Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials
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 asthm...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-08-01
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| Series: | BMJ Open Respiratory Research |
| Online Access: | https://bmjopenrespres.bmj.com/content/9/1/e001271.full |
| _version_ | 1798036587539333120 |
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| 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 Pepa Bruce |
| author_facet | 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 Pepa Bruce |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T21:15:03Z |
| format | Article |
| id | doaj.art-adb631a75424488db9d58a80c53835d0 |
| institution | Directory Open Access Journal |
| issn | 2052-4439 |
| language | English |
| last_indexed | 2024-04-11T21:15:03Z |
| publishDate | 2022-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Respiratory Research |
| spelling | doaj.art-adb631a75424488db9d58a80c53835d02022-12-22T04:02:52ZengBMJ Publishing GroupBMJ Open Respiratory Research2052-44392022-08-019110.1136/bmjresp-2022-001271Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials 0James Fingleton1Mark Weatherall2Richard Beasley3Irene Braithwaite4Ian Pavord5Jenny Sparks6Lee Hatter7Helen K Reddel8Robert J Hancox9Mark Holliday10Andrew CorinDaniela HallClaire Houghton11Saras ManeJohn Martindale12Karen Oldfield13Donah Sabbagh14Alexandra VohlidkovaAlberto Papi15Allie Eathorne16Pepa Bruce173International CollaborationMedical Research Institute of New Zealand, Wellington, New ZealandMedicine, University of Otago Wellington, Wellington, New ZealandMedical Research Institute of New Zealand, Wellington, New ZealandMedical Research Institute of New Zealand, Wellington, New ZealandRespiratory Medicine Unit and Oxford Respiratory NIHR Biomedical Research Centre, University of Oxford, Oxford, UKMedical Research Institute of New Zealand, Wellington, New Zealand1University College London, UKNHMRC Centre of Excellence in Severe Asthma, New Lambton, New South Wales, AustraliaUniversity of Otago, Dunedin, New ZealandMedical Research Institute of New Zealand, Wellington, New ZealandMedical Research Institute of New Zealand, Wellington, New ZealandMedical Research Institute of New Zealand, Wellington, New Zealand1 Medical Research Institute of New Zealand, Wellington, New ZealandMedical Research Institute of New Zealand, Wellington, New ZealandRespiratory Medicine, University of Ferrara, Ferrara, ItalyMedical Research Institute of New Zealand, Wellington, New ZealandMedical Research Institute of New Zealand, Wellington, New ZealandBackground 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.https://bmjopenrespres.bmj.com/content/9/1/e001271.full |
| spellingShingle | 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 Pepa Bruce Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials BMJ Open Respiratory Research |
| title | Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials |
| title_full | Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials |
| title_fullStr | Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials |
| title_full_unstemmed | Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials |
| title_short | Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials |
| title_sort | asthma control with ics formoterol reliever versus maintenance ics and saba reliever therapy a post hoc analysis of two randomised controlled trials |
| url | https://bmjopenrespres.bmj.com/content/9/1/e001271.full |
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