A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Single-Season Study to Assess the Efficacy and Safety of HI-164OV, an Enteric-coated Oral Vaccine Tablet Containing 45 mg HI-164 Active Substance (Inactivated, Whole Cells of Non-typeable Haemophilus influenzae, isolate 164) for Reducing the Rate and Severity of Acute Exacerbations in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).

Start Date12 Jan 2011

Sponsor / Collaborator

Hunter Immunology Pty Ltd.

100 Clinical Results associated with HI-164

100 Translational Medicine associated with HI-164

100 Patents (Medical) associated with HI-164

Literatures (Medical) associated with HI-164

01 Apr 2010·ChestQ1 · MEDICINE

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

Q1 · MEDICINE

Article

Author: Grant Waterer ; Margaret Dunkley ; Robert Clancy ; Phillip Comans ; Maharaj Kishore Tandon ; Martin Phillips

BACKGROUNDAcute 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.METHODSSubjects 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.RESULTSExacerbations 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.CONCLUSIONSTreatment of severe COPD with frequent exacerbations with HI-164OV was safe and effective, especially with respect to reduction in parameters of severity.TRIAL REGISTRATIONAustralian New Zealand Clinical Trials Registry, www.anzctr.org.au; identifier: ACTRN012606000074594.

100 Deals associated with HI-164

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Disease, Chronic Obstructive	Phase 2	-	Hunter Immunology Pty Ltd.	-
Bronchitis	Phase 1	AU	-	-
Otitis Media	Phase 1	AU	-	-
Sinusitis	Phase 1	AU	-	-

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