Efficacy and Safety of Roflumilast in Asthma Management: A Systematic Review and Meta-Analysis

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Efficacy and Safety of Roflumilast in Asthma Management: A Systematic Review and Meta-Analysis

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https://doi.org/10.54963/entu.v15i4.1673
Alruwaili, M., Alamer, R. F., Ahmed, R., Alanzi, H., Alsabhan, R., Alhamzani, F., Alrashidi, H., Alanzi, R., Alshammari, E., Alshammari, N., Alrashidi, M., Al-Humian, H., Alsaeed, N., Aljohani, R. F., & Ahmed, R. (2025). Efficacy and Safety of Roflumilast in Asthma Management: A Systematic Review and Meta-Analysis. ENT Updates, 15(4), 20–34. https://doi.org/10.54963/entu.v15i4.1673
Volume 15 Issue 4 (2025)
Copyright (c) 2025 Musaad Alruwaili, Rakan Fahad Alamer, Raneem Ahmed, Hajar Alanzi, Rahaf Alsabhan, Faisal Alhamzani, Hanadi Alrashidi, Ryam Alanzi, Emtenan Alshammari, Nada Alshammari, Mnsorha Alrashidi, Hmoud Al-Humian, Noura Alsaeed, Rimas Fawaz Aljohani, Ruba Ahmed
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This work is licensed under a Creative Commons Attribution 4.0 International License.

Authors

  • Musaad Alruwaili

    Pharmaceutical Care Department, Turaif General Hospital, Northern Borders Health Cluster, Turaif 75311, Saudi Arabia
  • Rakan Fahad Alamer

    Pharmacist, King Salman Specialist Hospital, Hail 55471, Saudi Arabia
  • Raneem Ahmed

    Department of Pharmacy, College of Pharmacy, Jazan University, Jazan 45142, Saudi Arabia
  • Hajar Alanzi

    Department of Doctor of Pharmacy, College of Pharmacy, University of Hail, Hail 55476, Saudi Arabia
  • Rahaf Alsabhan

    Department of Doctor of Pharmacy, College of Pharmacy, University of Hail, Hail 55476, Saudi Arabia
  • Faisal Alhamzani

    Department of Doctor of Pharmacy, College of Pharmacy, University of Hail, Hail 55476, Saudi Arabia
  • Hanadi Alrashidi

    Department of Pharmacy, College of Pharmacy, University of Hail, Hail 55476, Saudi Arabia
  • Ryam Alanzi

    Department of Doctor of Pharmacy, College of Pharmacy, University of Hail, Hail 55476, Saudi Arabia
  • Emtenan Alshammari

    Department of Doctor of Pharmacy, College of Pharmacy, University of Hail, Hail 55476, Saudi Arabia
  • Nada Alshammari

    Department of Doctor of Pharmacy, College of Pharmacy, University of Hail, Hail 55476, Saudi Arabia
  • Mnsorha Alrashidi

    Department of Nursing, PHC Aljmeen, Hail Health Cluster, Hail 55471, Saudi Arabia
  • Hmoud Al-Humian

    Department of Doctor of Pharmacy, College of Pharmacy, University of Hail, Hail 55476, Saudi Arabia
  • Noura Alsaeed

    Department of Doctor of Pharmacy, College of Pharmacy, University of Hail, Hail 55476, Saudi Arabia
  • Rimas Fawaz Aljohani

    Department of Doctor of Pharmacy, College of Pharmacy, University of Hail, Hail 55476, Saudi Arabia
  • Ruba Ahmed

    Department of Pharmacy, College of Pharmacy, Jazan University, Jazan 45142, Saudi Arabia

Received: 30 September 2025; Revised: 8 December 2025; Accepted: 19 December 2025; Published: 29 December 2025

Asthma is a chronic respiratory condition affecting millions globally, causing significant morbidity and economic burden. Despite advances in treatment, many patients experience uncontrolled symptoms and exacerbations, particularly those with corticosteroid resistance or neutrophilic inflammation. Roflumilast, an oral phosphodiesterase-4 inhibitor, may offer additional benefits by targeting inflammatory pathways that are not fully controlled by standard therapy. This systematic review and meta-analysis aimed to assess the efficacy and safety of roflumilast in patients with asthma. A comprehensive literature search was conducted using the PubMed, Scopus, and Web of Science databases from January 2015 to August 2025. We included randomized controlled trials and pooled analyses evaluating roflumilast in patients with asthma. The primary outcome was the mean difference in the forced expiratory volume in one second between the intervention and control groups. Secondary outcomes included risk of exacerbation, symptom control, and adverse events. Six studies met the inclusion criteria, with 2845 participants. Roflumilast showed a modest improvement in forced expiratory volume in one second (Mean difference: +0.04 L; 95% confidence interval: −0.01 to +0.09; heterogeneity = 41%), which was not statistically significant. Exacerbation risk reduction was inconsistent across studies (Risk ratio: 0.96; 95% confidence interval: 0.83–1.12; heterogeneity = 35%). Adverse events, particularly gastrointestinal issues and weight loss, were more frequent with roflumilast, leading to higher rates of discontinuation. Subgroup analysis suggested potential benefits in patients with persistent airway inflammation or corticosteroid resistance, whereas harm was observed in obese patients. The limited number of trials and heterogeneity among studies restricted the conclusiveness of our findings.

Keywords:

Asthma Inflammation Corticosteroids Roflumilast Lung Function Exacerbations

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