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. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, www.anzctr.org.au; identifier: ACTRN012606000074594.
RCT Entities:
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. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, www.anzctr.org.au; identifier: ACTRN012606000074594.
Authors: Edward Teo; Kathleen Lockhart; Sai Navya Purchuri; Jennifer Pushparajah; Allan W Cripps; Mieke L van Driel Journal: Cochrane Database Syst Rev Date: 2017-06-19
Authors: Philip L Molyneaux; Patrick Mallia; Michael J Cox; Joseph Footitt; Saffron A G Willis-Owen; Daniel Homola; Maria-Belen Trujillo-Torralbo; Sarah Elkin; Onn Min Kon; William O C Cookson; Miriam F Moffatt; Sebastian L Johnston Journal: Am J Respir Crit Care Med Date: 2013-11-15 Impact factor: 21.405