@article{kearns_single_2022,
	title = {Single dose of budesonide/formoterol turbuhaler compared to salbutamol {pMDI} for speed of bronchodilator onset in asthma: a randomised cross-over trial},
	issn = {1468-3296},
	shorttitle = {Single dose of budesonide/formoterol turbuhaler compared to salbutamol {pMDI} for speed of bronchodilator onset in asthma},
	doi = {10.1136/thorax-2022-219052},
	abstract = {OBJECTIVE: To compare bronchodilator response after to salbutamol and budesonide/formoterol in adults with stable asthma.
METHODS: A double-blind, cross-over, single-centre, placebo-controlled, non-inferiority trial. Adults with stable asthma were randomised to different orders of two treatment regimens: two actuations of placebo via MDI and one actuation of budesonide/formoterol 200/6 µg via turbuhaler; and one actuation of placebo turbuhaler and two actuations of salbutamol 100 µg via MDI. The primary outcome measure was FEV1 after 2 min. Secondary outcome measures included FEV1, mBorg Dyspnoea Scale score and visual analogue score for breathlessness over 30 min.
RESULTS: Forty-nine of 50 potential participants were randomised. One participant withdrew following the first intervention visit and another could not be randomised due to COVID-19 restrictions. The mean (SD) change from baseline FEV1 2 min after treatment administration for budesonide/formoterol and salbutamol was 0.08 (0.14) L, n=49, and 0.17 (0.18) L, n=48, respectively, mean (95\% CI) paired difference of -0.097 L (-0.147 to -0.047), p=0.07, against a non-inferiority bound of -0.06 L. In the secondary analysis, FEV1 over 30 min was lower for budesonide/formoterol compared with salbutamol, difference (95\% CI): -0.10 (-0.12 to -0.08) L, p{\textless}0.001. There were no differences in Visual Analogue Scale score or mBorg Dyspnoea Scale score between treatments.
CONCLUSION: The results do not support the primary hypothesis of non-inferiority at the boundary of -0.06 L for the difference between budesonide/formoterol 200/6 µg compared with salbutamol 200 µg for FEV1 at 2 min, and could be consistent with inferiority with a p value of 0.07. For the secondary analysis of FEV1 measurements over time, the FEV1 was higher with salbutamol.
TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry (ACTRN 12619001387112).},
	language = {eng},
	journal = {Thorax},
	author = {Kearns, Nethmi and Williams, Mathew and Bruce, Pepa and Black, Melissa and Kearns, Ciléin and Sparks, Jenny and Braithwaite, Irene and Weatherall, Mark and Beasley, Richard},
	month = jul,
	year = {2022},
	pmid = {35851045},
	keywords = {asthma, inhaler devices},
	pages = {thoraxjnl--2022--219052},
}

{"_id":"oXMan3Pt9BiugxHCY","bibbaseid":"kearns-williams-bruce-black-kearns-sparks-braithwaite-weatherall-etal-singledoseofbudesonideformoterolturbuhalercomparedtosalbutamolpmdiforspeedofbronchodilatoronsetinasthmaarandomisedcrossovertrial-2022","author_short":["Kearns, N.","Williams, M.","Bruce, P.","Black, M.","Kearns, C.","Sparks, J.","Braithwaite, I.","Weatherall, M.","Beasley, R."],"bibdata":{"bibtype":"article","type":"article","title":"Single dose of budesonide/formoterol turbuhaler compared to salbutamol pMDI for speed of bronchodilator onset in asthma: a randomised cross-over trial","issn":"1468-3296","shorttitle":"Single dose of budesonide/formoterol turbuhaler compared to salbutamol pMDI for speed of bronchodilator onset in asthma","doi":"10.1136/thorax-2022-219052","abstract":"OBJECTIVE: To compare bronchodilator response after to salbutamol and budesonide/formoterol in adults with stable asthma. METHODS: A double-blind, cross-over, single-centre, placebo-controlled, non-inferiority trial. Adults with stable asthma were randomised to different orders of two treatment regimens: two actuations of placebo via MDI and one actuation of budesonide/formoterol 200/6 µg via turbuhaler; and one actuation of placebo turbuhaler and two actuations of salbutamol 100 µg via MDI. The primary outcome measure was FEV1 after 2 min. Secondary outcome measures included FEV1, mBorg Dyspnoea Scale score and visual analogue score for breathlessness over 30 min. RESULTS: Forty-nine of 50 potential participants were randomised. One participant withdrew following the first intervention visit and another could not be randomised due to COVID-19 restrictions. The mean (SD) change from baseline FEV1 2 min after treatment administration for budesonide/formoterol and salbutamol was 0.08 (0.14) L, n=49, and 0.17 (0.18) L, n=48, respectively, mean (95% CI) paired difference of -0.097 L (-0.147 to -0.047), p=0.07, against a non-inferiority bound of -0.06 L. In the secondary analysis, FEV1 over 30 min was lower for budesonide/formoterol compared with salbutamol, difference (95% CI): -0.10 (-0.12 to -0.08) L, p\\textless0.001. There were no differences in Visual Analogue Scale score or mBorg Dyspnoea Scale score between treatments. CONCLUSION: The results do not support the primary hypothesis of non-inferiority at the boundary of -0.06 L for the difference between budesonide/formoterol 200/6 µg compared with salbutamol 200 µg for FEV1 at 2 min, and could be consistent with inferiority with a p value of 0.07. For the secondary analysis of FEV1 measurements over time, the FEV1 was higher with salbutamol. