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1. Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials

Author

James Fingleton, Mark Weatherall, Richard Beasley, Irene Braithwaite, Ian Pavord, Jenny Sparks, Lee Hatter, Helen K Reddel, Robert J Hancox, Mark Holliday, Andrew Corin, Daniela Hall, Claire Houghton, Saras Mane, John Martindale, Karen Oldfield, Donah Sabbagh, Alexandra Vohlidkova, Alberto Papi, Allie Eathorne, and Pepa Bruce

Subjects
Medicine, Diseases of the respiratory system, RC705-779
Abstract

Background In randomised controlled trials, as-needed inhaled corticosteroid (ICS)-formoterol reliever therapy reduces severe exacerbation risk compared with maintenance ICS plus short-acting beta2-agonist (SABA) reliever in adolescent and adult asthma, but results in slightly worse control of asthma symptoms, as measured by mean Asthma Control Questionnaire-5 (ACQ-5) score.Objective To assess the levels and changes in asthma control for as-needed budesonide–formoterol versus maintenance budesonide plus SABA in post hoc analyses from the Novel START and PRACTICAL clinical trials.Methods The number and proportion of participants at study end in each ACQ-5 category (‘well-controlled’, ‘partly controlled’ or ‘inadequately controlled’ symptoms), and in each responder category based on the minimal clinically important difference for ACQ-5 of 0.5 (improved, no change and worse) with as-needed budesonide–formoterol and maintenance budesonide plus SABA treatment were calculated.Results With last observation carried forwards, 189/214 (88.3%) and 354/434 (81.6%) of patients in the budesonide–formoterol group had ‘well-controlled’ or ‘partly controlled’ symptoms at the end of the study, vs 183/214 (85.5%) and 358/431 (83.1%) in the budesonide maintenance group, for Novel START and PRACTICAL, respectively. The proportion of patients whose symptom control was either improved or unchanged from baseline was 190/214 (88.8%) and 368/434 (84.8%) for budesonide–formoterol, vs 185/214 (86.4%) and 376/431 (87.2%) for maintenance budesonide, in Novel START and PRACTICAL respectively.Conclusions There were no clinically important differences in the proportions of patients with ‘well-controlled’ or ‘partly controlled’ asthma symptoms, or proportions who improved or maintained their level of control, with as-needed budesonide–formoterol versus maintenance budesonide plus SABA.

Published
2022
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2. Predictive value of blood eosinophils and exhaled nitric oxide in adults with mild asthma: a prespecified subgroup analysis of an open-label, parallel-group, randomised controlled trial

Author

Ian D Pavord, Mark Holliday, Helen K Reddel, Irene Braithwaite, Stefan Ebmeier, Robert J Hancox, Tim Harrison, Claire Houghton, Karen Oldfield, Alberto Papi, Mathew Williams, Mark Weatherall, Richard Beasley, Andrew Corin, Colin Helm, Bhuwan Poudel, Davitt Sheahan, Pamela Sheahan, Miriam Bennett, Caterina Chang, Hollie Ellis, Bob Hancox, Sandra Hopping, Christine Tuffery, James Michael Ramsahai, Jodie Simpson, Peter Wark, Maria Aliani, Maddalena Genco, Alberto Capozzolo, Mauro Carone, Elisa Maini, Jenny Mancin, Antonio Meriggi, Luca Perfetti, Francesca Cherubino, Antonio Spanevello, Dina Visca, Elisabetta Zampogna, Christina Baggott, Allie Eathorne, James Fingleton, Jo Hardy, Janine Pilcher, Donah Sabbagh, Alex Semprini, Karen Shaw, Summer Mackisack, Barney Montgomery, Karen Autridge, Joanna Joseph, Stella Moon, Dean Quinn, Dean Millar-Coote, Jim Reid, Federico Bellini, Martina Marchi, Luca Morandi, Marianna Padovani, Daniela Scalet, Katie Borg, Clare Connolly, Anna Gittins, Gareth Hynes, Helen Jeffers, Ian Pavord, Rahul Shrimanker, Gloria Foxley, Elyse Guevara-Rattray, Stephen Milne, Helen Reddel, and Brett Toelle

Subjects
Pulmonary and Respiratory Medicine, Budesonide, Adult, Male, medicine.medical_specialty, parallel-group, Exacerbation, blood eosinophils, Socio-culturale, formoterol, Subgroup analysis, open-label, Nitric Oxide, 03 medical and health sciences, Leukocyte Count, Young Adult, 0302 clinical medicine, Predictive Value of Tests, Internal medicine, Formoterol Fumarate, medicine, mild asthma, blood eosinophils, exhaled nitric oxide, open-label, parallel-group, randomised controlled trial, salbutamol, budesonide, formoterol, Humans, Albuterol, 030212 general & internal medicine, business.industry, Inhaler, respiratory system, Middle Aged, Metered-dose inhaler, Asthma, respiratory tract diseases, Bronchodilator Agents, Eosinophils, Treatment Outcome, 030228 respiratory system, Exhalation, salbutamol, Exhaled nitric oxide, Salbutamol, exhaled nitric oxide, Female, Formoterol, business, randomised controlled trial, medicine.drug, mild asthma
Abstract

Summary Background Whether blood eosinophil counts and exhaled nitric oxide (FeNO) are associated with important outcomes in mild asthma is unclear. In this prespecified subgroup analysis of a previously published open-label clinical trial, we aimed to assess associations between blood eosinophil counts and FeNO with outcomes and response to asthma treatment. Methods In the previously reported 52-week, open-label, randomised controlled trial, people with mild asthma receiving only β agonist reliever inhalers were enrolled at one of 16 clinical trials units in New Zealand, the UK, Italy, or Australia. Eligible participants were randomly assigned (1:1:1, stratified by country), to receive inhalers to take as-needed salbutamol (two inhalations of 100 μg in a pressurised metered dose inhaler), maintenance budesonide (200 μg twice per day by inhaler) plus as-needed salbutamol (two inhalations of 100 μg), or as-needed budesonide–formoterol (one inhalation of 200 μg budesonide and 6μg formoterol by inhaler). The primary outcome was the annual rates of asthma exacerbations per patient, and in this prespecified subgroup analysis, we assessed whether annual exacerbation rates in each treatment group were significantly different depending on levels of blood eosinophil count, FeNO, or a composite score of both. Analyses were done for patients with available biomarker measurements The study was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12615000999538. Findings 675 participants were enrolled between March 17, 2016, and Aug 29, 2017, of whom 656 had results for blood eosinophil analysis and 668 had results for FeNO. Of the patients who received as-needed salbutamol, the proportion of patients having a severe exacerbation increased progressively with increasing blood eosinophil count (two [4%] of 49 participants with Interpretation In patients with mild asthma, the effects of as-needed budesonide–formoterol on exacerbations are independent of biomarker profile, whereas the benefits of maintenance inhaled budesonide are greater in patients with high blood eosinophil counts than in patients with low counts. Funding AstraZeneca, Health Research Council of New Zealand.

Published
2019

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