Adjustable maintenance dosing with budesonide/formoterol reduces asthma exacerbations compared with traditional fixed dosing: A five-month multicentre Canadian study

J. Mark FitzGerald; Malcolm R. Sears; Louise Philippe Boulet; Allan B. Becker; Andrew R. McIvor; Pierre Ernst; Natasha M. Smiljanic-Georgijev; Joanna S.M. Lee; R. Abdulla; G. Achyuthan; E. Amer; J. Anthony; A. Bailey; M. Baltzan; P. Begin; C. Bergstrom; G. Bishop; W. Booth; E. Brankston; R. Brownoff; M. Bukowskyj; D. Carom; E. Carrim; D. J. Carswell; A. Cartier; C. K.N. Chan; C. Che; W. Chow; A. Dhar; G. D'Ignazio; L. Dionne; C. Domingue; A. Dowell; C. Ellis; A. Faiers; D. Fay; T. A. Fera; F. Fraser; M. Gagnon; R. Hart; D. Henry; A. Hirsch; L. A. Homik; P. A. Houle; W. P. House; J. Jadd; F. F. Jardin; S. Kanani; D. S. Kanawaty; A. Kaplan; S. Kapur; A. Kelly; P. Kelton; J. Kim; J. Kozak; P. Kugler; M. LaFreniere; P. Larivee; C. Laroche; B. Lasko; M. Laviolette; M. Leclair; A. Leung; W. Leung; J. Lewis; F. L. Liu; K. R. Loader; J. MacDonald; D. Marciniuk; G. Mazza; W. McLaughlin; S. Mintz; E. Papp; P. C. Patel; K. B. Payton; N. Pinsky; P. Prevost; A. Redekopp; K. Saunders; R. Senior; I. Siegel; D. Sinclair; D. Small; M. Soowamber; K. Stakiw; D. Stollery; C. St-Pierre; G. Taylor; G. Tellier; R. Tytus; W. Winzer; H. Zackon; P. Ziter; P. Zuberbuhler; Gloria Jordana; Paula Dakin; Sophia Calmels; Tony Kim

doi:10.1155/2003/298039

Adjustable maintenance dosing with budesonide/formoterol reduces asthma exacerbations compared with traditional fixed dosing: A five-month multicentre Canadian study

J. Mark FitzGerald, Malcolm R. Sears, Louise Philippe Boulet, Allan B. Becker, Andrew R. McIvor, Pierre Ernst, Natasha M. Smiljanic-Georgijev, Joanna S.M. Lee, R. Abdulla, G. Achyuthan, E. Amer, J. Anthony, A. Bailey, M. Baltzan, P. Begin, C. Bergstrom, G. Bishop, W. Booth, E. Brankston, R. BrownoffM. Bukowskyj, D. Carom, E. Carrim, D. J. Carswell, A. Cartier, C. K.N. Chan, C. Che, W. Chow, A. Dhar, G. D'Ignazio, L. Dionne, C. Domingue, A. Dowell, C. Ellis, A. Faiers, D. Fay, T. A. Fera, F. Fraser, M. Gagnon, R. Hart, D. Henry, A. Hirsch, L. A. Homik, P. A. Houle, W. P. House, J. Jadd, F. F. Jardin, S. Kanani, D. S. Kanawaty, A. Kaplan, S. Kapur, A. Kelly, P. Kelton, J. Kim, J. Kozak, P. Kugler, M. LaFreniere, P. Larivee, C. Laroche, B. Lasko, M. Laviolette, M. Leclair, A. Leung, W. Leung, J. Lewis, F. L. Liu, K. R. Loader, J. MacDonald, D. Marciniuk, G. Mazza, W. McLaughlin, S. Mintz, E. Papp, P. C. Patel, K. B. Payton, N. Pinsky, P. Prevost, A. Redekopp, K. Saunders, R. Senior, I. Siegel, D. Sinclair, D. Small, M. Soowamber, K. Stakiw, D. Stollery, C. St-Pierre, G. Taylor, G. Tellier, R. Tytus, W. Winzer, H. Zackon, P. Ziter, P. Zuberbuhler, Gloria Jordana, Paula Dakin, Sophia Calmels, Tony Kim

