دورية أكاديمية
Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma.
| العنوان: | Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. |
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| المؤلفون: | Papi A; From the Department of Respiratory Medicine, University of Ferrara Medical School, Ferrara, Italy (A.P.); the Capital Allergy and Respiratory Disease Center, Sacramento, CA (B.E.C.); the Medical Research Institute of New Zealand, Capital and Coast District Health Board, and Victoria University Wellington - all in Wellington, New Zealand (R.B.); Rutgers Institute for Translational Medicine and Science, Child Health Institute of New Jersey, Rutgers, the State University of New Jersey, New Brunswick (R.A.P.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.I.); BioPharmaceuticals Research and Development, AstraZeneca, Cambridge (M.C., L.D.), and Avillion, London (A.J.-E., R.R.) - both in the United Kingdom; BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (E.J.); BioPharmaceuticals Research and Development, AstraZeneca, Durham, NC (C.C.); and Avillion, Northbrook, IL (F.C.A.)., Chipps BE; From the Department of Respiratory Medicine, University of Ferrara Medical School, Ferrara, Italy (A.P.); the Capital Allergy and Respiratory Disease Center, Sacramento, CA (B.E.C.); the Medical Research Institute of New Zealand, Capital and Coast District Health Board, and Victoria University Wellington - all in Wellington, New Zealand (R.B.); Rutgers Institute for Translational Medicine and Science, Child Health Institute of New Jersey, Rutgers, the State University of New Jersey, New Brunswick (R.A.P.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.I.); BioPharmaceuticals Research and Development, AstraZeneca, Cambridge (M.C., L.D.), and Avillion, London (A.J.-E., R.R.) - both in the United Kingdom; BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (E.J.); BioPharmaceuticals Research and Development, AstraZeneca, Durham, NC (C.C.); and Avillion, Northbrook, IL (F.C.A.)., Beasley R; From the Department of Respiratory Medicine, University of Ferrara Medical School, Ferrara, Italy (A.P.); the Capital Allergy and Respiratory Disease Center, Sacramento, CA (B.E.C.); the Medical Research Institute of New Zealand, Capital and Coast District Health Board, and Victoria University Wellington - all in Wellington, New Zealand (R.B.); Rutgers Institute for Translational Medicine and Science, Child Health Institute of New Jersey, Rutgers, the State University of New Jersey, New Brunswick (R.A.P.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.I.); BioPharmaceuticals Research and Development, AstraZeneca, Cambridge (M.C., L.D.), and Avillion, London (A.J.-E., R.R.) - both in the United Kingdom; BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (E.J.); BioPharmaceuticals Research and Development, AstraZeneca, Durham, NC (C.C.); and Avillion, Northbrook, IL (F.C.A.)., Panettieri RA Jr; From the Department of Respiratory Medicine, University of Ferrara Medical School, Ferrara, Italy (A.P.); the Capital Allergy and Respiratory Disease Center, Sacramento, CA (B.E.C.); the Medical Research Institute of New Zealand, Capital and Coast District Health Board, and Victoria University Wellington - all in Wellington, New Zealand (R.B.); Rutgers Institute for Translational Medicine and Science, Child Health Institute of New Jersey, Rutgers, the State University of New Jersey, New Brunswick (R.A.P.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.I.); BioPharmaceuticals Research and Development, AstraZeneca, Cambridge (M.C., L.D.), and Avillion, London (A.J.-E., R.R.) - both in the United Kingdom; BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (E.J.); BioPharmaceuticals Research and Development, AstraZeneca, Durham, NC (C.C.); and Avillion, Northbrook, IL (F.C.A.)., Israel E; From the Department of Respiratory Medicine, University of Ferrara Medical School, Ferrara, Italy (A.P.); the Capital Allergy and Respiratory Disease Center, Sacramento, CA (B.E.C.); the Medical Research Institute of New Zealand, Capital and Coast District Health Board, and Victoria University Wellington - all in Wellington, New Zealand (R.B.); Rutgers Institute for Translational Medicine and Science, Child Health Institute of New Jersey, Rutgers, the State University of New Jersey, New Brunswick (R.A.P.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.I.); BioPharmaceuticals Research and Development, AstraZeneca, Cambridge (M.C., L.D.), and Avillion, London (A.J.-E., R.R.) - both in the United Kingdom; BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (E.J.); BioPharmaceuticals Research and Development, AstraZeneca, Durham, NC (C.C.); and Avillion, Northbrook, IL (F.C.A.)., Cooper M; From the Department of Respiratory Medicine, University of Ferrara Medical School, Ferrara, Italy (A.P.); the Capital Allergy and Respiratory Disease Center, Sacramento, CA (B.E.C.); the Medical Research Institute of New Zealand, Capital and Coast District Health Board, and Victoria University Wellington - all in Wellington, New Zealand (R.B.); Rutgers Institute for Translational Medicine and Science, Child Health Institute of New Jersey, Rutgers, the State University of New Jersey, New Brunswick (R.A.P.