The Journal of asthma : official journal of the Association for the Care of Asthma · 2026
Safety and Efficacy of Albuterol-Budesonide Versus Albuterol Alone in Asthma: A GRADE-assessed Systematic Review and Meta-Analysis of Randomized Controlled Trials.
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Ul Abideen Zain, Ashraf Muhammad Farhan, Javed Sara, Khalid Laiba, Malik Muhammad Owais, Bhagwan das Neha, Ambreen Abida, Faheem Taqwa, Jalal Amna Amir, Ahmad Arsalan
Аннотация
OBJECTIVE: This systematic review and meta-analysis evaluated the efficacy and safety of the recently FDA-approved fixed-dose combination of albuterol (a short-acting β2-agonist) and budesonide (an inhaled corticosteroid) as a reliever therapy in patients with asthma.
DATA SOURCES: A comprehensive literature search was conducted in PubMed, Cochrane Central Register of Controlled Trials, and Google Scholar from inception to the latest available date.
STUDY SELECTIONS: Randomized controlled trials (RCTs) enrolling patients aged ≥12 years with asthma and comparing albuterol-budesonide with albuterol alone or standard reliever therapy were included. Outcomes assessed were risk, number, and annual rate of severe exacerbations; lung function changes (forced expiratory volume in 1 second [FEV1] at week 12); systemic corticosteroid exposure; and adverse events. Hazard ratios (HRs) were used for time-to-event data, relative risks (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes. Certainty of evidence was evaluated using the GRADE approach.
RESULTS: Three RCTs comprising 6,134 participants met the inclusion criteria. Albuterol-budesonide significantly reduced the risk (HR = 0.72; 95% CI: 0.58-0.89; p = 0.002), number (RR = 0.64; 95% CI: 0.49-0.82; p = 0.0006), and annual rate (RR = 0.68; 95% CI: 0.51-0.89; p = 0.006) of severe exacerbations. Significant improvements in FEV1 were observed (MD = 80.19 mL; 95% CI: 46.46-113.92; p < 0.0001), alongside reduced annual systemic corticosteroid exposure (MD = -39.33 mg; 95% CI: -62.77 to -15.89; p = 0.001). Adverse events were comparable between groups (RR = 0.99; 95% CI: 0.94-1.04; p = 0.61). The certainty of evidence was moderate for the risk and annual rate of severe exacerbations and for corticosteroid exposure, low for the number of severe exacerbations and for FEV1, and high for adverse events.
CONCLUSION: Albuterol-budesonide significantly reduces severe asthma exacerbations and systemic corticosteroid use while improving lung function, supporting its use as an effective and safe reliever therapy in asthma management, although the small number of trials and the heterogeneity seen for some outcomes should be kept in mind.
DATA SOURCES: A comprehensive literature search was conducted in PubMed, Cochrane Central Register of Controlled Trials, and Google Scholar from inception to the latest available date.
STUDY SELECTIONS: Randomized controlled trials (RCTs) enrolling patients aged ≥12 years with asthma and comparing albuterol-budesonide with albuterol alone or standard reliever therapy were included. Outcomes assessed were risk, number, and annual rate of severe exacerbations; lung function changes (forced expiratory volume in 1 second [FEV1] at week 12); systemic corticosteroid exposure; and adverse events. Hazard ratios (HRs) were used for time-to-event data, relative risks (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes. Certainty of evidence was evaluated using the GRADE approach.
RESULTS: Three RCTs comprising 6,134 participants met the inclusion criteria. Albuterol-budesonide significantly reduced the risk (HR = 0.72; 95% CI: 0.58-0.89; p = 0.002), number (RR = 0.64; 95% CI: 0.49-0.82; p = 0.0006), and annual rate (RR = 0.68; 95% CI: 0.51-0.89; p = 0.006) of severe exacerbations. Significant improvements in FEV1 were observed (MD = 80.19 mL; 95% CI: 46.46-113.92; p < 0.0001), alongside reduced annual systemic corticosteroid exposure (MD = -39.33 mg; 95% CI: -62.77 to -15.89; p = 0.001). Adverse events were comparable between groups (RR = 0.99; 95% CI: 0.94-1.04; p = 0.61). The certainty of evidence was moderate for the risk and annual rate of severe exacerbations and for corticosteroid exposure, low for the number of severe exacerbations and for FEV1, and high for adverse events.
CONCLUSION: Albuterol-budesonide significantly reduces severe asthma exacerbations and systemic corticosteroid use while improving lung function, supporting its use as an effective and safe reliever therapy in asthma management, although the small number of trials and the heterogeneity seen for some outcomes should be kept in mind.