Tranexamic acid (TA) is an antifibrinolytic drug currently used systemically to control bleeding. To date, there have been no prospective studies of the effectiveness of inhaled TA for the treatment of hemoptysis. The goal of this study was to prospectively assess the effectiveness of TA inhalations (ie, nebulized TA) for hemoptysis treatment. This analysis was a double-blind, randomized controlled trial of treatment with nebulized TA (500mg tid) vsplacebo (normal saline) in patients admitted with hemoptysis of various etiologies. Patients with massive hemoptysis (expectorated blood > 200mL/24 h) and hemodynamic or respiratory instability were excluded. Mortality and hemoptysis recurrence rate were assessed at 30days and following 1 year. Forty-seven patients were randomized to receive TA inhalations (n= 25) or normal saline (n= 22). TA was associated with a significantly reduced expectorated blood volume starting from day 2 of admission. Resolution of hemoptysis within 5days of admission was observed in more TA-treated patients than in those receiving placebo (96%vs50%; P< .0005). Mean hospital length of stay was shorter for the TA group (5.7 ± 2.5days vs7.8 ± 4.6days; P= .046), with fewer patients requiring invasive procedures such as interventional bronchoscopy or angiographic embolization to control the bleeding (0%vs18.2%; P= .041). No side effects were noted in either group throughout the follow-up period. In addition, a reduced recurrence rate was noted at the 1-year follow-up (P= .009). TA inhalations can be used safely and effectively to control bleeding in patients with nonmassive hemoptysis. ClinicalTrials.gov; No.: NCT01496196; URL: www.clinicaltrials.gov.