Early intervention with budesonide in mild persistent asthma: A randomised, double-blind trial

START Investigators Group, START Investigators

Research output: Contribution to journalArticle

563 Citations (Scopus)

Abstract

Background Although inhaled glucocorticosteroids are recommended for persistent asthma, their long-term effect on recent onset, mild, persistent asthma has yet to be established. Methods We did a randomised, double-blind clinical trial in 7241 patients in 32 countries to assess the effects of budesonide in patients who had had mild persistent asthma for less than 2 years and who had not had previous regular treatment with glucocorticosteroids. Patients aged 5-66 years received either budesonide or placebo once daily for 3 years in addition to their usual asthma medications. The daily budesonide dose was 400 μg, or 200 μg for children younger than 11 years. The primary outcome was time to first severe asthma-related event, and analysis was by intention to treat. Findings 198 of 3568 patients on placebo and 117 of 3597 on budesonide had at least one severe asthma exacerbation; hazard ratio 0.56 (95% CI 0.45-0.71, p<0.0001). Patients on budesonide had fewer courses of systemic corticosteroids and more symptom-free days than did those on placebo. Compared with placebo, budesonide increased postbronchodilator forced expiratory volume in 1 s (FEV1) from baseline by 1.48% (p<0.0001) after 1 year and by 0.88% (p=0.0005) after 3 years (expressed as percent of the predicted value). The corresponding increase in prebronchodilator FEV1 was 2.24% after 1 year and 1.71% after 3 years (p<0.0001 at both timepoints). The effect of treatment on all outcome variables was independent of the baseline lung function (prebronchodilator or postbronchodilator) or baseline medication. In children younger than 11 years, 3-year growth was reduced in the budesonide group by 1.34 cm. The reduction was greatest in the first year of treatment (0.58 cm) than years 2 and 3 (0.43 cm and 0.33 cm, respectively) Interpretation Long-term, once-daily treatment with low-dose budesonide decreases the risk of severe exacerbations and improves asthma control in patients with mild persistent asthma of recent onset.

Original languageEnglish
Pages (from-to)1071-1076
Number of pages6
JournalLancet
Volume361
Issue number9363
DOIs
Publication statusPublished - Mar 29 2003

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Budesonide
Asthma
Placebos
Forced Expiratory Volume
Intention to Treat Analysis
Therapeutics
Adrenal Cortex Hormones
Clinical Trials
Lung
Growth

ASJC Scopus subject areas

  • Medicine(all)

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Early intervention with budesonide in mild persistent asthma : A randomised, double-blind trial. / START Investigators Group; START Investigators.

In: Lancet, Vol. 361, No. 9363, 29.03.2003, p. 1071-1076.

Research output: Contribution to journalArticle

START Investigators Group ; START Investigators. / Early intervention with budesonide in mild persistent asthma : A randomised, double-blind trial. In: Lancet. 2003 ; Vol. 361, No. 9363. pp. 1071-1076.
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abstract = "Background Although inhaled glucocorticosteroids are recommended for persistent asthma, their long-term effect on recent onset, mild, persistent asthma has yet to be established. Methods We did a randomised, double-blind clinical trial in 7241 patients in 32 countries to assess the effects of budesonide in patients who had had mild persistent asthma for less than 2 years and who had not had previous regular treatment with glucocorticosteroids. Patients aged 5-66 years received either budesonide or placebo once daily for 3 years in addition to their usual asthma medications. The daily budesonide dose was 400 μg, or 200 μg for children younger than 11 years. The primary outcome was time to first severe asthma-related event, and analysis was by intention to treat. Findings 198 of 3568 patients on placebo and 117 of 3597 on budesonide had at least one severe asthma exacerbation; hazard ratio 0.56 (95{\%} CI 0.45-0.71, p<0.0001). Patients on budesonide had fewer courses of systemic corticosteroids and more symptom-free days than did those on placebo. Compared with placebo, budesonide increased postbronchodilator forced expiratory volume in 1 s (FEV1) from baseline by 1.48{\%} (p<0.0001) after 1 year and by 0.88{\%} (p=0.0005) after 3 years (expressed as percent of the predicted value). The corresponding increase in prebronchodilator FEV1 was 2.24{\%} after 1 year and 1.71{\%} after 3 years (p<0.0001 at both timepoints). The effect of treatment on all outcome variables was independent of the baseline lung function (prebronchodilator or postbronchodilator) or baseline medication. In children younger than 11 years, 3-year growth was reduced in the budesonide group by 1.34 cm. The reduction was greatest in the first year of treatment (0.58 cm) than years 2 and 3 (0.43 cm and 0.33 cm, respectively) Interpretation Long-term, once-daily treatment with low-dose budesonide decreases the risk of severe exacerbations and improves asthma control in patients with mild persistent asthma of recent onset.",
author = "{START Investigators Group} and {START Investigators} and Pauwels, {Romain A.} and S{\o}ren Pedersen and Busse, {William W.} and Tan, {Wan C.} and Chen, {Yu Zhi} and Ohlsson, {Stefan V.} and Anders Ullman 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 Kuo, {Han Pin}",
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TY - JOUR

T1 - Early intervention with budesonide in mild persistent asthma

T2 - A randomised, double-blind trial

AU - START Investigators Group

AU - START Investigators

AU - Pauwels, Romain A.

