Abstract

Background: Bronchiectasis patients with neutrophilic airway inflammation develop symptoms of chronic cough,sputum production, and recurrent exacerbations. Roflumilast has anti-inflammatory actions via decreased neutrophilicairway inflammation. The effectiveness of roflumilast to reduce bronchiectasis exacerbation has never been evaluated. Methods: We conducted a double-blinded, randomized, placebo-controlled trial. Our primary objective was to assessthe effect of roflumilast compared with that of a placebo in reducing exacerbation rates in bronchiectasis patients. Thesecondary objectives were the changes in forced expiratory volume in 1 second (FEV1) and St. George’s RespiratoryQuestionnaire (SGRQ). Bronchiectasis patients older than 18 years who had had two exacerbations during the previous12 months were randomly assigned to receive either 500 μg of either roflumilast or a placebo once daily for 6 months in a1:1 ratio. Results: Forty bronchiectasis patients who had experienced exacerbations were screened. Thirty patients completedthe study after 6 months of treatment: roflumilast group (n=15) and placebo group (n=15). The rates of exacerbationswere 0.57 and 0.59 per patient in the roflumilast and placebo groups, respectively. Prebronchodilator FEV1 increased by0.07 L from baseline in the roflumilast group and decreased by 0.015 L in the placebo group, but the difference was notsignificant. No significant differences were observed in the change of SGRQ scores between the roflumilast and placebogroups. Roflumilast had significant side effects, including loss of appetite and headache. Conclusion: Roflumilast did not significantly affect the rate of exacerbations or quality of life. However, FEV1 tended toimprove more in the roflumilast group than in the placebo group.