Skip to main content

Main menu

  • Home
  • Current issue
  • ERJ Early View
  • Past issues
  • Authors/reviewers
    • Instructions for authors
    • Submit a manuscript
    • Open access
    • COVID-19 submission information
    • Peer reviewer login
  • Alerts
  • Podcasts
  • Subscriptions
  • ERS Publications
    • European Respiratory Journal
    • ERJ Open Research
    • European Respiratory Review
    • Breathe
    • ERS Books
    • ERS publications home

User menu

  • Log in
  • Subscribe
  • Contact Us
  • My Cart

Search

  • Advanced search
  • ERS Publications
    • European Respiratory Journal
    • ERJ Open Research
    • European Respiratory Review
    • Breathe
    • ERS Books
    • ERS publications home

Login

European Respiratory Society

Advanced Search

  • Home
  • Current issue
  • ERJ Early View
  • Past issues
  • Authors/reviewers
    • Instructions for authors
    • Submit a manuscript
    • Open access
    • COVID-19 submission information
    • Peer reviewer login
  • Alerts
  • Podcasts
  • Subscriptions

Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease

W. Szafranski, A. Cukier, A. Ramirez, G. Menga, R. Sansores, S. Nahabedian, S. Peterson, H. Olsson
European Respiratory Journal 2003 21: 74-81; DOI: 10.1183/09031936.03.00031402
W. Szafranski
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
A. Cukier
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
A. Ramirez
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
G. Menga
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
R. Sansores
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
S. Nahabedian
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
S. Peterson
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
H. Olsson
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • Info & Metrics
  • PDF
Loading

Figures

  • Tables
  • Additional Files
  • Fig. 1.—
    • Download figure
    • Open in new tab
    • Download powerpoint
    Fig. 1.—

    Kaplan-Meier plot of discontinuations, by treatment group. ––: Symbicort; ·····: budesonide; ----: formoterol; –··–: placebo.

  • Fig. 2.—
    • Download figure
    • Open in new tab
    • Download powerpoint
    Fig. 2.—

    Mean values for forced expiratory volume in one second (FEV1) measured at clinic visits. ▪: budesonide/formoterol; ▴: budesonide; ▾: formoterol; ♦: placebo. p<0.001 budesonide/formoterol versus placebo and budesonide; p<0.001 formoterol versus placebo; p<0.05 budesonide versus placebo.

  • Fig. 3.—
    • Download figure
    • Open in new tab
    • Download powerpoint
    Fig. 3.—

    Change in morning peak expiratory flow (PEF) from baseline over 12 months (from daily diary card data). 1: budesonide/formoterol; 2: budesonide; 3: formoterol; 4: placebo. Differences of 16, 12, 24 L·min−1 for budesonide/formoterol versus budesonide, formoterol and placebo, respectively (all p<0.001); budesonide versus placebo 8 L·min−1 (p=0.015); formoterol versus placebo 12 L·min−1 (p<0.001).

  • Fig. 4.—
    • Download figure
    • Open in new tab
    • Download powerpoint
    Fig. 4.—

    Change in evening peak expiratory flow (PEF) from baseline over 12 months (from daily diary card data). 1: budesonide/formoterol; 2: budesonide; 3: formoterol; 4: placebo. Difference of 15, 11, 20 L·min−1 for budesonide/formoterol versus budesonide, formoterol and placebo, respectively (all p<0.001); budesonide versus placebo 5 L·min−1 (p=0.104); formoterol versus placebo 9 L·min−1 (p=0.009).

  • Fig. 5.—
    • Download figure
    • Open in new tab
    • Download powerpoint
    Fig. 5.—

    Improvements in morning peak expiratory flow (PEF) from daily diary card data (day 1 (┘) and week 1 (□)). Day 1: budesonide/formoterol versus budesonide p<0.001, versus formoterol p=0.081. Week 1: budesonide/formoterol versus budesonide p<0.001, versus formoterol p=0.002. *: p<0.05 versus placebo; ***: p<0.001 versus placebo.

Tables

  • Figures
  • Additional Files
  • Table 1

    Patient demographic and baseline characteristics

    Budesonide/formoterolBudesonideFormoterolPlacebo
    Patients n208198201205
    Male %76807683
    Mean age yrs (range)64 (41–82)64 (40–90)63 (40–90)65 (47–92)
    Current smokers %30363834
    Mean pack-yrs44444545
    Previous medication % of patients
     ICS26242826
     Inhaled SABAs67707169
     Anticholinergics24312729
     Inhaled LABAs17171620
     Xanthines26252231
     Inhaled β2‐agonist/anticholinergic25202021
    FEV1 L0.961.011.000.98
    FEV1 % pred36373636
    FEV1/VC %41444342
    Reversibility % pred6565
    • ICS: inhaled corticosteroid

    • SABA: short-acting β2‐agonist

    • LABA: long-acting β2‐agonist

    • FEV1: forced expiratory volume in one second

    • VC: vital capacity

    • % pred: % predicted normal

  • Table 2

    Patient flow

    Budesonide/formoterolBudesonideFormoterolPlaceboTotal
    Patients randomised208198201205812
    Patients discontinued after randomisation#59 (28)***62 (31)*64 (32)*90 (44)275
    Patients discontinued due to COPD deterioration#20 (10)***23 (12)*29 (14)*43 (21)115
    Patients discontinued due to AEs other than COPD deterioration16 (8)13 (7)12 (6)17 (8)58
    Patients completing study149 (72)136 (69)137 (68)115 (56)537
    • Data are presented as n (%) unless otherwise stated