AU - Pedersen, Søren

AU - Busse, William W.

AU - Tan, Wan C.

AU - Chen, Yu Zhi

AU - Ohlsson, Stefan V.

AU - Ullman, Anders

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 - Kuo, Han Pin

PY - 2003/3/29

Y1 - 2003/3/29

N2 - Background Although inhaled glucocorticosteroids are recommended for persistent asthma, their long-term effect on recent onset, mild, persistent asthma has yet to be established. Methods We did a randomised, double-blind clinical trial in 7241 patients in 32 countries to assess the effects of budesonide in patients who had had mild persistent asthma for less than 2 years and who had not had previous regular treatment with glucocorticosteroids. Patients aged 5-66 years received either budesonide or placebo once daily for 3 years in addition to their usual asthma medications. The daily budesonide dose was 400 μg, or 200 μg for children younger than 11 years. The primary outcome was time to first severe asthma-related event, and analysis was by intention to treat. Findings 198 of 3568 patients on placebo and 117 of 3597 on budesonide had at least one severe asthma exacerbation; hazard ratio 0.56 (95% CI 0.45-0.71, p<0.0001). Patients on budesonide had fewer courses of systemic corticosteroids and more symptom-free days than did those on placebo. Compared with placebo, budesonide increased postbronchodilator forced expiratory volume in 1 s (FEV1) from baseline by 1.48% (p<0.0001) after 1 year and by 0.88% (p=0.0005) after 3 years (expressed as percent of the predicted value). The corresponding increase in prebronchodilator FEV1 was 2.24% after 1 year and 1.71% after 3 years (p<0.0001 at both timepoints). The effect of treatment on all outcome variables was independent of the baseline lung function (prebronchodilator or postbronchodilator) or baseline medication. In children younger than 11 years, 3-year growth was reduced in the budesonide group by 1.34 cm. The reduction was greatest in the first year of treatment (0.58 cm) than years 2 and 3 (0.43 cm and 0.33 cm, respectively) Interpretation Long-term, once-daily treatment with low-dose budesonide decreases the risk of severe exacerbations and improves asthma control in patients with mild persistent asthma of recent onset.

AB - Background Although inhaled glucocorticosteroids are recommended for persistent asthma, their long-term effect on recent onset, mild, persistent asthma has yet to be established. Methods We did a randomised, double-blind clinical trial in 7241 patients in 32 countries to assess the effects of budesonide in patients who had had mild persistent asthma for less than 2 years and who had not had previous regular treatment with glucocorticosteroids. Patients aged 5-66 years received either budesonide or placebo once daily for 3 years in addition to their usual asthma medications. The daily budesonide dose was 400 μg, or 200 μg for children younger than 11 years. The primary outcome was time to first severe asthma-related event, and analysis was by intention to treat. Findings 198 of 3568 patients on placebo and 117 of 3597 on budesonide had at least one severe asthma exacerbation; hazard ratio 0.56 (95% CI 0.45-0.71, p<0.0001). Patients on budesonide had fewer courses of systemic corticosteroids and more symptom-free days than did those on placebo. Compared with placebo, budesonide increased postbronchodilator forced expiratory volume in 1 s (FEV1) from baseline by 1.48% (p<0.0001) after 1 year and by 0.88% (p=0.0005) after 3 years (expressed as percent of the predicted value). The corresponding increase in prebronchodilator FEV1 was 2.24% after 1 year and 1.71% after 3 years (p<0.0001 at both timepoints). The effect of treatment on all outcome variables was independent of the baseline lung function (prebronchodilator or postbronchodilator) or baseline medication. In children younger than 11 years, 3-year growth was reduced in the budesonide group by 1.34 cm. The reduction was greatest in the first year of treatment (0.58 cm) than years 2 and 3 (0.43 cm and 0.33 cm, respectively) Interpretation Long-term, once-daily treatment with low-dose budesonide decreases the risk of severe exacerbations and improves asthma control in patients with mild persistent asthma of recent onset.

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