The Inhaled Steroid Treatment As Regular Therapy in Early Asthma (START) study 5-year follow-up

Effectiveness of early intervention with budesonide in mild persistent asthma

START Investigators Group, START investigators (and numbers of patients recruited) by country

Research output: Contribution to journalArticle

95 Citations (Scopus)

Abstract

Background: The Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START) study enrolled 7241 patients aged 5 to 66 years with recent-onset, mild persistent asthma to assess early intervention with the inhaled corticosteroid budesonide on long-term asthma control. Objective: The open-label phase of the START study was included to determine the effect on lung function and asthma control of adding budesonide to the reference group patients who had not initially received inhaled corticosteroids. Methods: Patients were randomized to double-blind treatment with budesonide, 200 mg (those aged <11 years) or 400 mg once daily, or placebo plus the usual asthma therapy for 3 years, after which all patients received 2 years of open-label treatment with budesonide once daily. Results: During the full 5-year study period, postbronchodilator FEV1 percent predicted decreased, irrespective of randomized treatment during the double-blind phase, by an average of 2.22% (SE, 0.15%). However, patients with inhaled budesonide in the double-blind phase had a significantly lower risk (odds ratio, 0.61; P <.001) of a severe asthma-related event during the full 5-year study period than those in the reference group. Moreover, patients in the reference group used more additional asthma medications during both the open-label and double-blind phases. Conclusions: In mild persistent asthma early intervention with inhaled budesonide was associated with improved asthma control and less additional asthma medication use.

Original languageEnglish
Pages (from-to)1167-1174
Number of pages8
JournalJournal of Allergy and Clinical Immunology
Volume121
Issue number5
DOIs
Publication statusPublished - Jan 1 2008
Externally publishedYes

Fingerprint

Budesonide
Asthma
Steroids
Therapeutics
Adrenal Cortex Hormones
Odds Ratio
Placebos

Keywords

  • budesonide dry-powder inhaler
  • inhaled corticosteroid
  • Mild persistent asthma
  • recent-onset asthma

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

The Inhaled Steroid Treatment As Regular Therapy in Early Asthma (START) study 5-year follow-up : Effectiveness of early intervention with budesonide in mild persistent asthma. / START Investigators Group; START investigators (and numbers of patients recruited) by country.

In: Journal of Allergy and Clinical Immunology, Vol. 121, No. 5, 01.01.2008, p. 1167-1174.

Research output: Contribution to journalArticle

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title = "The Inhaled Steroid Treatment As Regular Therapy in Early Asthma (START) study 5-year follow-up: Effectiveness of early intervention with budesonide in mild persistent asthma",
abstract = "Background: The Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START) study enrolled 7241 patients aged 5 to 66 years with recent-onset, mild persistent asthma to assess early intervention with the inhaled corticosteroid budesonide on long-term asthma control. Objective: The open-label phase of the START study was included to determine the effect on lung function and asthma control of adding budesonide to the reference group patients who had not initially received inhaled corticosteroids. Methods: Patients were randomized to double-blind treatment with budesonide, 200 mg (those aged <11 years) or 400 mg once daily, or placebo plus the usual asthma therapy for 3 years, after which all patients received 2 years of open-label treatment with budesonide once daily. Results: During the full 5-year study period, postbronchodilator FEV1 percent predicted decreased, irrespective of randomized treatment during the double-blind phase, by an average of 2.22{\%} (SE, 0.15{\%}). However, patients with inhaled budesonide in the double-blind phase had a significantly lower risk (odds ratio, 0.61; P <.001) of a severe asthma-related event during the full 5-year study period than those in the reference group. Moreover, patients in the reference group used more additional asthma medications during both the open-label and double-blind phases. Conclusions: In mild persistent asthma early intervention with inhaled budesonide was associated with improved asthma control and less additional asthma medication use.",
keywords = "budesonide dry-powder inhaler, inhaled corticosteroid, Mild persistent asthma, recent-onset asthma",
author = "{START Investigators Group} and {START investigators (and numbers of patients recruited) by country} and Busse, {William W.} and S{\o}ren Pedersen and Pauwels, {Romain A.} and Tan, {Wan C.} and Chen, {Yu Zhi} and Lamm, {Carl Johan} and O'Byrne, {Paul M.} and A. Sheffer and A. Woolcock and P. Diaz and M. Silverman and B. Lindmark and Josef Eckmayr and Josef Riedler and Gert Wurzinger and G{\"u}nter Ott and Jasminka Zarkovic and Andrea Schulheim and Manfred G{\"o}tz and Herwig Schinko and Ingrid Thom{\"u}ller and {De Backer}, Wilfried and {Van Bever}, Hugo and Geert Verleden and {De Boeck}, Christiane and Joseph Aumann and Walter Vincken and Isidor Dab and {De Vuyst}, Paul and {De Jonghe}, Marc and Georges Casimir and Guy Joos and {De Baets}, Frans and Yves Bogaerts and Halloy, {Jean Luc} and Pierre Bartsch and Jacques Thiriaux and Petr Pohunek and Ondŕej Rybn{\'i}ćek and Olga ͆kopkov{\'a} and Ludmila Pavelkov{\'a} and Pavel Broź and Eva Ohnutkov{\'a} and Bronislava Novotn{\'a} and Jiŕ{\'i} Baĺy and Irena Krćmov{\'a} and Zuzana Kuralov{\'a} and Tom{\'a}s̈ Koć{\'i} and Helena Honomichlov{\'a} and Kuo, {Han Pin}",
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T1 - The Inhaled Steroid Treatment As Regular Therapy in Early Asthma (START) study 5-year follow-up

T2 - Effectiveness of early intervention with budesonide in mild persistent asthma

AU - START Investigators Group

AU - START investigators (and numbers of patients recruited) by country

AU - Busse, William W.

