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Lancet. 2003 Mar 29;361(9363):1071-6.

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

Collaborators (495)

Sheffer A, Woolcock A, Diaz P, Silverman M, Lindmark B, Eckmayr J, Riedler J, Wurzinger G, Ott G, Zarkovic J, Schulheim A, Götz M, Schinko H, Thomüller I, de Backer W, van Bever H, Verleden G, de Boeck C, Aumann J, Vincken W, Dab I, de Vuyst P, Jonghe Md, Casimir G, Joos G, de Baets F, Bogaerts Y, Halloy JL, Bartsch P, Casimir G, Thiriaux J, Pohunek P, Rybniŏek O, Skopková O, Pavelková L, Broz P, Ohnutková E, Novotná B, Balý J, Krcmová I, Kuralová Z, Koci T, Honomichlová H, Kasák V, Panzner P, Vondra V, Nĕmecková J, Seberová E, Sỳkora T, Petrů V, Turziková J, Sörensen T, Neldam S, Kludt JP, Hansen UB, Knudsen T, Schultz PJ, Rost D, Jensen F, Kinnula V, Saarelainen P, Eho-Remes M, Valovirta E, Venho KK, Kokko E, Järvinen M, Toljamo T, Taivainen A, Kava T, Herrala J, Kuusela AL, Nordgren P, Syvänen P, Godard P, Rufin P, Anton M, Aubert JP, Grosclaude M, Brambilla C, Archaud P, Racineux JL, Muir JF, Albertini M, Le Roux P, Simmons A, Bartuschka B, Von Berg A, Bergmann V, Bems J, Bisping-Arnold A, Blum HC, Garanin G, Brückner OJ, Burbach P, Sudhoff H, Feldmann M, Schmoller T, Wozny HW, Galaske R, Huptas M, Kaecke J, Köcher V, Laule-Peschel M, Lohr E, Goldberg J, Drescher T, Reeh W, Rabe U, Rehn L, Scheffler NK, Steinmetz KO, Stutz PM, Weber HH, Uhde C, Ullner R, Vehar H, Zarkovic J, Krohn EU, Orosz M, Devai A, Uhereczky G, Rajkay K, Gönczi F, Györi E, Dobra G, Puha K, Sztancsik Z, Gömöri K, Dolinay T, Bittera I, Palinkasi S, Cseke Z, Bisits M, Bjämer D, Holme JI, Langhammer A, Hunstad K, Holmboe JH, Grangård E, Solberg DA, Grönneröd TA, Salkowitsch MB, Oymar K, Iversen K, Szczeklik A, Chyrek-Borowska S, Mincewicz G, Malaczynska T, Latos T, Obtulowicz K, Emeryk A, Gorski P, Nowak D, Szmidt M, Alkiewicz J, Ziolo G, Spychalski L, Chmielewska-Szewcyk D, Nowacka K, Pirozynski M, Prokurat H, Boznanski A, Malolepszy J, Rogala E, Kozielski J, Eriksson UL, Wahlestedt H, Selberg M, Larsson R, Rignér K, Alm B, Aronsson M, Winnergård I, Lagerwall M, Martinsons U, Berlin L, Rydberg B, Weston D, Johnson ME, Barrett C, Siafakas N, Mantzourani E, Orphanidou D, Trakopoulos G, Tzannes S, Kotsovoulou V, Dimadi M, Amfilochiou A, Priftis K, Papageorgiou-Saxoni F, Christaki P, Tsankas I, Paraskevi M, Bousmoukilia S, Spiropoulos K, Anthrakopoulos M, Roussos C, Alkouby LB, Heimer D, Tal A, Horowitz I, Soferman R, Katz Y, Stav D, Weiler Z, Bibi H, Rottem M, Mandelberg A, Geller C, Roizin H, Weiler-Ravell D, Kramer MR, Schwartz Y, Rossi A, Foresi A, Giuntini C, Bisetti A, Scoditti S, Tranfa C, Zacchello F, Giovannini M, Boner A, del Giudice MM, Fabbri LM, Girbino G, Barberio G, Cacciari E, Montefort S, Parascandalo R, Pato R, de Lourdes Chieira M, Moreira C, Santos Chieira D, Brito U, Drummond Borges F, Carvalho Marques A, Manuel Figueiredo M, Dias F, Bugalho de Almeida A, Cesar-Ramos J, Valente MJ, Dias Pereira J, Nunes C, Riberio MF, Marques A, Queiros Rebelo Carvalho M, Vaz de Azvedo M, Ramalho de Almeida A, Figueiredo Pinto JA, Moia Praca Matos Mde F, Afonso A, Lopes Dos Santos