    • *: p<0.05

    • ***: p<0.001 versus placebo

    • #: Cox regression model

  • Table 3

    Statistical analysis of primary variables

    Treatment comparisonsSevere exacerbationsFEV1
    Reduction % (absolute values#)95% CIp‐valueIncrease %95% CIp‐value
    Budesonide/formoterol versus placebo24 (0.758)1.9–41.40.0351511.0–19.1<0.001
    Budesonide/formoterol versus budesonide11 (0.889)−15.9–31.80.38595.4–13.1<0.001
    Budesonide/formoterol versus formoterol23 (0.771)0.8–40.10.0431−2.2–4.90.487
    Budesonide versus placebo15 (0.852)−10.3–34.10.22451.5–9.10.005
    Formoterol versus placebo2 (0.984)−25.7–23.00.895149.5–17.7<0.001
    • FEV1: forced expiratory volume in one second

    • CI: confidence interval

    • #: rate ratios (see Analysis section)

  • Table 4

    Symptom scores for first week of treatment and at 12 months

    Treatment comparisonsTotal symptom score (0–16)Awakening score (0–4)Shortness of breath score (0–4)Cough score (0–4)Chest tightness score (0–4)
    Week 112 monthsWeek 112 monthsWeek 112 monthsWeek 112 monthsWeek 112 months
    Budesonide/−1.21−0.77−0.30−0.34−0.35−0.36−0.28−0.19−0.24−0.21
     formoterol versus placebo(p<0.001)(p<0.001)(p<0.001)(p<0.001)(p<0.001)(p<0.001)(p<0.001)(p=0.002)(p<0.001)(p<0.001)
    Budesonide/−0.80−0.70−0.20−0.20−0.28−0.26−0.15−0.22−0.14−0.13
     formoterol versus budesonide(p<0.001)(p<0.001)(p=0.004)(p=0.003)(p<0.001)(p<0.001)(p=0.022)(p<0.001)(p=0.020)(p=0.043)
    Budesonide/−0.69−0.27−0.20−0.16−0.13−0.11−0.17−0.08−0.12−0.03
     formoterol versus formoterol(p<0.001)(p=0.103)(p=0.005)(p=0.019)(p=0.038)(p=0.107)(p=0.012)(p=0.204)(p=0.047)(p=0.678)
    • Data are presented as score (p‐value)

  • Table 5

    Serious adverse events (SAEs)

    Budesonide/formoterolBudesonideFormoterolPlacebo
    Patients n208198201205
    Deaths n6569
    SAEs other than deaths n43353737
    SAEs per 1000 treatment days n0.80.70.70.9
    Patients with SAEs n (%)46 (22)35 (18)39 (19)42 (20)

Additional Files

  • Figures
  • Tables
  • German translation

    Files in this Data Supplement:

    • German translation
  • Correction

    Correction, published in Eur Respir J 2003; 21: 912.

    Files in this Data Supplement:

    • Correction - Correction, published in Eur Respir J 2003; 21: 912.
PreviousNext
Back to top
View this article with LENS
Vol 21 Issue 1 Table of Contents
  • Table of Contents
  • Index by author
Email

Thank you for your interest in spreading the word on European Respiratory Society .

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease
(Your Name) has sent you a message from European Respiratory Society
(Your Name) thought you would like to see the European Respiratory Society web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Print
Citation Tools
Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease
W. Szafranski, A. Cukier, A. Ramirez, G. Menga, R. Sansores, S. Nahabedian, S. Peterson, H. Olsson
European Respiratory Journal Jan 2003, 21 (1) 74-81; DOI: 10.1183/09031936.03.00031402

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero

Share
Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease
W. Szafranski, A. Cukier, A. Ramirez, G. Menga, R. Sansores, S. Nahabedian, S. Peterson, H. Olsson
European Respiratory Journal Jan 2003, 21 (1) 74-81; DOI: 10.1183/09031936.03.00031402
del.icio.us logo Digg logo Reddit logo Technorati logo Twitter logo CiteULike logo Connotea logo Facebook logo Google logo Mendeley logo
Full Text (PDF)

Jump To

  • Article
    • Abstract
    • Methods
    • Results
    • Discussion
    • Acknowledgments
    • References
  • Figures & Data
  • Info & Metrics
  • PDF
  • Tweet Widget
  • Facebook Like
  • Google Plus One

More in this TOC Section

  • Novel strategy to identify genetic risk factors for COPD severity: a genetic isolate
  • Calculating gambling odds and lung ages for smokers
  • Prevention of panic attacks and panic disorder in COPD
Show more Original Articles: COPD

Related Articles

Navigate

  • Home
  • Current issue
  • Archive

About the ERJ

  • Journal information
  • Editorial board
  • Reviewers
  • Press
  • Permissions and reprints
  • Advertising

The European Respiratory Society

  • Society home
  • myERS
  • Privacy policy
  • Accessibility

ERS publications

  • European Respiratory Journal
  • ERJ Open Research
  • European Respiratory Review
  • Breathe
  • ERS books online
  • ERS Bookshop

Help

  • Feedback

For authors

  • Instructions for authors
  • Publication ethics and malpractice
  • Submit a manuscript

For readers

  • Alerts
  • Subjects
  • Podcasts
  • RSS

Subscriptions

  • Accessing the ERS publications

Contact us

European Respiratory Society
442 Glossop Road
Sheffield S10 2PX
United Kingdom
Tel: +44 114 2672860
Email: journals@ersnet.org

ISSN

Print ISSN:  0903-1936
Online ISSN: 1399-3003

Copyright © 2022 by the European Respiratory Society