A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Single-Season Study to Assess the Efficacy and Safety of HI-164OV Oral Vaccine in Moderate to Severe chronic obstructive pulmonary disease (COPD).

The purpose of this study is to test the safety and efficacy of a new treatment for COPD, HI-164OV, in participants with moderate to severe COPD. COPD (which includes emphysema and chronic bronchitis) causes irreversible damage to the lungs and is the most common respiratory disease in Australia affecting up to 1 in 10 people over the age of 45 years. Exacerbations of symptoms often require hospitalisation and happen most often during the winter months. HI-164OV is an oral vaccine tablet that contains killed non-typeable Haemophilus influenza bacteria, which are commonly found in the sputum of COPD patients. It is hoped that HI-164OV may help reduce the severity, duration and rate of exacerbations in COPD patients. The study is a multi-centre, placebo controlled, randomised, double blind study that will occur over 12 months. It is anticipated that 340 participants, aged 40-85 years, will be randomised in a 1:1 ratio to receive either HI-164OV or placebo. Participants will be asked to take the study medication on three consecutive days each month for the first three months (ie. nine doses in total). Each daily dose of HI-164OV contains 90 mg of HI-164 or placebo. Participants will be asked to attend seven study visits over a nine month period, approximately, for safety and efficacy assessments. Participants will be asked to keep a daily diary during the study to record COPD exacerbation details. Safety will be assessed by collecting data on adverse events, routine clinical laboratory measurements (haematology, biochemistry and sputum), cardio-thoracic physical examination, ECG and vital signs. The efficacy of HI-164OV in reducing the rate and severity of exacerbations in comparison to placebo will be determined by measuring: 1. number of moderate to severe acute COPD exacerbations 2. number of days of antibiotic usage 3. duration of acute exacerbations 4. duration of moderate and severe exacerbations 5. hospitalisations 6. quality of life (using the validated St George’s Respiratory Questionnaire-C)