Abstract
Recent clinical trials of as-needed fixed-dose combination of ICS/formoterol have provided new evidence that may warrant a reconsideration of current practice.
A task force (TF) was set up by the European Respiratory Society to provide evidence-based recommendations on the use of as-needed ICS/formoterol as treatment for mild asthma. The TF defined two questions that were assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach. The TF utilised the outcomes to develop recommendations for a pragmatic guideline for everyday clinical practice.
The TF suggests that adults with mild asthma use as-needed ICS/formoterol instead of regular ICS maintenance treatment plus as-needed short-acting beta-2-antagonists (SABAs), and that adolescents with mild asthma use either as-needed ICS/formoterol or ICS maintenance treatment plus as-needed SABA (Conditional Recommendation; Low Certainty of Evidence). The recommendation for adults places a relatively higher value on the reduction of systemic corticosteroid use and the outcomes related to exacerbations and a relatively lower value on the small differences in asthma control. Either treatment options are suggested for adolescent patients as the balance is very close and data more limited.
The TF recommends that adult and adolescent patients with mild asthma use as-needed ICS/formoterol instead of as-needed SABA (Strong Recommendation; Low Certainty of Evidence). This recommendation is based on the benefit of as-needed ICS/formoterol in mild asthma on several outcomes and the risks related to as-needed SABA in the absence of anti-inflammatory treatment.
The implementation of this recommendation is hampered in countries (including European Union countries) where as-needed ICS/formoterol is not approved for mild asthma.
Footnotes
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Conflict of interest: Alberto Papi reports grants from Chiesi, AstraZeneca, GSK, Sanofi, Agenzia Italiana del farmaco (AIFA); consulting fees from Chiesi, AstraZeneca, GSK, Novartis, Sanofi, Avillion, Elpen Pharmaceutica; lecture honoraria from Chiesi, AstraZeneca, GSK, Menarini, Novartis, Zambon, Munidpharma, Sanofi, Edmond Pharma, IQVIA, Avillion, Elpen Pharmaceuticals; advisory board participation with Chiesi, AstraZeneca, GSK, MSD, Novartis, Sanofi, IQVIA, AVILLION, Avillion, Elpen Pharmaceuticals; outside the submitted work.
Conflict of interest: Ioana Agache reports lecture honoraria from Stallergennes, Pfizer, Sanofi; advisory board participation with Pfizer;
Conflict of interest: Eugenio Baraldi reports lecture honoraria from AstraZeneca, Sanofi; outside the submitted work.
Conflict of interest: Richard Beasley reports grants AstraZeneca, Genentech, Health Research Council New Zealand; consulting fees, lecture honoraria, travel support and advisory board participation with AstraZeneca, Cipla, Avillion, Health Research Council New Zealand, CSL Seqirus, TEVA, outside the submitted work. Richard Beasley also reports the following leadership roles: Chair, Asthma and Respiratory Foundation NZ adolescent and adult asthma guidelines; Member, GOLD Board; Consultant, GINA.
Conflict of interest: Guy Brusselle reports lecture honoraria from Astra Zeneca, Boehringer-Ingelheim, Chiesi, GlaxoSmithKline, Novartis, MerckSharp&Dohme, Sanofi; outside the submitted work.
Conflict of interest: Mina Gaga reports a role as Alternate Minister of Health, Greece, outside the submitted work.
Conflict of interest: Erik Melén has received consulting fees from ALK, AstraZeneca, Chiesi, Novartis and Sanofi outside the submitted work.
Conflict of interest: Ian Pavord reports speaker fees from Aerocrine AB, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis, Regeneron Pharmaceuticals, Inc, Sanofi, Teva; consultant fees from Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Novartis, Regeneron Pharmaceuticals, Inc, Sanofi, Teva, Circassia, Dey Pharma, Genentech, Knopp Biosciences, Merck, MSD, Napp Pharmaceuticals, RespiVert, Schering-Plough; payments for organization of educational events from AstraZeneca, GSK, Regeneron Pharmaceuticals, Inc, Sanofi, Teva; international scientific meeting sponsorship from AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Regeneron Pharmaceuticals, Inc, Sanofi, Teva, Napp Pharmaceuticals; research grants from Chiesi; outside the submitted work.
Conflict of interest: Deborah Peñate Gómez works as PMO Analyst at Asthma and Lung UK.
Conflict of interest: Antonio Spanevello reports lecture honoraria, travel support and advisory board participation with Chiesi, AstraZeneca, GSK; outside the submitted work.
Conflict of interest: Thomy Tonia acts as ERS Methodologist.
Conflict of interest: Florence Schleich reports grants from GSK, Astrazeneca, Chiesi; lecture honoraria from GSK, Astrazeneca, Chiesi, TEVA; advisory board participation with GSK, Astrazeneca; outside the submitted work.
Conflict of interest: All other authors have nothing to disclose.
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- Received January 8, 2023.
- Accepted August 8, 2023.
- Copyright ©The authors 2023. For reproduction rights and permissions contact permissions{at}ersnet.org
