Formoterol Plus Inhaled Corticosteroid Fixed-Dose Combinations for Symptom Relief in Chronic Asthma Management: A Systematic Review and Meta-Analysis
1
Health Systems Research Unit, South African Medical Research Council, Cape Town, South Africa
2
Discipline of General Surgery, Nelson R Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa
3
Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa
4
Discipline of Paediatrics and Child Health, Nelson R Mandela School of Medicine, College of Health Sciences, University of KwaZulu-Natal, Durban, South Africa
5
Department of Paediatrics, University of Cape Town, Cape Town, South Africa
6
Division of Infectious Diseases, Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
7
Infectious Diseases and Oncology Research Institute, University of the Witwatersrand, Johannesburg, South Africa
8
Division of Pulmonology, Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa
9
Amajuba District Clinical Specialist Team, KwaZulu-Natal Department of Health, KwaZulu-Natal, South Africa
10
Centre for Evidence-based Health Care, Division of Epidemiology and Biostatistics, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa
11
Clinton Health Access Initiative, Pretoria, South Africa
12
Affordable Medicines Directorate, National Department of Health, Pretoria, South Africa
Popul. Med. 2026;8(Supplement Supplement 1):A3018
ABSTRACT
BACKGROUND:
Asthma is an important non-communicable disease globally, causing morbidity in people of all ages. Using fixed-dose combinations (FDCs) of inhaled corticosteroids (ICS) and fast-onset, long-acting beta2-agonists (LABAs), such as formoterol, for both symptom relief and maintenance, may improve asthma control. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of FDC ICS plus formoterol for maintenance and reliever therapy, compared with ICS/LABA FDC maintenance therapy and as-needed short-acting beta2-agonist (SABA) for symptom relief, in patients aged 12 years and older with moderate to severe asthma.
METHODS:
We systematically searched PubMed and the Cochrane Central Register of Controlled Trials for randomised controlled trials. We screened records in duplicate, with independent data extraction and appraisal. We conducted a random-effects meta-analysis in RevMan. We reported risk ratios (RRs) and 95% confidence intervals (CIs) for dichotomous outcomes. We used the GRADE approach to assess the certainty of evidence for each outcome. PROSPERO registration: CRD42023485640.
RESULTS:
We screened 680 records and assessed 23 full-text articles for eligibility; 11 eligible trials, with 20,496 participants, were included. ICS/formoterol maintenance and reliever, when compared to ICS/LABA maintenance and a SABA reliever, reduced severe asthma exacerbations (Risk Ratio [RR] 0.71; 95% Confidence Interval [CI] 0.65 to 0.77; high-certainty evidence), corresponding to 43 fewer cases per 1,000 patients (ranging from 52 fewer to 34 fewer). There was little to no difference in overall adverse events or all-cause mortality between groups.
CONCLUSIONS:
In adults and adolescents with moderate-to-severe asthma, ICS/formoterol maintenance and reliever therapy, compared to ICS/LABA maintenance and SABA reliever, prevents one severe asthma exacerbation for every 24 people treated, with little to no difference in harms. Use of ICS/formoterol FDC for maintenance and relief minimises inappropriate use of bronchodilator therapy without concomitant corticosteroid, simplifies treatment and may promote adherence.
Asthma is an important non-communicable disease globally, causing morbidity in people of all ages. Using fixed-dose combinations (FDCs) of inhaled corticosteroids (ICS) and fast-onset, long-acting beta2-agonists (LABAs), such as formoterol, for both symptom relief and maintenance, may improve asthma control. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of FDC ICS plus formoterol for maintenance and reliever therapy, compared with ICS/LABA FDC maintenance therapy and as-needed short-acting beta2-agonist (SABA) for symptom relief, in patients aged 12 years and older with moderate to severe asthma.
METHODS:
We systematically searched PubMed and the Cochrane Central Register of Controlled Trials for randomised controlled trials. We screened records in duplicate, with independent data extraction and appraisal. We conducted a random-effects meta-analysis in RevMan. We reported risk ratios (RRs) and 95% confidence intervals (CIs) for dichotomous outcomes. We used the GRADE approach to assess the certainty of evidence for each outcome. PROSPERO registration: CRD42023485640.
RESULTS:
We screened 680 records and assessed 23 full-text articles for eligibility; 11 eligible trials, with 20,496 participants, were included. ICS/formoterol maintenance and reliever, when compared to ICS/LABA maintenance and a SABA reliever, reduced severe asthma exacerbations (Risk Ratio [RR] 0.71; 95% Confidence Interval [CI] 0.65 to 0.77; high-certainty evidence), corresponding to 43 fewer cases per 1,000 patients (ranging from 52 fewer to 34 fewer). There was little to no difference in overall adverse events or all-cause mortality between groups.
CONCLUSIONS:
In adults and adolescents with moderate-to-severe asthma, ICS/formoterol maintenance and reliever therapy, compared to ICS/LABA maintenance and SABA reliever, prevents one severe asthma exacerbation for every 24 people treated, with little to no difference in harms. Use of ICS/formoterol FDC for maintenance and relief minimises inappropriate use of bronchodilator therapy without concomitant corticosteroid, simplifies treatment and may promote adherence.
| eISSN: | 2654-1459 |
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