as a continuous variable to determine the characteristics exacerbation risk clinical response ICS COPD. Methods analysed data from three AstraZeneca randomised controlled trials budesonide–formoterol COPD history available counts. Patients any asthma were excluded. Negative binomial regression analysis was done using splines for modelling variables study primary outcome annual rate adjusted exposure time design. registered ClinicalTrials.gov, NCT00206167, NCT00206154, NCT00419744. Findings 4528 studied. A non-linear increase occurred increasing received formoterol alone. At counts 0·10 × 10 9 cells per L or more, significant effect recorded reduction compared alone (rate ratio 0·75, 95% CI 0·57–0·99; p interaction =0·015). Interactions observed between effects over on St George's Respiratory Questionnaire (p =0·0043) pre-bronchodilator FEV 1 (linear =0·067). Only smoking independent predictors reducing (eosinophil count, =0·013; history, Interpretation In treated formoterol, predicts ICS. Funding AstraZeneca.