Medicine

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Résumé

Background: Adjustable maintenance dosing with budesonide/formoterol in a single inhaler (Symbicort, AstraZeneca, Lund, Sweden) may provide a convenient means of maintaining asthma control with the minimum effective medication level. Objectives: To compare adjustable and fixed maintenance dosing regimens of budesonide/formoterol in asthma. Methods: This was an open-label, randomized, parallel-group, multicentre, Canadian study of asthma patients (aged 12 years or older, postbronchodilator forced expiratory volume in 1 s 70% or greater of predicted normal). Following a one-month run-in on budesonide/formoterol (100/6 μg or 200/6 μg metered doses, two inhalations twice daily), 995 patients were randomly assigned either to continue on this fixed dosing regimen or to receive budesonide/formoterol adjustable dosing (step down to one inhalation twice daily if symptoms were controlled or temporarily step up to four inhalations twice daily for seven or 14 days if asthma worsened). The primary efficacy variable was the occurrence of exacerbations (requiring oral or inhaled corticosteroids, emergency department treatment, serious adverse events or added maintenance therapy because of asthma). Results: With adjustable dosing, significantly fewer patients experienced exacerbations compared with fixed dosing (4.0% versus 8.9%, P=0.002; number needed to treat=21 [95% CI 13 to 591). Patients required 36% fewer overall doses of budesonide/formoterol (2.5 versus 3.9 inhalations/day, P<0.001), and total costs per patient were lower (difference over five months CDN$-141 [95% CI -$162 to -$116]). Asthma symptom severity (modified National Heart, Lung, and Blood Institute stage) was maintained or improved in 97% or greater of patients in both groups (pre-run-in to end of treatment). Both treatments were well tolerated. Conclusions: Budesonide/formoterol adjustable maintenance dosing provided more effective asthma control than fixed dosing, with a lower overall drug dose and reduced total cost.

Langue d'origine	English
Pages (de-à)	427-434
Nombre de pages	8
Journal	Canadian Respiratory Journal
Volume	10
Numéro de publication	8
DOI	https://doi.org/10.1155/2003/298039
Statut de publication	Published - 2003

ASJC Scopus Subject Areas

Pulmonary and Respiratory Medicine

PubMed: MeSH publication types

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

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10.1155/2003/298039

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FitzGerald, J. M., Sears, M. R., Boulet, L. P., Becker, A. B., McIvor, A. R., Ernst, P., Smiljanic-Georgijev, N. M., Lee, J. S. M., Abdulla, R., Achyuthan, G., Amer, E., Anthony, J., Bailey, A., Baltzan, M., Begin, P., Bergstrom, C., Bishop, G., Booth, W., Brankston, E., ... Kim, T. (2003). Adjustable maintenance dosing with budesonide/formoterol reduces asthma exacerbations compared with traditional fixed dosing: A five-month multicentre Canadian study. Canadian Respiratory Journal, 10(8), 427-434. https://doi.org/10.1155/2003/298039

FitzGerald, JM, Sears, MR, Boulet, LP, Becker, AB, McIvor, AR, Ernst, P, Smiljanic-Georgijev, NM, Lee, JSM, Abdulla, R, Achyuthan, G, Amer, E, Anthony, J, Bailey, A, Baltzan, M, Begin, P, Bergstrom, C, Bishop, G, Booth, W, Brankston, E, Brownoff, R, Bukowskyj, M, Carom, D, Carrim, E, Carswell, DJ, Cartier, A, Chan, CKN, Che, C, Chow, W, Dhar, A, D'Ignazio, G, Dionne, L, Domingue, C, Dowell, A, Ellis, C, Faiers, A, Fay, D, Fera, TA, Fraser, F, Gagnon, M, Hart, R, Henry, D, Hirsch, A, Homik, LA, Houle, PA, House, WP, Jadd, J, Jardin, FF, Kanani, S, Kanawaty, DS, Kaplan, A, Kapur, S, Kelly, A, Kelton, P, Kim, J, Kozak, J, Kugler, P, LaFreniere, M, Larivee, P, Laroche, C, Lasko, B, Laviolette, M, Leclair, M, Leung, A, Leung, W, Lewis, J, Liu, FL, Loader, KR, MacDonald, J, Marciniuk, D, Mazza, G, McLaughlin, W, Mintz, S, Papp, E, Patel, PC, Payton, KB, Pinsky, N, Prevost, P, Redekopp, A, Saunders, K, Senior, R, Siegel, I, Sinclair, D, Small, D, Soowamber, M, Stakiw, K, Stollery, D, St-Pierre, C, Taylor, G, Tellier, G, Tytus, R, Winzer, W, Zackon, H, Ziter, P, Zuberbuhler, P, Jordana, G, Dakin, P, Calmels, S & Kim, T 2003, 'Adjustable maintenance dosing with budesonide/formoterol reduces asthma exacerbations compared with traditional fixed dosing: A five-month multicentre Canadian study', Canadian Respiratory Journal, vol. 10, n° 8, pp. 427-434. https://doi.org/10.1155/2003/298039

