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Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma.
Papi, Alberto; Chipps, Bradley E; Beasley, Richard; Panettieri, Reynold A; Israel, Elliot; Cooper, Mark; Dunsire, Lynn; Jeynes-Ellis, Allison; Johnsson, Eva; Rees, Robert; Cappelletti, Christy; Albers, Frank C.
Affiliation
  • 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 Welli
  • 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 Welli
  • 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 Welli
  • Panettieri RA; 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 Welli
  • 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 Welli
  • 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 Welli
  • 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 Welli
  • 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 Welli
  • 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 Welli
  • 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 Welli
  • 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 Welli
  • 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 Welli
N Engl J Med ; 386(22): 2071-2083, 2022 06 02.
Article in En | MEDLINE | ID: mdl-35569035
ABSTRACT

BACKGROUND:

As asthma symptoms worsen, patients typically rely on short-acting ß2-agonist (SABA) rescue therapy, but SABAs do not address worsening inflammation, which leaves patients at risk for severe asthma exacerbations. The use of a fixed-dose combination of albuterol and budesonide, as compared with albuterol alone, as rescue medication might reduce the risk of severe asthma exacerbation.

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 111 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.).
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Full text: 1 Database: MEDLINE Main subject: Asthma / Budesonide / Albuterol Type of study: Clinical_trials Limits: Adolescent / Adult / Child / Child, preschool / Humans Language: En Journal: N Engl J Med Year: 2022 Type: Article
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Full text: 1 Database: MEDLINE Main subject: Asthma / Budesonide / Albuterol Type of study: Clinical_trials Limits: Adolescent / Adult / Child / Child, preschool / Humans Language: En Journal: N Engl J Med Year: 2022 Type: Article