AU - Pedersen, Søren

AU - Pauwels, Romain A.

AU - Tan, Wan C.

AU - Chen, Yu Zhi

AU - Lamm, Carl Johan

AU - O'Byrne, Paul M.

AU - Sheffer, A.

AU - Woolcock, A.

AU - Diaz, P.

AU - Silverman, M.

AU - Lindmark, B.

AU - Eckmayr, Josef

AU - Riedler, Josef

AU - Wurzinger, Gert

AU - Ott, Günter

AU - Zarkovic, Jasminka

AU - Schulheim, Andrea

AU - Götz, Manfred

AU - Schinko, Herwig

AU - Thomüller, Ingrid

AU - De Backer, Wilfried

AU - Van Bever, Hugo

AU - Verleden, Geert

AU - De Boeck, Christiane

AU - Aumann, Joseph

AU - Vincken, Walter

AU - Dab, Isidor

AU - De Vuyst, Paul

AU - De Jonghe, Marc

AU - Casimir, Georges

AU - Joos, Guy

AU - De Baets, Frans

AU - Bogaerts, Yves

AU - Halloy, Jean Luc

AU - Bartsch, Pierre

AU - Thiriaux, Jacques

AU - Pohunek, Petr

AU - Rybníćek, Ondŕej

AU - ͆kopková, Olga

AU - Pavelková, Ludmila

AU - Broź, Pavel

AU - Ohnutková, Eva

AU - Novotná, Bronislava

AU - Baĺy, Jiŕí

AU - Krćmová, Irena

AU - Kuralová, Zuzana

AU - Koćí, Tomás̈

AU - Honomichlová, Helena

AU - Kuo, Han Pin

PY - 2008/1/1

Y1 - 2008/1/1

N2 - Background: The Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START) study enrolled 7241 patients aged 5 to 66 years with recent-onset, mild persistent asthma to assess early intervention with the inhaled corticosteroid budesonide on long-term asthma control. Objective: The open-label phase of the START study was included to determine the effect on lung function and asthma control of adding budesonide to the reference group patients who had not initially received inhaled corticosteroids. Methods: Patients were randomized to double-blind treatment with budesonide, 200 mg (those aged <11 years) or 400 mg once daily, or placebo plus the usual asthma therapy for 3 years, after which all patients received 2 years of open-label treatment with budesonide once daily. Results: During the full 5-year study period, postbronchodilator FEV1 percent predicted decreased, irrespective of randomized treatment during the double-blind phase, by an average of 2.22% (SE, 0.15%). However, patients with inhaled budesonide in the double-blind phase had a significantly lower risk (odds ratio, 0.61; P <.001) of a severe asthma-related event during the full 5-year study period than those in the reference group. Moreover, patients in the reference group used more additional asthma medications during both the open-label and double-blind phases. Conclusions: In mild persistent asthma early intervention with inhaled budesonide was associated with improved asthma control and less additional asthma medication use.

AB - Background: The Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START) study enrolled 7241 patients aged 5 to 66 years with recent-onset, mild persistent asthma to assess early intervention with the inhaled corticosteroid budesonide on long-term asthma control. Objective: The open-label phase of the START study was included to determine the effect on lung function and asthma control of adding budesonide to the reference group patients who had not initially received inhaled corticosteroids. Methods: Patients were randomized to double-blind treatment with budesonide, 200 mg (those aged <11 years) or 400 mg once daily, or placebo plus the usual asthma therapy for 3 years, after which all patients received 2 years of open-label treatment with budesonide once daily. Results: During the full 5-year study period, postbronchodilator FEV1 percent predicted decreased, irrespective of randomized treatment during the double-blind phase, by an average of 2.22% (SE, 0.15%). However, patients with inhaled budesonide in the double-blind phase had a significantly lower risk (odds ratio, 0.61; P <.001) of a severe asthma-related event during the full 5-year study period than those in the reference group. Moreover, patients in the reference group used more additional asthma medications during both the open-label and double-blind phases. Conclusions: In mild persistent asthma early intervention with inhaled budesonide was associated with improved asthma control and less additional asthma medication use.

KW - budesonide dry-powder inhaler

KW - inhaled corticosteroid

KW - Mild persistent asthma

KW - recent-onset asthma

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U2 - 10.1016/j.jaci.2008.02.029

DO - 10.1016/j.jaci.2008.02.029

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EP - 1174

JO - Journal of Allergy and Clinical Immunology

JF - Journal of Allergy and Clinical Immunology

SN - 0091-6749

IS - 5

ER -