@article{893c647d3d084c98871be4b340e100d1,

title = "Adjustable maintenance dosing with budesonide/formoterol reduces asthma exacerbations compared with traditional fixed dosing: A five-month multicentre Canadian study",

abstract = "Background: Adjustable maintenance dosing with budesonide/formoterol in a single inhaler (Symbicort, AstraZeneca, Lund, Sweden) may provide a convenient means of maintaining asthma control with the minimum effective medication level. Objectives: To compare adjustable and fixed maintenance dosing regimens of budesonide/formoterol in asthma. Methods: This was an open-label, randomized, parallel-group, multicentre, Canadian study of asthma patients (aged 12 years or older, postbronchodilator forced expiratory volume in 1 s 70% or greater of predicted normal). Following a one-month run-in on budesonide/formoterol (100/6 μg or 200/6 μg metered doses, two inhalations twice daily), 995 patients were randomly assigned either to continue on this fixed dosing regimen or to receive budesonide/formoterol adjustable dosing (step down to one inhalation twice daily if symptoms were controlled or temporarily step up to four inhalations twice daily for seven or 14 days if asthma worsened). The primary efficacy variable was the occurrence of exacerbations (requiring oral or inhaled corticosteroids, emergency department treatment, serious adverse events or added maintenance therapy because of asthma). Results: With adjustable dosing, significantly fewer patients experienced exacerbations compared with fixed dosing (4.0% versus 8.9%, P=0.002; number needed to treat=21 [95% CI 13 to 591). Patients required 36% fewer overall doses of budesonide/formoterol (2.5 versus 3.9 inhalations/day, P<0.001), and total costs per patient were lower (difference over five months CDN$-141 [95% CI -$162 to -$116]). Asthma symptom severity (modified National Heart, Lung, and Blood Institute stage) was maintained or improved in 97% or greater of patients in both groups (pre-run-in to end of treatment). Both treatments were well tolerated. Conclusions: Budesonide/formoterol adjustable maintenance dosing provided more effective asthma control than fixed dosing, with a lower overall drug dose and reduced total cost.",

author = "FitzGerald, {J. Mark} and Sears, {Malcolm R.} and Boulet, {Louise Philippe} and Becker, {Allan B.} and McIvor, {Andrew R.} and Pierre Ernst and Smiljanic-Georgijev, {Natasha M.} and Lee, {Joanna S.M.} and R. Abdulla and G. Achyuthan and E. Amer and J. Anthony and A. Bailey and M. Baltzan and P. Begin and C. Bergstrom and G. Bishop and W. Booth and E. Brankston and R. Brownoff and M. Bukowskyj and D. Carom and E. Carrim and Carswell, {D. J.} and A. Cartier and Chan, {C. K.N.} and C. Che and W. Chow and A. Dhar and G. D'Ignazio and L. Dionne and C. Domingue and A. Dowell and C. Ellis and A. Faiers and D. Fay and Fera, {T. A.} and F. Fraser and M. Gagnon and R. Hart and D. Henry and A. Hirsch and Homik, {L. A.} and Houle, {P. A.} and House, {W. P.} and J. Jadd and Jardin, {F. F.} and S. Kanani and Kanawaty, {D. S.} and A. Kaplan and S. Kapur and A. Kelly and P. Kelton and J. Kim and J. Kozak and P. Kugler and M. LaFreniere and P. Larivee and C. Laroche and B. Lasko and M. Laviolette and M. Leclair and A. Leung and W. Leung and J. Lewis and Liu, {F. L.} and Loader, {K. R.} and J. MacDonald and D. Marciniuk and G. Mazza and W. McLaughlin and S. Mintz and E. Papp and Patel, {P. C.} and Payton, {K. B.} and N. Pinsky and P. Prevost and A. Redekopp and K. Saunders and R. Senior and I. Siegel and D. Sinclair and D. Small and M. Soowamber and K. Stakiw and D. Stollery and C. St-Pierre and G. Taylor and G. Tellier and R. Tytus and W. Winzer and H. Zackon and P. Ziter and P. Zuberbuhler and Gloria Jordana and Paula Dakin and Sophia Calmels and Tony Kim",

