Comparative Effectiveness of Roflumilast and Azithromycin in Reducing Exacerbations in Severe Chronic Obstructive Pulmonary Disease ( COPD ) Patients With Chronic Bronchitis Phenotype

Summary

"The study is a randomized controlled trial comparing roflumilast and azithromycin as add-on therapies in 70 patients with severe chronic obstructive pulmonary disease (COPD ) and frequent exacerbations. Participants will receive one of the two treatments for six months while continuing standard inhaled therapy. The study aims to determine which drug is more effective in reducing exacerbations and improving clinical outcomes such as forced expiratory volume in one second( FEV1) and modified medical research council ( mMRC)dyspnea scale , hospitalization, adherence, and safety, thereby providing evidence to guide chronic obstructive pulmonary disease management in our local population."

Timeline

Start

2027-02

Primary completion

2027-02

Completion

2027-02

Publications

• Background Candela M, Costorella R, Stassaldi A, Maestrini V, Curradi G. Treatment of COPD: the simplicity is a resolved complexity. Multidiscip Respir Med. 2019 Jun 3;14:18. doi: 10.1186/s40248-019-0181-8. eCollection 2019. No abstract available.
• Background Asim, Z., Sadaf, A. and Shah, S.K.H., 2025. Breathing Easier? The True Efficacy of Roflumilast in COPD Compared to Placebo. Health Aff., 13(4): 2539-2564.
• Background Al-Jahdali H, Al-Lehebi R, Lababidi H, Alhejaili FF, Habis Y, Alsowayan WA, Idrees MM, Zeitouni MO, Alshimemeri A, Al Ghobain M, Alaraj A, Alhamad EH. The Saudi Thoracic Society Evidence-based guidelines for the diagnosis and management of chronic obstructive pulmonary disease. Ann Thorac Med. 2025 Jan-Mar;20(1):1-35. doi: 10.4103/atm.atm_155_24. Epub 2024 Sep 24.
• Background Ahmadian S, Sin DD, Lynd L, Harrison M, Sadatsafavi M. Benefit-harm analysis of azithromycin for the prevention of acute exacerbations of chronic obstructive pulmonary disease. Thorax. 2022 Nov;77(11):1079-1087. doi: 10.1136/thoraxjnl-2021-217962. Epub 2021 Nov 26.

Drugs

Indications