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry (ACTRN 12619001387112).","language":"eng","journal":"Thorax","author":[{"propositions":[],"lastnames":["Kearns"],"firstnames":["Nethmi"],"suffixes":[]},{"propositions":[],"lastnames":["Williams"],"firstnames":["Mathew"],"suffixes":[]},{"propositions":[],"lastnames":["Bruce"],"firstnames":["Pepa"],"suffixes":[]},{"propositions":[],"lastnames":["Black"],"firstnames":["Melissa"],"suffixes":[]},{"propositions":[],"lastnames":["Kearns"],"firstnames":["Ciléin"],"suffixes":[]},{"propositions":[],"lastnames":["Sparks"],"firstnames":["Jenny"],"suffixes":[]},{"propositions":[],"lastnames":["Braithwaite"],"firstnames":["Irene"],"suffixes":[]},{"propositions":[],"lastnames":["Weatherall"],"firstnames":["Mark"],"suffixes":[]},{"propositions":[],"lastnames":["Beasley"],"firstnames":["Richard"],"suffixes":[]}],"month":"July","year":"2022","pmid":"35851045","keywords":"asthma, inhaler devices","pages":"thoraxjnl–2022–219052","bibtex":"@article{kearns_single_2022,\n\ttitle = {Single dose of budesonide/formoterol turbuhaler compared to salbutamol {pMDI} for speed of bronchodilator onset in asthma: a randomised cross-over trial},\n\tissn = {1468-3296},\n\tshorttitle = {Single dose of budesonide/formoterol turbuhaler compared to salbutamol {pMDI} for speed of bronchodilator onset in asthma},\n\tdoi = {10.1136/thorax-2022-219052},\n\tabstract = {OBJECTIVE: To compare bronchodilator response after to salbutamol and budesonide/formoterol in adults with stable asthma.\nMETHODS: A double-blind, cross-over, single-centre, placebo-controlled, non-inferiority trial. Adults with stable asthma were randomised to different orders of two treatment regimens: two actuations of placebo via MDI and one actuation of budesonide/formoterol 200/6 µg via turbuhaler; and one actuation of placebo turbuhaler and two actuations of salbutamol 100 µg via MDI. The primary outcome measure was FEV1 after 2 min. Secondary outcome measures included FEV1, mBorg Dyspnoea Scale score and visual analogue score for breathlessness over 30 min.\nRESULTS: Forty-nine of 50 potential participants were randomised. One participant withdrew following the first intervention visit and another could not be randomised due to COVID-19 restrictions. The mean (SD) change from baseline FEV1 2 min after treatment administration for budesonide/formoterol and salbutamol was 0.08 (0.14) L, n=49, and 0.17 (0.18) L, n=48, respectively, mean (95\\% CI) paired difference of -0.097 L (-0.147 to -0.047), p=0.07, against a non-inferiority bound of -0.06 L. In the secondary analysis, FEV1 over 30 min was lower for budesonide/formoterol compared with salbutamol, difference (95\\% CI): -0.10 (-0.12 to -0.08) L, p{\\textless}0.001. There were no differences in Visual Analogue Scale score or mBorg Dyspnoea Scale score between treatments.\nCONCLUSION: The results do not support the primary hypothesis of non-inferiority at the boundary of -0.06 L for the difference between budesonide/formoterol 200/6 µg compared with salbutamol 200 µg for FEV1 at 2 min, and could be consistent with inferiority with a p value of 0.07. For the secondary analysis of FEV1 measurements over time, the FEV1 was higher with salbutamol.\nTRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry (ACTRN 12619001387112).},\n\tlanguage = {eng},\n\tjournal = {Thorax},\n\tauthor = {Kearns, Nethmi and Williams, Mathew and Bruce, Pepa and Black, Melissa and Kearns, Ciléin and Sparks, Jenny and Braithwaite, Irene and Weatherall, Mark and Beasley, Richard},\n\tmonth = jul,\n\tyear = {2022},\n\tpmid = {35851045},\n\tkeywords = {asthma, inhaler devices},\n\tpages = {thoraxjnl--2022--219052},\n}\n\n","author_short":["Kearns, N.","Williams, M.","Bruce, P.","Black, M.","Kearns, C.","Sparks, J.","Braithwaite, I.","Weatherall, M.","Beasley, R."],"key":"kearns_single_2022","id":"kearns_single_2022","bibbaseid":"kearns-williams-bruce-black-kearns-sparks-braithwaite-weatherall-etal-singledoseofbudesonideformoterolturbuhalercomparedtosalbutamolpmdiforspeedofbronchodilatoronsetinasthmaarandomisedcrossovertrial-2022","role":"author","urls":{},"keyword":["asthma","inhaler devices"],"metadata":{"authorlinks":{}}},"bibtype":"article","biburl":"https://api.zotero.org/users/6607533/collections/VKGURBGN/items?key=hSjrOPQRRHHWY81SKs6CEz45&format=bibtex&limit=100","dataSources":["upP78A3qvEd6tbHFm","zpWcq5jS35za3AmLx"],"keywords":["asthma","inhaler devices"],"search_terms":["single","dose","budesonide","formoterol","turbuhaler","compared","salbutamol","pmdi","speed","bronchodilator","onset","asthma","randomised","cross","over","trial","kearns","williams","bruce","black","kearns","sparks","braithwaite","weatherall","beasley"],"title":"Single dose of budesonide/formoterol turbuhaler compared to salbutamol pMDI for speed of bronchodilator onset in asthma: a randomised cross-over trial","year":2022}