Background and objectiveProcaterol, a selective, short-acting beta-2 adrenoceptor agonist, is effective in treating classical' asthma, but its efficacy for cough-variant asthma (CVA) is unknown. We evaluated the efficacy and safety of procaterol combined with budesonide for CVA. MethodsA prospective, randomized, double-blind, placebo-controlled, multicenter trial in China was conducted. One hundred and fifty-nine patients diagnosed with CVA (aged 18-75 years) were randomly divided into two groups to receive twice daily for 8 weeks, inhaled budesonide 100g plus either oral procaterol 25g or placebo. Primary and secondary efficacy variables were cough symptom severity scores and Leicester Cough Questionnaire (LCQ) life quality scores. Adverse events were also assessed. ResultsThe budesonide/placebo and budesonide/procaterol groups contained 80 and 78 participants (one excluded for later diagnosis of eosinophilic bronchitis), respectively, with similar baseline characteristics. Daily cough score declined during treatment in both groups and was lower in the budesonide/procaterol group at 8 (0.44 vs 0.73) and 10 (0.36 vs 0.69) weeks (P<0.05). Compared with the budesonide/placebo group, the proportion of patients with a reduction of 3 points or greater (66% vs 42%) and that of patients scoring 0 points (63% vs 51%) was higher in the budesonide/procaterol group for daily cough scores (P<0.05). At 8 weeks, LCQ score improvement was superior in the budesonide/procaterol group (38.9419.24 vs 32.7118.92; P<0.05). ConclusionProcaterol combined with budesonide was well tolerated and effective at improving cough symptoms and quality of life in patients with CVA. A randomized, double-blind, placebo-controlled, multicenter trial was undertaken to evaluate the efficacy and safety of procaterol combined with budesonide for treatment of patients with cough-variant asthma. Procaterol combined with budesonide was well tolerated and superior to budesonide alone at improving cough symptoms and patient quality of life.