Budesonide/formoterol maintenance plus reliever therapy: a new strategy in pediatric asthma

Hans Bisgaard; Pascal Le Roux; Ditlef Bjåmer; Andrzej Dymek; Jan H Vermeulen; Christer Hultquist

doi:10.1378/chest.130.6.1733

Budesonide/formoterol maintenance plus reliever therapy: a new strategy in pediatric asthma

Hans Bisgaard, Pascal Le Roux, Ditlef Bjåmer, Andrzej Dymek, Jan H Vermeulen, Christer Hultquist

Dermatology and Allergy

264 Citations (Scopus)

Abstract

OBJECTIVES: A fixed combination of long-acting beta(2)-agonists (LABA) plus inhaled corticosteroids (ICS) has never been proven to reduce asthma exacerbations vs ICS alone in children. This 12-month, double-blind, randomized study in 341 children (age range, 4 to 11 years) with asthma uncontrolled on ICS investigated whether a novel regimen using budesonide/formoterol for maintenance and reliever therapy (Symbicort maintenance and relief therapy [SMART]) [Symbicort; AstraZeneca R&D, Lund, Sweden] could reduce exacerbations.

METHODS: Patients received SMART (budesonide/formoterol 80/4.5 microg qd maintenance plus additional inhalations for symptom relief), budesonide/formoterol 80/4.5 microg qd for maintenance (fixed combination), or higher-dose budesonide 320 microg qd (fixed-dose budesonide). Blinded as-needed medication (terbutaline 0.4 microg) was provided in both fixed-dose groups.

RESULTS: SMART prolonged the time to first exacerbation vs fixed-dose budesonide (p = 0.02) and fixed-dose combination (p < 0.001). Rates of exacerbation requiring medical intervention were reduced by 70 to 79% with SMART vs fixed-dose budesonide and fixed-dose combination (0.08/patient vs 0.28/patient and 0.40/patient, respectively; both p < 0.001). Mild exacerbation days and awakenings were significantly lower with SMART; yearly growth improved by 1.0 cm vs fixed-dose budesonide (p < 0.01).

CONCLUSION: The SMART regimen using budesonide/formoterol for both maintenance and as-needed symptom relief reduces the exacerbation rate compared with both fixed-dose combination and higher fixed-dose ICS alone in children with asthma.

Original language	English
Journal	Chest
Volume	130
Issue number	6
Pages (from-to)	1733-43
Number of pages	11
ISSN	0012-3692
DOIs	https://doi.org/10.1378/chest.130.6.1733
Publication status	Published - Dec 2006

Keywords

Adrenal Cortex Hormones
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Asthma
Budesonide
Child
Child, Preschool
Delayed-Action Preparations
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Drug Combinations
Drug Therapy, Combination
Ethanolamines
Female
Forced Expiratory Volume
Glucocorticoids
Humans
Male
Prospective Studies
Terbutaline

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10.1378/chest.130.6.1733

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@article{12276d94ab704990a21d81061d92a8d0,

title = "Budesonide/formoterol maintenance plus reliever therapy: a new strategy in pediatric asthma",

abstract = "OBJECTIVES: A fixed combination of long-acting beta(2)-agonists (LABA) plus inhaled corticosteroids (ICS) has never been proven to reduce asthma exacerbations vs ICS alone in children. This 12-month, double-blind, randomized study in 341 children (age range, 4 to 11 years) with asthma uncontrolled on ICS investigated whether a novel regimen using budesonide/formoterol for maintenance and reliever therapy (Symbicort maintenance and relief therapy [SMART]) [Symbicort; AstraZeneca R\&D, Lund, Sweden] could reduce exacerbations.METHODS: Patients received SMART (budesonide/formoterol 80/4.5 microg qd maintenance plus additional inhalations for symptom relief), budesonide/formoterol 80/4.5 microg qd for maintenance (fixed combination), or higher-dose budesonide 320 microg qd (fixed-dose budesonide). Blinded as-needed medication (terbutaline 0.4 microg) was provided in both fixed-dose groups.RESULTS: SMART prolonged the time to first exacerbation vs fixed-dose budesonide (p = 0.02) and fixed-dose combination (p < 0.001). Rates of exacerbation requiring medical intervention were reduced by 70 to 79\% with SMART vs fixed-dose budesonide and fixed-dose combination (0.08/patient vs 0.28/patient and 0.40/patient, respectively; both p < 0.001). Mild exacerbation days and awakenings were significantly lower with SMART; yearly growth improved by 1.0 cm vs fixed-dose budesonide (p < 0.01).CONCLUSION: The SMART regimen using budesonide/formoterol for both maintenance and as-needed symptom relief reduces the exacerbation rate compared with both fixed-dose combination and higher fixed-dose ICS alone in children with asthma.",

keywords = "Adrenal Cortex Hormones, Adrenergic beta-Agonists, Anti-Asthmatic Agents, Asthma, Budesonide, Child, Child, Preschool, Delayed-Action Preparations, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Drug Combinations, Drug Therapy, Combination, Ethanolamines, Female, Forced Expiratory Volume, Glucocorticoids, Humans, Male, Prospective Studies, Terbutaline",

