title: Oral immunotherapy with inactivated nontypeable Haemophilus influenzae reduces severity of acute exacerbations in severe COPD.
abstract: BACKGROUND
  Acute exacerbations of COPD reflect in part an inappropriate host response to abnormal bacterial colonization. Orally administered inactivated nontypeable Haemophilus influenzae (NTHi) can drive a specific T-cell response that by promoting intrabronchial phagocytosis down-regulates bronchus inflammation.
  
  
  METHODS
  Subjects with recurrent exacerbations of COPD were studied in a randomized, multicenter, double-blind, placebo-controlled trial, to test efficacy of an NTHi oral immunotherapeutic (HI-164OV). This report describes the outcome in 38 subjects with severe COPD defined as having an FEV(1) < or = 50% of predicted normal.
  
  
  RESULTS
  Exacerbations defined as an increase in volume and purulence of sputum were reduced by 16% (not significant) in the active group. However, moderate-to-severe exacerbations (defined as requiring corticosteroid therapy) were reduced by 63% (P = .05). The proportion with any acute exacerbation was little changed with treatment, but the proportion with episodes requiring corticosteroid therapy was reduced by 56% (P = .07). The mean duration of episodes was reduced by 37% (P = .01) and prescribed courses of antibiotics were reduced by 56% (P = .03) following therapy. Exacerbations requiring admission into hospital were reduced by 90% (P = .04) in the active group. No specific adverse effect was detected.
  
  
  CONCLUSIONS
  Treatment of severe COPD with frequent exacerbations with HI-164OV was safe and effective, especially with respect to reduction in parameters of severity.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry, www.anzctr.org.au; identifier: ACTRN012606000074594.
authors: MBBS, Level 4, David Maddison Clinical Sciences Bldg, University of Newcastle, Callaghan NSW 2308, Australia.
authors: Maharaj Kishore
authors: MK
authors: Tandon
authors: Martin
authors: M
authors: Phillips
authors: Grant
authors: G
authors: Waterer
authors: Margaret
authors: M
authors: Dunkley
authors: Phillip
authors: P
authors: Comans
authors: Robert
authors: R
authors: Clancy
mesh_terms: D000284:Administration, Oral; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006193:Haemophilus influenzae / Q000276:immunology; D006801:Humans; D016233:Immunotherapy, Active / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010587:Phagocytosis / Q000502:physiology; D029424:Pulmonary Disease, Chronic Obstructive / Q000276:immunology / Q000628:therapy*; D012720:Severity of Illness Index; D013601:T-Lymphocytes / Q000502:physiology; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones