Chronic obstructive pulmonary disease: immunostimulating agents had no clear effect.

Clinical bottom line (level 1b-)

  1. Patients with chronic obstructive pulmonary disease who were given an immunostimulating agent, had no clear difference in one or more episodes of acute exacerbation than those given placebo.
  2. Patients given an immunostimulating agent had no clear difference in hospitalisations than those given placebo.
Collet et al: American Journal of Respiratory Critical Care Medicine 1997; 156: 1719-1724
Expires November 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 12 institutions, Canada

381 patients (aged mean 66 years, 70% male) COPD with a history of heavy smoking ( = 20 pack-years) and a FEV1 value between 20 and 70% of predicted, which improved less than 15% after salbutamol (200 µ g by inhalation)

Excluded if
  • severe concomitant disease making follow-up difficult or unlikely
  • prescribed medication affecting the immune system (ie. immunosuppressants or systemic corticosteroids for more than 2 weeks in the last month)
  • episode of acute exacerbation treated with antibiotics within the previous month
  • living too far from study centre, making follow-up difficult


    • Control Group: (n = 190, 190 analysed): placebo
    Experimental Group: (n = 191, 191 analysed): immunostimulating agent OM-85 Broncho-Vaxom - 1 capsule per day on an empty stomach in the morning every day for 30 days followed by a repeat course of 10 consecutive days of therapy per month for 3 months
    All patients were given an influenza vaccine. Compliance of pill taking was ascertained by a structured interview of the patient on drug use, by monitoring a symptom diary in which patients had to report the use of medication and by collection of the empty medication blister packs and counting the leftover pills.
    100% followed for 6 months

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    occurrence of 1 or more episodes of acute exacerbations 6 months 83
    (43.68%)    		 85
    (44.5%)    		 -2%
    (-28% to 19%)    		 -0.82%
    (-10.79% to 9.15%)    		 -122
    (NNT = 11 to infinity;
    NNH = 9 to infinity)
    number of hospitalisations 6 months 44
    (23.16%)    		 31
    (16.23%)    		 30.0%
    (-6.00% to 54.0%)    		 6.93%
    (-1.03% to 14.9%)    		 14
    (NNT = 7 to infinity;
    NNH = 97 to infinity)

    Comments

    1. The trial was too small to show any difference in acute exacerbations or hospitalisations between the two groups.

    Citation

    1. Collet JP, Shapiro S, Ernst P, et al: Effects of an immunostimulating agent on acute exacerbations and hospitalisations in patients with chronic obstructive pulmonary disease. American Journal of Respiratory Critical Care Medicine 1997; 156: 1719-1724
    Search Terms: COPD, chronic obstructive pulmonary disease and therapy in Medline
    Contributor: Clare Wotton and Musab Hayatli, November 1999
    Reviewer: Mitsuhiro Kamei

    Clinical Question.
    Patient COPD
    Intervention or Exposure immunostimulating agent
    Comparison placebo
    Outcome number of exacerbations and hospitalisations