year = "2003",

doi = "10.1155/2003/298039",

language = "English",

volume = "10",

pages = "427--434",

journal = "Canadian Respiratory Journal",

issn = "1198-2241",

publisher = "Pulsus Group Inc.",

number = "8",

}

TY - JOUR

T1 - Adjustable maintenance dosing with budesonide/formoterol reduces asthma exacerbations compared with traditional fixed dosing

T2 - A five-month multicentre Canadian study

AU - FitzGerald, J. Mark

AU - Sears, Malcolm R.

AU - Boulet, Louise Philippe

AU - Becker, Allan B.

AU - McIvor, Andrew R.

AU - Ernst, Pierre

AU - Smiljanic-Georgijev, Natasha M.

AU - Lee, Joanna S.M.

AU - Abdulla, R.

AU - Achyuthan, G.

AU - Amer, E.

AU - Anthony, J.

AU - Bailey, A.

AU - Baltzan, M.

AU - Begin, P.

AU - Bergstrom, C.

AU - Bishop, G.

AU - Booth, W.

AU - Brankston, E.

AU - Brownoff, R.

AU - Bukowskyj, M.

AU - Carom, D.

AU - Carrim, E.

AU - Carswell, D. J.

AU - Cartier, A.

AU - Chan, C. K.N.

AU - Che, C.

AU - Chow, W.

AU - Dhar, A.

AU - D'Ignazio, G.

AU - Dionne, L.

AU - Domingue, C.

AU - Dowell, A.

AU - Ellis, C.

AU - Faiers, A.

AU - Fay, D.

AU - Fera, T. A.

AU - Fraser, F.

AU - Gagnon, M.

AU - Hart, R.

AU - Henry, D.

AU - Hirsch, A.

AU - Homik, L. A.

AU - Houle, P. A.

AU - House, W. P.

AU - Jadd, J.

AU - Jardin, F. F.

AU - Kanani, S.

AU - Kanawaty, D. S.

AU - Kaplan, A.

AU - Kapur, S.

AU - Kelly, A.

AU - Kelton, P.

AU - Kim, J.

AU - Kozak, J.

AU - Kugler, P.

AU - LaFreniere, M.

AU - Larivee, P.

AU - Laroche, C.

AU - Lasko, B.

AU - Laviolette, M.

AU - Leclair, M.

AU - Leung, A.

AU - Leung, W.

AU - Lewis, J.

AU - Liu, F. L.

AU - Loader, K. R.

AU - MacDonald, J.

AU - Marciniuk, D.

AU - Mazza, G.

AU - McLaughlin, W.

AU - Mintz, S.

AU - Papp, E.

AU - Patel, P. C.

AU - Payton, K. B.

AU - Pinsky, N.

AU - Prevost, P.

AU - Redekopp, A.

AU - Saunders, K.

AU - Senior, R.

AU - Siegel, I.

AU - Sinclair, D.

AU - Small, D.

AU - Soowamber, M.

AU - Stakiw, K.

AU - Stollery, D.

AU - St-Pierre, C.

AU - Taylor, G.

AU - Tellier, G.

AU - Tytus, R.

AU - Winzer, W.

AU - Zackon, H.

AU - Ziter, P.

AU - Zuberbuhler, P.