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.I.); BioPharmaceuticals Research and Development, AstraZeneca, Cambridge (M.C., L.D.), and Avillion, London (A.J.-E., R.R.) - both in the United Kingdom; BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (E.J.); BioPharmaceuticals Research and Development, AstraZeneca, Durham, NC (C.C.); and Avillion, Northbrook, IL (F.C.A.)., Dunsire L; From the Department of Respiratory Medicine, University of Ferrara Medical School, Ferrara, Italy (A.P.); the Capital Allergy and Respiratory Disease Center, Sacramento, CA (B.E.C.); the Medical Research Institute of New Zealand, Capital and Coast District Health Board, and Victoria University Wellington - all in Wellington, New Zealand (R.B.); Rutgers Institute for Translational Medicine and Science, Child Health Institute of New Jersey, Rutgers, the State University of New Jersey, New Brunswick (R.A.P.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.I.); BioPharmaceuticals Research and Development, AstraZeneca, Cambridge (M.C., L.D.), and Avillion, London (A.J.-E., R.R.) - both in the United Kingdom; BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (E.J.); BioPharmaceuticals Research and Development, AstraZeneca, Durham, NC (C.C.); and Avillion, Northbrook, IL (F.C.A.)., Jeynes-Ellis A; From the Department of Respiratory Medicine, University of Ferrara Medical School, Ferrara, Italy (A.P.); the Capital Allergy and Respiratory Disease Center, Sacramento, CA (B.E.C.); the Medical Research Institute of New Zealand, Capital and Coast District Health Board, and Victoria University Wellington - all in Wellington, New Zealand (R.B.); Rutgers Institute for Translational Medicine and Science, Child Health Institute of New Jersey, Rutgers, the State University of New Jersey, New Brunswick (R.A.P.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.I.); BioPharmaceuticals Research and Development, AstraZeneca, Cambridge (M.C., L.D.), and Avillion, London (A.J.-E., R.R.) - both in the United Kingdom; BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (E.J.); BioPharmaceuticals Research and Development, AstraZeneca, Durham, NC (C.C.); and Avillion, Northbrook, IL (F.C.A.)., Johnsson E; From the Department of Respiratory Medicine, University of Ferrara Medical School, Ferrara, Italy (A.P.); the Capital Allergy and Respiratory Disease Center, Sacramento, CA (B.E.C.); the Medical Research Institute of New Zealand, Capital and Coast District Health Board, and Victoria University Wellington - all in Wellington, New Zealand (R.B.); Rutgers Institute for Translational Medicine and Science, Child Health Institute of New Jersey, Rutgers, the State University of New Jersey, New Brunswick (R.A.P.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.I.); BioPharmaceuticals Research and Development, AstraZeneca, Cambridge (M.C., L.D.), and Avillion, London (A.J.-E., R.R.) - both in the United Kingdom; BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (E.J.); BioPharmaceuticals Research and Development, AstraZeneca, Durham, NC (C.C.); and Avillion, Northbrook, IL (F.C.A.)., Rees R; From the Department of Respiratory Medicine, University of Ferrara Medical School, Ferrara, Italy (A.P.); the Capital Allergy and Respiratory Disease Center, Sacramento, CA (B.E.C.); the Medical Research Institute of New Zealand, Capital and Coast District Health Board, and Victoria University Wellington - all in Wellington, New Zealand (R.B.); Rutgers Institute for Translational Medicine and Science, Child Health Institute of New Jersey, Rutgers, the State University of New Jersey, New Brunswick (R.A.P.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.I.); BioPharmaceuticals Research and Development, AstraZeneca, Cambridge (M.C., L.D.), and Avillion, London (A.J.-E., R.R.) - both in the United Kingdom; BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (E.J.); BioPharmaceuticals Research and Development, AstraZeneca, Durham, NC (C.C.); and Avillion, Northbrook, IL (F.C.A.)., Cappelletti C; From the Department of Respiratory Medicine, University of Ferrara Medical School, Ferrara, Italy (A.P.); the Capital Allergy and Respiratory Disease Center, Sacramento, CA (B.E.C.); the Medical Research Institute of New Zealand, Capital and Coast District Health Board, and Victoria University Wellington - all in Wellington, New Zealand (R.B.); Rutgers Institute for Translational Medicine and Science, Child Health Institute of New Jersey, Rutgers, the State University of New Jersey, New Brunswick (R.A.P.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.I.); BioPharmaceuticals Research and Development, AstraZeneca, Cambridge (M.C., L.D.), and Avillion, London (A.J.-E., R.R.) - both in the United Kingdom; BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (E.J.); BioPharmaceuticals Research and Development, AstraZeneca, Durham, NC (C.C.); and Avillion, Northbrook, IL (F.C.A.)., Albers FC; From the Department of Respiratory Medicine, University of Ferrara Medical School, Ferrara, Italy (A.P.); the Capital Allergy and Respiratory Disease Center, Sacramento, CA (B.E.C.); the Medical Research Institute of New Zealand, Capital and Coast District Health Board, and Victoria University Wellington - all in Wellington, New Zealand (R.B.); Rutgers Institute for Translational Medicine and Science, Child Health Institute of New Jersey, Rutgers, the State University of New Jersey, New Brunswick (R.A.P.); Brigham and Women's Hospital, Harvard Medical School, Boston (E.I.); BioPharmaceuticals Research and Development, AstraZeneca, Cambridge (M.C., L.D.), and Avillion, London (A.J.-E., R.R.) - both in the United Kingdom; BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (E.J.); BioPharmaceuticals Research and Development, AstraZeneca, Durham, NC (C.C.); and Avillion, Northbrook, IL (F.C.A.). |