author = "Hans Bisgaard and \{Le Roux\}, Pascal and Ditlef Bj{\aa}mer and Andrzej Dymek and Vermeulen, \{Jan H\} and Christer Hultquist",

year = "2006",

month = dec,

doi = "10.1378/chest.130.6.1733",

language = "English",

volume = "130",

pages = "1733--43",

journal = "Chest",

issn = "0012-3692",

publisher = "Elsevier Inc.",

number = "6",

}

TY - JOUR

T1 - Budesonide/formoterol maintenance plus reliever therapy

T2 - a new strategy in pediatric asthma

AU - Bisgaard, Hans

AU - Le Roux, Pascal

AU - Bjåmer, Ditlef

AU - Dymek, Andrzej

AU - Vermeulen, Jan H

AU - Hultquist, Christer

PY - 2006/12

Y1 - 2006/12

N2 - OBJECTIVES: A fixed combination of long-acting beta(2)-agonists (LABA) plus inhaled corticosteroids (ICS) has never been proven to reduce asthma exacerbations vs ICS alone in children. This 12-month, double-blind, randomized study in 341 children (age range, 4 to 11 years) with asthma uncontrolled on ICS investigated whether a novel regimen using budesonide/formoterol for maintenance and reliever therapy (Symbicort maintenance and relief therapy [SMART]) [Symbicort; AstraZeneca R&D, Lund, Sweden] could reduce exacerbations.METHODS: Patients received SMART (budesonide/formoterol 80/4.5 microg qd maintenance plus additional inhalations for symptom relief), budesonide/formoterol 80/4.5 microg qd for maintenance (fixed combination), or higher-dose budesonide 320 microg qd (fixed-dose budesonide). Blinded as-needed medication (terbutaline 0.4 microg) was provided in both fixed-dose groups.RESULTS: SMART prolonged the time to first exacerbation vs fixed-dose budesonide (p = 0.02) and fixed-dose combination (p < 0.001). Rates of exacerbation requiring medical intervention were reduced by 70 to 79% with SMART vs fixed-dose budesonide and fixed-dose combination (0.08/patient vs 0.28/patient and 0.40/patient, respectively; both p < 0.001). Mild exacerbation days and awakenings were significantly lower with SMART; yearly growth improved by 1.0 cm vs fixed-dose budesonide (p < 0.01).CONCLUSION: The SMART regimen using budesonide/formoterol for both maintenance and as-needed symptom relief reduces the exacerbation rate compared with both fixed-dose combination and higher fixed-dose ICS alone in children with asthma.

AB - OBJECTIVES: A fixed combination of long-acting beta(2)-agonists (LABA) plus inhaled corticosteroids (ICS) has never been proven to reduce asthma exacerbations vs ICS alone in children. This 12-month, double-blind, randomized study in 341 children (age range, 4 to 11 years) with asthma uncontrolled on ICS investigated whether a novel regimen using budesonide/formoterol for maintenance and reliever therapy (Symbicort maintenance and relief therapy [SMART]) [Symbicort; AstraZeneca R&D, Lund, Sweden] could reduce exacerbations.METHODS: Patients received SMART (budesonide/formoterol 80/4.5 microg qd maintenance plus additional inhalations for symptom relief), budesonide/formoterol 80/4.5 microg qd for maintenance (fixed combination), or higher-dose budesonide 320 microg qd (fixed-dose budesonide). Blinded as-needed medication (terbutaline 0.4 microg) was provided in both fixed-dose groups.RESULTS: SMART prolonged the time to first exacerbation vs fixed-dose budesonide (p = 0.02) and fixed-dose combination (p < 0.001). Rates of exacerbation requiring medical intervention were reduced by 70 to 79% with SMART vs fixed-dose budesonide and fixed-dose combination (0.08/patient vs 0.28/patient and 0.40/patient, respectively; both p < 0.001). Mild exacerbation days and awakenings were significantly lower with SMART; yearly growth improved by 1.0 cm vs fixed-dose budesonide (p < 0.01).CONCLUSION: The SMART regimen using budesonide/formoterol for both maintenance and as-needed symptom relief reduces the exacerbation rate compared with both fixed-dose combination and higher fixed-dose ICS alone in children with asthma.

KW - Adrenal Cortex Hormones

KW - Adrenergic beta-Agonists

KW - Anti-Asthmatic Agents

KW - Asthma

KW - Budesonide

KW - Child

KW - Child, Preschool

KW - Delayed-Action Preparations

KW - Dose-Response Relationship, Drug

KW - Double-Blind Method

KW - Drug Administration Schedule

KW - Drug Combinations

KW - Drug Therapy, Combination

KW - Ethanolamines

KW - Female

KW - Forced Expiratory Volume

KW - Glucocorticoids

KW - Humans

KW - Male

KW - Prospective Studies

KW - Terbutaline

UR - https://www.scopus.com/pages/publications/33845928663

U2 - 10.1378/chest.130.6.1733

DO - 10.1378/chest.130.6.1733

M3 - Journal article

C2 - 17166990

SN - 0012-3692

VL - 130

SP - 1733

EP - 1743

JO - Chest

JF - Chest

IS - 6

ER -

Budesonide/formoterol maintenance plus reliever therapy: a new strategy in pediatric asthma

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Keywords

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