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).

Trial Profile

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).

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 08 Jun 2016

At a glance

  • Drugs HI 164 (Primary)
  • Indications Bacterial infections; Chronic obstructive pulmonary disease
  • Focus Therapeutic Use
  • Most Recent Events

    • 28 Jun 2012 Primary endpoint 'Symptom-exacerbation-rate' has not been met.
    • 29 May 2012 Status changed from recruiting to active, no longer recruiting, according to a Bioxyne media release.
    • 12 Apr 2012 Data are expected to be released in mid-2012, according to a Bioxyne media release.
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