| المصدر: | The New England journal of medicine [N Engl J Med] 2022 Jun 02; Vol. 386 (22), pp. 2071-2083. Date of Electronic Publication: 2022 May 15. |
| نوع المنشور: | Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Massachusetts Medical Society Country of Publication: United States NLM ID: 0255562 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1533-4406 (Electronic) Linking ISSN: 00284793 NLM ISO Abbreviation: N Engl J Med Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Boston, Massachusetts Medical Society. |
| مواضيع طبية MeSH: | Albuterol*/administration & dosage , Albuterol*/adverse effects , Albuterol*/therapeutic use , Asthma*/drug therapy , Budesonide*/administration & dosage , Budesonide*/adverse effects , Budesonide*/therapeutic use, Administration, Inhalation ; Adolescent ; Adult ; Child ; Child, Preschool ; Double-Blind Method ; Drug Combinations ; Ethanolamines/therapeutic use ; Formoterol Fumarate/therapeutic use ; Glucocorticoids/administration & dosage ; Glucocorticoids/adverse effects ; Glucocorticoids/therapeutic use ; Humans ; Maintenance Chemotherapy ; Nebulizers and Vaporizers ; Symptom Flare Up ; Young Adult |
| مستخلص: | Background: As asthma symptoms worsen, patients typically rely on short-acting β Methods: We conducted a multinational, phase 3, double-blind, randomized, event-driven trial to evaluate the efficacy and safety of albuterol-budesonide, as compared with albuterol alone, as rescue medication in patients with uncontrolled moderate-to-severe asthma who were receiving inhaled glucocorticoid-containing maintenance therapies, which were continued throughout the trial. Adults and adolescents (≥12 years of age) were randomly assigned in a 1:1:1 ratio to one of three trial groups: a fixed-dose combination of 180 μg of albuterol and 160 μg of budesonide (with each dose consisting of two actuations of 90 μg and 80 μg, respectively [the higher-dose combination group]), a fixed-dose combination of 180 μg of albuterol and 80 μg of budesonide (with each dose consisting of two actuations of 90 μg and 40 μg, respectively [the lower-dose combination group]), or 180 μg of albuterol (with each dose consisting of two actuations of 90 μg [the albuterol-alone group]). Children 4 to 11 years of age were randomly assigned to only the lower-dose combination group or the albuterol-alone group. The primary efficacy end point was the first event of severe asthma exacerbation in a time-to-event analysis, which was performed in the intention-to-treat population. Results: A total of 3132 patients underwent randomization, among whom 97% were 12 years of age or older. The risk of severe asthma exacerbation was significantly lower, by 26%, in the higher-dose combination group than in the albuterol-alone group (hazard ratio, 0.74; 95% confidence interval [CI], 0.62 to 0.89; P = 0.001). The hazard ratio in the lower-dose combination group, as compared with the albuterol-alone group, was 0.84 (95% CI, 0.71 to 1.00; P = 0.052). The incidence of adverse events was similar in the three trial groups. Conclusions: The risk of severe asthma exacerbation was significantly lower with as-needed use of a fixed-dose combination of 180 μg of albuterol and 160 μg of budesonide than with as-needed use of albuterol alone among patients with uncontrolled moderate-to-severe asthma who were receiving a wide range of inhaled glucocorticoid-containing maintenance therapies. (Funded by Avillion; MANDALA ClinicalTrials.gov number, NCT03769090.). (Copyright © 2022 Massachusetts Medical Society.) |
| التعليقات: | Comment in: N Engl J Med. 2022 Jun 2;386(22):2139-2140. (PMID: 35648708) Comment in: Ann Intern Med. 2022 Sep;175(9):JC106. (PMID: 36063557) Comment in: N Engl J Med. 2022 Aug 18;387(7):662-663. (PMID: 36070719) Comment in: J Pediatr. 2022 Dec;251:220-224. (PMID: 36464408) Comment in: MMW Fortschr Med. 2023 Feb;165(2):22-23. (PMID: 36703048) |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03769090 |
| المشرفين على المادة: | 0 (Drug Combinations) 0 (Ethanolamines) 0 (Glucocorticoids) 51333-22-3 (Budesonide) QF8SVZ843E (Albuterol) W34SHF8J2K (Formoterol Fumarate) |
| تواريخ الأحداث: | Date Created: 20220515 Date Completed: 20220603 Latest Revision: 20230131 |
| رمز التحديث: | 20230201 |
| DOI: | 10.1056/NEJMoa2203163 |
| PMID: | 35569035 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1533-4406 |
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| DOI: | 10.1056/NEJMoa2203163 |