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Original Research: COPD |

Oral Immunotherapy With Inactivated Nontypeable Haemophilus influenzae Reduces Severity of Acute Exacerbations in Severe COPD

Maharaj Kishore Tandon, MD; Martin Phillips, MBBS; Grant Waterer, MD, PhD, MBBS, FCCP; Margaret Dunkley, PhD; Phillip Comans, PhD; Robert Clancy, PhD, MBBS
Author and Funding Information

From the Hollywood Private Hospital (Dr Tandon), Perth, WA; Sir Charles Gairdner Hospital (Dr Phillips), Perth, WA; the Lung Institute of Western Australia (Dr Waterer), University of Western Australia, Perth, WA; the University of Newcastle (Drs Dunkley and Clancy), Newcastle, NSW; Hunter Immunology, Ltd. (Drs Dunkley, Comans, and Clancy), Newcastle, NSW; and the John Hunter Hospital (Dr Clancy), Newcastle, NSW, Australia.

Correspondence to: Robert Clancy, PhD, MBBS, Level 4, David Maddison Clinical Sciences Bldg, University of Newcastle, Callaghan NSW 2308, Australia; e-mail: robert.clancy@newcastle.edu.au


Funding/Support: This study was funded by Hunter Immunology Ltd.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestpubs.org/site/misc/reprints.xhtml).


© 2010 American College of Chest Physicians


Chest. 2010;137(4):805-811. doi:10.1378/chest.09-1382
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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 FEV1 ≤ 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.

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