Efficacy of Roflumilast in Bronchiectasis Patients with Frequent Exacerbations: A Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical Trial
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 bronchiecta...
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| Format: | Article |
| Language: | English |
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The Korean Academy of Tuberculosis and Respiratory Diseases
2022-01-01
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| Series: | Tuberculosis and Respiratory Diseases |
| Subjects: | |
| Online Access: | http://www.e-trd.org/upload/pdf/trd-2021-0051.pdf |
| _version_ | 1818939584043548672 |
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| author | Siwasak Juthong Pattaraporn Panyarath |
| author_facet | Siwasak Juthong Pattaraporn Panyarath |
| author_sort | Siwasak Juthong |
| collection | DOAJ |
| description | 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-blinded, randomized, placebo-controlled trial. Our primary objective was to assess the effect of roflumilast compared with that of a placebo in reducing exacerbation rates in bronchiectasis patients. The secondary objectives were the changes in forced expiratory volume in 1 second (FEV1) and St. George’s Respiratory Questionnaire (SGRQ). Bronchiectasis patients older than 18 years who had had two exacerbations during the previous 12 months were randomly assigned to receive either 500 μg of either roflumilast or a placebo once daily for 6 months in a 1:1 ratio. Results Forty bronchiectasis patients who had 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. Prebronchodilator FEV1 increased by 0.07 L from baseline in the roflumilast group and decreased by 0.015 L 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. Conclusion Roflumilast did not significantly affect the rate of exacerbations or quality of life. However, FEV1 tended to improve more in the roflumilast group than in the placebo group. |
| first_indexed | 2024-12-20T06:26:04Z |
| format | Article |
| id | doaj.art-8db4d5da7a9b4501861d21208a2ec7aa |
| institution | Directory Open Access Journal |
| issn | 1738-3536 2005-6184 |
| language | English |
| last_indexed | 2024-12-20T06:26:04Z |
| publishDate | 2022-01-01 |
| publisher | The Korean Academy of Tuberculosis and Respiratory Diseases |
| record_format | Article |
| series | Tuberculosis and Respiratory Diseases |
| spelling | doaj.art-8db4d5da7a9b4501861d21208a2ec7aa2022-12-21T19:50:17ZengThe Korean Academy of Tuberculosis and Respiratory DiseasesTuberculosis and Respiratory Diseases1738-35362005-61842022-01-01851677310.4046/trd.2021.00514588Efficacy of Roflumilast in Bronchiectasis Patients with Frequent Exacerbations: A Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical TrialSiwasak Juthong0Pattaraporn Panyarath1 Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, ThailandBackground 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-blinded, randomized, placebo-controlled trial. Our primary objective was to assess the effect of roflumilast compared with that of a placebo in reducing exacerbation rates in bronchiectasis patients. The secondary objectives were the changes in forced expiratory volume in 1 second (FEV1) and St. George’s Respiratory Questionnaire (SGRQ). Bronchiectasis patients older than 18 years who had had two exacerbations during the previous 12 months were randomly assigned to receive either 500 μg of either roflumilast or a placebo once daily for 6 months in a 1:1 ratio. Results Forty bronchiectasis patients who had 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. Prebronchodilator FEV1 increased by 0.07 L from baseline in the roflumilast group and decreased by 0.015 L 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. Conclusion Roflumilast did not significantly affect the rate of exacerbations or quality of life. However, FEV1 tended to improve more in the roflumilast group than in the placebo group.http://www.e-trd.org/upload/pdf/trd-2021-0051.pdfbronchiectasisexacerbationslung functionsroflumilast |
| spellingShingle | Siwasak Juthong Pattaraporn Panyarath Efficacy of Roflumilast in Bronchiectasis Patients with Frequent Exacerbations: A Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical Trial Tuberculosis and Respiratory Diseases bronchiectasis exacerbations lung functions roflumilast |
| title | Efficacy of Roflumilast in Bronchiectasis Patients with Frequent Exacerbations: A Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical Trial |
| title_full | Efficacy of Roflumilast in Bronchiectasis Patients with Frequent Exacerbations: A Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical Trial |
| title_fullStr | Efficacy of Roflumilast in Bronchiectasis Patients with Frequent Exacerbations: A Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical Trial |
| title_full_unstemmed | Efficacy of Roflumilast in Bronchiectasis Patients with Frequent Exacerbations: A Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical Trial |
| title_short | Efficacy of Roflumilast in Bronchiectasis Patients with Frequent Exacerbations: A Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical Trial |
| title_sort | efficacy of roflumilast in bronchiectasis patients with frequent exacerbations a double blinded randomized placebo controlled pilot clinical trial |
| topic | bronchiectasis exacerbations lung functions roflumilast |
| url | http://www.e-trd.org/upload/pdf/trd-2021-0051.pdf |
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