Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials. Hatter, L., Houghton, C., Bruce, P., Holliday, M., Eathorne, A., Pavord, I., Reddel, H. K, Hancox, R. J, Braithwaite, I., Oldfield, K., Papi, A., Weatherall, M., & Beasley, R. BMJ Open Respiratory Research, 9(1):e001271, August, 2022.
Paper doi abstract bibtex Background In randomised controlled trials, as-needed inhaled corticosteroid (ICS)-formoterol reliever therapy reduces severe exacerbation risk compared with maintenance ICS plus short-acting beta 2 -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.
@article{hatter_asthma_2022,
title = {Asthma control with {ICS}-formoterol reliever versus maintenance {ICS} and {SABA} reliever therapy: a post hoc analysis of two randomised controlled trials},
volume = {9},
issn = {2052-4439},
shorttitle = {Asthma control with {ICS}-formoterol reliever versus maintenance {ICS} and {SABA} reliever therapy},
url = {https://bmjopenrespres.bmj.com/lookup/doi/10.1136/bmjresp-2022-001271},
doi = {10.1136/bmjresp-2022-001271},
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 beta
2
-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.},
language = {en},
number = {1},
urldate = {2024-05-30},
journal = {BMJ Open Respiratory Research},
author = {Hatter, Lee and Houghton, Claire and Bruce, Pepa and Holliday, Mark and Eathorne, Allie and Pavord, Ian and Reddel, Helen K and Hancox, Robert J and Braithwaite, Irene and Oldfield, Karen and Papi, Alberto and Weatherall, Mark and Beasley, Richard},
month = aug,
year = {2022},
pages = {e001271},
}
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{"_id":"BJexR8ygks83pB6Ah","bibbaseid":"hatter-houghton-bruce-holliday-eathorne-pavord-reddel-hancox-etal-asthmacontrolwithicsformoterolrelieverversusmaintenanceicsandsabarelievertherapyaposthocanalysisoftworandomisedcontrolledtrials-2022","author_short":["Hatter, L.","Houghton, C.","Bruce, P.","Holliday, M.","Eathorne, A.","Pavord, I.","Reddel, H. K","Hancox, R. J","Braithwaite, I.","Oldfield, K.","Papi, A.","Weatherall, M.","Beasley, R."],"bibdata":{"bibtype":"article","type":"article","title":"Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials","volume":"9","issn":"2052-4439","shorttitle":"Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy","url":"https://bmjopenrespres.bmj.com/lookup/doi/10.1136/bmjresp-2022-001271","doi":"10.1136/bmjresp-2022-001271","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 beta 2 -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.","language":"en","number":"1","urldate":"2024-05-30","journal":"BMJ Open Respiratory Research","author":[{"propositions":[],"lastnames":["Hatter"],"firstnames":["Lee"],"suffixes":[]},{"propositions":[],"lastnames":["Houghton"],"firstnames":["Claire"],"suffixes":[]},{"propositions":[],"lastnames":["Bruce"],"firstnames":["Pepa"],"suffixes":[]},{"propositions":[],"lastnames":["Holliday"],"firstnames":["Mark"],"suffixes":[]},{"propositions":[],"lastnames":["Eathorne"],"firstnames":["Allie"],"suffixes":[]},{"propositions":[],"lastnames":["Pavord"],"firstnames":["Ian"],"suffixes":[]},{"propositions":[],"lastnames":["Reddel"],"firstnames":["Helen","K"],"suffixes":[]},{"propositions":[],"lastnames":["Hancox"],"firstnames":["Robert","J"],"suffixes":[]},{"propositions":[],"lastnames":["Braithwaite"],"firstnames":["Irene"],"suffixes":[]},{"propositions":[],"lastnames":["Oldfield"],"firstnames":["Karen"],"suffixes":[]},{"propositions":[],"lastnames":["Papi"],"firstnames":["Alberto"],"suffixes":[]},{"propositions":[],"lastnames":["Weatherall"],"firstnames":["Mark"],"suffixes":[]},{"propositions":[],"lastnames":["Beasley"],"firstnames":["Richard"],"suffixes":[]}],"month":"August","year":"2022","pages":"e001271","bibtex":"@article{hatter_asthma_2022,\n\ttitle = {Asthma control with {ICS}-formoterol reliever versus maintenance {ICS} and {SABA} reliever therapy: a post hoc analysis of two randomised controlled trials},\n\tvolume = {9},\n\tissn = {2052-4439},\n\tshorttitle = {Asthma control with {ICS}-formoterol reliever versus maintenance {ICS} and {SABA} reliever therapy},\n\turl = {https://bmjopenrespres.bmj.com/lookup/doi/10.1136/bmjresp-2022-001271},\n\tdoi = {10.1136/bmjresp-2022-001271},\n\tabstract = {Background \n \n In randomised controlled trials, as-needed inhaled corticosteroid (ICS)-formoterol reliever therapy reduces severe exacerbation risk compared with maintenance ICS plus short-acting beta \n 2 \n -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. \n \n \n \n Objective \n 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. \n \n \n Methods \n 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. \n \n \n Results \n 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. \n \n \n Conclusions \n 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.},\n\tlanguage = {en},\n\tnumber = {1},\n\turldate = {2024-05-30},\n\tjournal = {BMJ Open Respiratory Research},\n\tauthor = {Hatter, Lee and Houghton, Claire and Bruce, Pepa and Holliday, Mark and Eathorne, Allie and Pavord, Ian and Reddel, Helen K and Hancox, Robert J and Braithwaite, Irene and Oldfield, Karen and Papi, Alberto and Weatherall, Mark and Beasley, Richard},\n\tmonth = aug,\n\tyear = {2022},\n\tpages = {e001271},\n}\n\n","author_short":["Hatter, L.","Houghton, C.","Bruce, P.","Holliday, M.","Eathorne, A.","Pavord, I.","Reddel, H. K","Hancox, R. J","Braithwaite, I.","Oldfield, K.","Papi, A.","Weatherall, M.","Beasley, R."],"key":"hatter_asthma_2022","id":"hatter_asthma_2022","bibbaseid":"hatter-houghton-bruce-holliday-eathorne-pavord-reddel-hancox-etal-asthmacontrolwithicsformoterolrelieverversusmaintenanceicsandsabarelievertherapyaposthocanalysisoftworandomisedcontrolledtrials-2022","role":"author","urls":{"Paper":"https://bmjopenrespres.bmj.com/lookup/doi/10.1136/bmjresp-2022-001271"},"metadata":{"authorlinks":{}}},"bibtype":"article","biburl":"https://api.zotero.org/users/6607533/collections/VKGURBGN/items?key=hSjrOPQRRHHWY81SKs6CEz45&format=bibtex&limit=100","dataSources":["upP78A3qvEd6tbHFm","zpWcq5jS35za3AmLx"],"keywords":[],"search_terms":["asthma","control","ics","formoterol","reliever","versus","maintenance","ics","saba","reliever","therapy","post","hoc","analysis","two","randomised","controlled","trials","hatter","houghton","bruce","holliday","eathorne","pavord","reddel","hancox","braithwaite","oldfield","papi","weatherall","beasley"],"title":"Asthma control with ICS-formoterol reliever versus maintenance ICS and SABA reliever therapy: a post hoc analysis of two randomised controlled trials","year":2022}