AU - Jordana, Gloria

AU - Dakin, Paula

AU - Calmels, Sophia

AU - Kim, Tony

PY - 2003

Y1 - 2003

N2 - Background: Adjustable maintenance dosing with budesonide/formoterol in a single inhaler (Symbicort, AstraZeneca, Lund, Sweden) may provide a convenient means of maintaining asthma control with the minimum effective medication level. Objectives: To compare adjustable and fixed maintenance dosing regimens of budesonide/formoterol in asthma. Methods: This was an open-label, randomized, parallel-group, multicentre, Canadian study of asthma patients (aged 12 years or older, postbronchodilator forced expiratory volume in 1 s 70% or greater of predicted normal). Following a one-month run-in on budesonide/formoterol (100/6 μg or 200/6 μg metered doses, two inhalations twice daily), 995 patients were randomly assigned either to continue on this fixed dosing regimen or to receive budesonide/formoterol adjustable dosing (step down to one inhalation twice daily if symptoms were controlled or temporarily step up to four inhalations twice daily for seven or 14 days if asthma worsened). The primary efficacy variable was the occurrence of exacerbations (requiring oral or inhaled corticosteroids, emergency department treatment, serious adverse events or added maintenance therapy because of asthma). Results: With adjustable dosing, significantly fewer patients experienced exacerbations compared with fixed dosing (4.0% versus 8.9%, P=0.002; number needed to treat=21 [95% CI 13 to 591). Patients required 36% fewer overall doses of budesonide/formoterol (2.5 versus 3.9 inhalations/day, P<0.001), and total costs per patient were lower (difference over five months CDN$-141 [95% CI -$162 to -$116]). Asthma symptom severity (modified National Heart, Lung, and Blood Institute stage) was maintained or improved in 97% or greater of patients in both groups (pre-run-in to end of treatment). Both treatments were well tolerated. Conclusions: Budesonide/formoterol adjustable maintenance dosing provided more effective asthma control than fixed dosing, with a lower overall drug dose and reduced total cost.

AB - Background: Adjustable maintenance dosing with budesonide/formoterol in a single inhaler (Symbicort, AstraZeneca, Lund, Sweden) may provide a convenient means of maintaining asthma control with the minimum effective medication level. Objectives: To compare adjustable and fixed maintenance dosing regimens of budesonide/formoterol in asthma. Methods: This was an open-label, randomized, parallel-group, multicentre, Canadian study of asthma patients (aged 12 years or older, postbronchodilator forced expiratory volume in 1 s 70% or greater of predicted normal). Following a one-month run-in on budesonide/formoterol (100/6 μg or 200/6 μg metered doses, two inhalations twice daily), 995 patients were randomly assigned either to continue on this fixed dosing regimen or to receive budesonide/formoterol adjustable dosing (step down to one inhalation twice daily if symptoms were controlled or temporarily step up to four inhalations twice daily for seven or 14 days if asthma worsened). The primary efficacy variable was the occurrence of exacerbations (requiring oral or inhaled corticosteroids, emergency department treatment, serious adverse events or added maintenance therapy because of asthma). Results: With adjustable dosing, significantly fewer patients experienced exacerbations compared with fixed dosing (4.0% versus 8.9%, P=0.002; number needed to treat=21 [95% CI 13 to 591). Patients required 36% fewer overall doses of budesonide/formoterol (2.5 versus 3.9 inhalations/day, P<0.001), and total costs per patient were lower (difference over five months CDN$-141 [95% CI -$162 to -$116]). Asthma symptom severity (modified National Heart, Lung, and Blood Institute stage) was maintained or improved in 97% or greater of patients in both groups (pre-run-in to end of treatment). Both treatments were well tolerated. Conclusions: Budesonide/formoterol adjustable maintenance dosing provided more effective asthma control than fixed dosing, with a lower overall drug dose and reduced total cost.

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U2 - 10.1155/2003/298039

DO - 10.1155/2003/298039

M3 - Article

C2 - 14679407

AN - SCOPUS:10744229972

SN - 1198-2241

VL - 10

SP - 427

EP - 434

JO - Canadian Respiratory Journal

JF - Canadian Respiratory Journal

IS - 8

ER -

Adjustable maintenance dosing with budesonide/formoterol reduces asthma exacerbations compared with traditional fixed dosing: A five-month multicentre Canadian study

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