Tuberc Respir Dis > Accepted Articles
DOI: https://doi.org/10.4046/trd.2021.0051    [Accepted]
Published online August 3, 2021.
Efficacy of Roflumilast in Bronchiectasis Patients with Frequent Exacerbations: A Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical Trial
Siwasak Juthong, M.D., Pattaraporn Panyarath, M.D.
Department of Internal Medicine, Faculty of Internal Medicine, Prince of Songkla University, Hat Yai, Songkhla 90110, Thailand
Correspondence:  Siwasak Juthong,
Email: jsiwasak@medicine.psu.ac.th
Pattaraporn Panyarath, Tel: +6674-451-474, Fax: +6674-455-855, 
Email: zealot_zine@hotmail.com
Received: 23 March 2021   • Revised: 24 May 2021   • Accepted: 1 August 2021
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 neutrophilic airway inflammation. The effectiveness of roflumilast to reduce bronchiectasis exacerbation has never been evaluated.
Methods
We conducted a double-blind, randomized, placebo-controlled trial. The primary objective was to assess the effect of roflumilast compared with placebo to reduce exacerbation rates in bronchiectasis patients. The secondary objectives were the changes in FEV1 and SGRQ. Bronchiectasis patients older than 18 years and had two exacerbations during the previous 12 months were randomly assigned to receive either 500 g of roflumilast or placebo once daily for 6 months in a 1:1 ratio.
Results
Forty bronchiectasis patients who experienced exacerbations were screened. Thirty patients completed the study after 6 months of treatment: roflumilast group (n=15) and placebo group (n=15). The rates of exacerbations were 0.57 and 0.59 per patient in the roflumilast and placebo groups, respectively. Pre-bronchodilator FEV1 increased by 0.07 liter from baseline in the roflumilast group and decreased by 0.015 liter in the placebo group but the difference was not significant. No significant differences were observed in the change of SGRQ scores between the roflumilast and placebo groups. Roflumilast had significant side effects including loss of appetite and headache.
Conclusions
Roflumilast did not significantly affect the rate of exacerbations and quality of life. However, FEV1 tended to improve in the roflumilast group compared with the placebo group.
Key Words: Bronchiectasis, Exacerbations, Lung functions, Roflumilast
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