Roflumilast (Daliresp®) to reduce acute pulmonary events in fibrotic sarcoidosis: a multi-center, double blind, placebo controlled, randomized clinical trial.

BACKGROUND

Fibrotic sarcoidosis patients often have acute events of increased cough and sputum production. We evaluated the impact of roflumilast in fibrotic sarcoidosis patients with repeated episodes of increased cough and sputum.

METHODS

Sarcoidosis patients with pulmonary fibrosis and at least two acute episodes in the previous year were randomized to receive either roflumilast (ROF) or placebo (PLA) in a double blind, placebo controlled multi-center trial. Subjects were assessed initially and every three months for 12 months. At each visit, spirometry and health related quality of life questionnaires were completed. For each subject, the best forced expiratory volume at 1 second (FEV-1) was noted.

RESULTS

Of the 38 subjects who enrolled in the study, 28 subjects (14 in each group) received at least three months of treatment and 10 in each arm completing all 12 months of study. During the treatment, patients treated with ROF were less likely to have visits in which the FEV-1 was less than 90% of the best FEV-1 (Odds ratio=0.34 (0.16 to 0.76 95% confidence interval, p=0.0073). At the end of treatment with ROF, patients had a significant improvement in their KSQ LUNG (Initial visit: 45.3 ± 6.89 (Mean ± S.D.); Last visit: 52.6± 7.91, p<0.05) with no change for PLA treated patients.

CONCLUSION

Patients treated with at least three months of roflumilast had fewer follow-up visits with an FEV-1 of less than 90% of best value. At the end of treatment, ROF treated patients had a better quality of life as assessed by KSQ LUNG.

CLINICAL TRIAL REGISTRATION

NCT01830959.

Informations de copyright

Copyright: © 2021 SARCOIDOSIS VASCULITIS AND DIFFUSE LUNG DISEASES.

Déclaration de conflit d'intérêts

RPB had full access to all the data in the study and takes responsibility for the content of the manuscript, including the data and analysis. RPB, EEL, MAJ, and DAC contributed substantially to study design. RPB, MAJ, DAC, JP, JZ, and EEL contributed substantially to data acquisition. RPB, SB, EEL, MAJ, and DAL contributed substantially to data analysis, interpretation, and writing of the manuscript Financial/nonfinancial disclosures: Astra Zeneca and NIH provided grant support for this study Astra Zeneca provided an unrestricted grant and provided drug. They had no role in study design, data analysis, interpretation, or writing of the manuscript.