CompletedPhase 2ACTRN12610000916044

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).

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).

Sponsor

Hunter Immunology Limited

Enrollment

340 participants

Start Date

Jan 12, 2011

Study Type

Interventional

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Summary

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)

Eligibility

Sex: Both males and femalesMin Age: 40 YearssMax Age: 85 Yearss

Inclusion Criteria4

40 to 85 years of age.
History of 1 moderate or severe acute COPD exacerbation in the previous 12 months
An established diagnosis of COPD and severity status of moderate to severe defined by a post bronchodilator FEV1 <60% of predicted value and post-bronchodilator FEV1/FVC < 0.7.
Willingness and ability to give signed informed consent.

Exclusion Criteria16

Planned or previous lung transplantation, lung volume reduction surgery, or other lung surgery for emphysema.
A primary diagnosis of bronchiectasis.
Current respiratory disorders other than COPD (e.g., lung cancer, sarcoidosis, tuberculosis, restrictive lung disease/benign tumours).
History of asthma as primary diagnosis as an adult.
Unresolved acute COPD exacerbation.
6. Oral/parenteral corticosteroids in excess of 10 mg/day, or antibiotics taken for all acute conditions (including acute exacerbations of COPD), within four weeks of the scheduled first dose of study medication. This does not apply to background antibiotic maintenance therapy.
New therapy or a change in dose of existing therapy for COPD, including, but not limited to, inhaled bronchodilators and inhaled corticosteroids, started within 4 weeks prior to the first dose of study medication.
Participation in a clinical trial of any other vaccine, drug, or immune stimulating agent within three months of screening and for the duration of the study.
History of systemic immunosuppressive therapy (including systemic corticosteroids at an equivalent prednisone dose of >10 mg/day) within 4 weeks prior to randomisation.
Women who are pregnant, breast-feeding, or of child-bearing potential without effective contraception.
Any significant medical disorder which would preclude evaluation of the participant's condition. Participants with impaired hepatic function defined as raised liver function tests greater than 2.5 times upper limit of normal range.
Participants with impaired renal function defined as serum creatinine > 177 umol/L.
Cancer within the previous five years (except for non-melanomatous skin cancer and non-invasive cervical cancer).
Life expectancy of less than 1 year.
Participants with lactose intolerance.
Any other medical or social reason the Investigator feels justifies exclusion of the participant, including being likely to withdraw, not comply or be able to understand the protocol requirements.

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Interventions

Oral vaccine tablet containing 45 mg HI-164 active product. Participants will be asked to take the study medication on three consecutive days each month for the first three months (ie. nine doses

Oral vaccine tablet containing 45 mg HI-164 active product. 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 and will be taken orally approximately one hour prior to breakfast.