J, Fernandez CV, Cienfuegos Agustin I, Lobos Bejarano JM, Abon Santos A, Torrellas Font E, Hernandez Huet E, Lopez Lorente T, Mas Pujol M, Pena Munroz A, Simonet Aineto P, Bardagi Forns S, Benavent I Areu J, Casan P, Ignacio Garcia JM, Valencia Rodriquez A, Sanchez Segura PA, Sánchez Gil R, Pellicer Ciscar C, Ferraro Garcia J, Vegas Jimenez T, Sanchez Gonzalez JI, Quirce Andres F, Amoros Bueno T, Onrubia Baticon C, Ruiz Miguel C, Duce Garcia F, Verea Hernando H, Lopez Vina A, Matia RA, Serrano Cumplido A, Martinez Andueza MC, Serradell Cabra M, Cabrera Navarro PL, Alvarez Rodriguez F, Li JH, Landry D, O'Keefe D, Muram BF, Conter HS, Tweel D, Peters SD, Adelglass J, Baker JW, Berger WE, Bernstein DI, Vick Blake K, Amelong P, Casale TB, Charous BL, Chervinsky P, Condemi JJ, Cook D, Creticos PS, de Graff AC Jr, Smith T, Ellis MH, Grossman J, Halverson PC, Galant S, Hollingsworth H, Jackson C, Jacobs RL, Welch M, Kraemer MJ, Leflein J, Lemanske RF, Liebhaber MI, Lockey R, Kelly B, Mendelson L, Nayak A, Pearlman DS, Ruff M, Schwarz B, Scott MB, Shapiro GG, Silk HJ, Skoner DP, Stoloff S, Swamy KN, Atkins FM, Szefler SJ, Vandewalker M, Wald J, Weinstein SF, Wong DA, Wu F, Goldstein S, Murthy KC, Dolmann A, Gene R, Figueroa Casas JC, Piovano C, Segal E, Balanzat AM, Taborda J, Truganti A, Teper A, Garrood J, Patel MJ, Hogan C, Russel G, Zhu YJ, Cao L, Liu SY, Miao JZ, Ding DJ, Yao WZ, Liu YN, Chen P, Kong SQ, Pang L, Sun B, Zhong ML, Li GS, Chen PL, Zhu Q, Zhang TX, Wang XH, Wei S, Deng WW, Zhou X, Ji YY, Luo WT, Li Q, Zhu HR, Sheng JY, Ma JY, Zhang DP, Ji CZ, Xia XR, Zhang ZY, Yin KS, Yiang J, Li Y, Tang PW, Liu FG, Wang HP, Zhong NS, Rong ZS, Tang YC, Lin CY, Liu JS, Liu HZ, Cai DM, Yang JC, Ma QF, Mangunnegoro H, Wijono CA, Tobing NH, Rahajoe NN, Sugito ES, Hisyam B, Alsagaff H, Santosa G, Kim YY, Park CS, Kim MK, Cho YJ, Choi DC, Jee YK, Mohan J, Yogeswery S, Wong SL, Kuan GL, Koh CT, Quah BS, de Bruyne J, Liam CK, Mejia Avila M, Cuevas F, Chavaje N, Mendoza Topete LA, Badilo I, Ponce M, Chan Merida J, Gonzalez Espinosa A, Ledezma JM, Galindo Garcia JA, Gonzalez Morales G, Montelongo Gomez J, Mendoza Martinez FJ, Reyes Ramos JE, Rodriguez Dorantes J, Canseco Gonzalez C, Gomez Vera J, Bayardo RG, Melendez AP, Loyola CB, Cruz Suárez MA, de Guia T, Balgos A, Bautista N, Realiza T, Diaz D, Yu C, Mendoza-Wi JA, Juaneza R, Bigornia R, Mansukhani P, Cacanindin DN, Wah LB, Hon YK, Yau OY, Moh CO, Tang WY, Dippenaar YD, Kirsten DL, Maraschin EF, Ossip MS, Visser SS, Mouton WL, Mercer M, Cassim KM, Macleod AH, Bateman ED, Leaver R, Morison A, Nel H, Eckart von Delft KH, Vermeulen JH, Weinberg EG, Lund RJ, Weber HC, Kuo SH, Kuo HP, Wang JL, Hsiue TR, Wang JH, Ching CD, Vangveeravong M, Pothiratana C, Trakultivakorn M, Kongpanichkul A, Thamanvat B, Fuangtong R, Suntornlohanakul S, Youngchiyud P, Teeratakulpisarn J, Boonsawat W, Viriyachaiyo V, Direkwattanachai C, Visitsunthorn N.

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 microg, or 200 microg 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.

PMID:
12672309
DOI:
10.1016/S0140-6736(03)12891-7
[Indexed for MEDLINE]

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