COPD: prednisone decreased treatment failure.

Clinical bottom line (level 1b)

  1. Patients given prednisone were less likely to have treatment failure than those given placebo (NNT = 2 at 10 days) .
  2. Patients with an acute exacerbation of COPD who were given prednisone, may be more likely to have greater improvements in PaO 2 and FEV 1 than those given placebo.
Thompson et al: American Journal of Critical Care Medicine 1996; 154: 407-412
Expires November 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: medical centre, USA

27 patients (aged mean 68 years, 96% male) History of cigarette smoking ( = 20 pack-years) and airflow obstruction, and a clinical diagnosis of chronic bronchitis or emphysema as defined by the American Thoracic Society and an acute exacerbation (subjective worsening of chronic baseline dyspnoea or cough for >24 hours and necessitating a hospital visit. Patients were required to have an increase in use of inhaled ß -adrenoceptor agonist for >24 hours, an increase in sputum production and/or purulence.

Excluded if
  • family history of asthma or personal history of asthma, atopy, allergic rhinitis or nasal polyposis
  • history of pulmonary disease other than COPD
  • positive skin test to one or more of a panel of common environmental allergens (cat, dog or horse epithelium, mixed Aspergillus or five grass mix antigens)
  • systemic corticosteroids within 1 month prior to exacerbation
  • uncompensated congestive heart failure
  • fever = 38.5 ° C
  • pneumonia
  • acidaemia (arterial pH <7.35)
  • hospital admission for any reason
  • inability to return for follow-up appointments


    • Control Group: (n = 14, 14 analysed): 9 day course of placebo (vitamin B 6
    Experimental Group: (n = 13, 13 analysed): 9 day course of prednisone in a tapering dose of 60 mg for 3 days, 40 mg for 3 days and 20 mg for 3 days
    Patients were told to increase their ß -adrenoceptor agonist dose to four puffs of the metered-dose inhaler every 4 hours or to take a single nebulised dose every 4 hours. Ipratropium, corticosteroids and theophylline were continued unaltered if taken chronically.
    100% followed for 10 days
    Outcome notes:
    • treatment failure : hospitalisation for deteriorating respiratory status or lack of improvement of subjective dyspnoea requiring treatment open-label prednisone within 14 days after starting study medication.

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    treatment failure 10 days 8
    (57.14%)    		 0
    (0.00%)    		 100%
    (% to %)    		 57.14%
    (31.22% to 83.07%)    		 2
    (1 to 3)

    Outcome Control Group
    (SD)    		 Experimental Group
    (SD)    		 Mean Difference
    (95% CI)
    mean percentage improvement in PaO 2 -0.70
    ()     		26.2
    ()     		-26.3
    ( to )
    percentage change in FEV 1.00
    ()     		36.9
    ()     		-35.9
    ( to )

  • The change in dyspnoea scale score did not differ between the two groups, but there was a trend towards more rapid improvement in the prednisone group.

    • Comments

    1. Even considering the small sample and the wide 95% CI, the ARR for treatment failure is impressive and supported by changes in physiologic measures.
    2. Further study is needed on the degree of exacerbation that warrants systemic steroids, on characteristics of responders, and on the role of systemic steroids in patients with recurrent exacerbations.

    Citation

    1. Thompson WH, Nielson CP, Carvalho P, et al: Controlled trial of oral prednisone in outpatients with acute COPD exacerbation. American Journal of Critical Care Medicine 1996; 154: 407-412
    Search Terms: COPD and therapy in Medline
    Contributor: Clare Wotton and Musab Hayatli, November 1999
    Reviewer: Roger Luckmann

    Clinical Question.
    Patient acute exacerbation of COPD
    Intervention or Exposure prednisone
    Comparison placebo
    Outcome lung function