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formoterol reduces the risk of severe exacerbations compared with budesonide plus terbutaline as needed in patients with asthma
S116 Abstracts
J ALLERGY CLIN IMMUNOL FEBRUARY 2004
SUNDAY
363
Single Inhaler Therapy With Budesonide/Formoterol Reduces the Risk of Severe Exacerbations Compared With Budesonide Plus Terbutaline As Needed in Patients With Asthma
R. Scicchitano1, R. Aalbers2, D. Ukena3, A. I. Manjra4, L. Fouquert5, S. Centanni6, L. Boulet7; 1Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, AUSTRALIA, 2Department of Pulmonology, Martini Hospital, Groningen, NETHERLANDS, 3University Hospital, Homburg, GERMANY, 4Westville Hospital, Westville, Durban, SOUTH AFRICA, 5Medical Practice, Grasse, FRANCE, 6Respiratory Unit, San Paolo Hospital, University of Milan, Milan, ITALY, 7The Laval University Cardiothoracic Institute, Laval Hospital, Quebec City, PQ, CANADA. RATIONALE: We hypothesized that a once-daily base dose of budesonide/formoterol in a single inhaler (Symbicort®), plus additional doses as needed to provide improved control and immediate relief of symptoms (Single inhaler Therapy), would reduce the risk of severe exacerbations compared with a higher fixed dose of budesonide plus as-needed terbutaline. METHODS: This was a 12-month, randomized, double-blind, parallelgroup study. Symptomatic patients (n=1890; mean age 43 [range 11-80] years, mean baseline FEV1 70% predicted normal, mean ICS dose 746µg/day) received either a daily base dose of budesonide/formoterol (160/4.5µg, 2 inhalations once daily) with additional inhalations (=10/day) as needed for relief of symptoms, or budesonide (160µg, 2 inhalations twice daily) plus as-needed terbutaline 0.4mg. We assessed the risk of severe exacerbations (defined as hospitalization/emergency room [ER] treatment, oral steroids due to asthma worsening, or morning PEF=70% of baseline on 2 consecutive days), as-needed medication use, and tolerability. RESULTS: The budesonide/formoterol group had a 39% lower risk of a severe exacerbation compared with the budesonide group (p<0.001). Budesonide/formoterol patients had 40% fewer hospitalizations/ER treatments compared with budesonide patients (15 vs 25 events, respectively) and 44% fewer oral steroid treatment days (1776 vs 3177 days, respectively). Budesonide/formoterol patients took significantly fewer as-needed inhalations during the treatment period compared with budesonide patients (0.90 vs 1.42 inhalations/day; p<0.001). Both treatments were well tolerated. CONCLUSIONS: Single inhaler Therapy with a once-daily base dose of budesonide/formoterol plus additional inhalations as needed significantly reduces the risk of severe exacerbations compared with a higher fixed dose of budesonide plus terbutaline. Funding: AstraZeneca
J ALLERGY CLIN IMMUNOL FEBRUARY 2004
SUNDAY
363
Single Inhaler Therapy With Budesonide/Formoterol Reduces the Risk of Severe Exacerbations Compared With Budesonide Plus Terbutaline As Needed in Patients With Asthma
R. Scicchitano1, R. Aalbers2, D. Ukena3, A. I. Manjra4, L. Fouquert5, S. Centanni6, L. Boulet7; 1Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, AUSTRALIA, 2Department of Pulmonology, Martini Hospital, Groningen, NETHERLANDS, 3University Hospital, Homburg, GERMANY, 4Westville Hospital, Westville, Durban, SOUTH AFRICA, 5Medical Practice, Grasse, FRANCE, 6Respiratory Unit, San Paolo Hospital, University of Milan, Milan, ITALY, 7The Laval University Cardiothoracic Institute, Laval Hospital, Quebec City, PQ, CANADA. RATIONALE: We hypothesized that a once-daily base dose of budesonide/formoterol in a single inhaler (Symbicort®), plus additional doses as needed to provide improved control and immediate relief of symptoms (Single inhaler Therapy), would reduce the risk of severe exacerbations compared with a higher fixed dose of budesonide plus as-needed terbutaline. METHODS: This was a 12-month, randomized, double-blind, parallelgroup study. Symptomatic patients (n=1890; mean age 43 [range 11-80] years, mean baseline FEV1 70% predicted normal, mean ICS dose 746µg/day) received either a daily base dose of budesonide/formoterol (160/4.5µg, 2 inhalations once daily) with additional inhalations (=10/day) as needed for relief of symptoms, or budesonide (160µg, 2 inhalations twice daily) plus as-needed terbutaline 0.4mg. We assessed the risk of severe exacerbations (defined as hospitalization/emergency room [ER] treatment, oral steroids due to asthma worsening, or morning PEF=70% of baseline on 2 consecutive days), as-needed medication use, and tolerability. RESULTS: The budesonide/formoterol group had a 39% lower risk of a severe exacerbation compared with the budesonide group (p<0.001). Budesonide/formoterol patients had 40% fewer hospitalizations/ER treatments compared with budesonide patients (15 vs 25 events, respectively) and 44% fewer oral steroid treatment days (1776 vs 3177 days, respectively). Budesonide/formoterol patients took significantly fewer as-needed inhalations during the treatment period compared with budesonide patients (0.90 vs 1.42 inhalations/day; p<0.001). Both treatments were well tolerated. CONCLUSIONS: Single inhaler Therapy with a once-daily base dose of budesonide/formoterol plus additional inhalations as needed significantly reduces the risk of severe exacerbations compared with a higher fixed dose of budesonide plus terbutaline. Funding: AstraZeneca