PPSV23 Pneumococcal Vaccine in Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Streptococcus pneumoniae is the most common causes of community-acquired pneumonia and exacerbations in chronic obstructive pulmonary disease (COPD) patients, which are associated with morbidity, mortality, and higher health-care cost. In addition, recently high daily dose of inhaled corticosteroid (ICS) therapy became more evident to be beneficial in moderate-to-severe COPD patients, but excess risk of pneumonia shown in database analysis was worried about by primary physicians. The use of pneumococcal polysaccharide vaccination (PPSV23) has protective efficacy to eliminate infection of Streptococcus pneumoniae from previous studies. If the use of PPSV23 can reduce the incidence of pneumonia or exacerbations in COPD patients using high daily dose of ICS, the benefit of ICS can be preserved and risk of pneumonia can be reduced. However, there is only limited data supporting this hypothesis. In this study, the investigators will conduct a double-blinded, randomized controlled trial to evaluate the clinical efficacy of PPSV23 in severe COPD patients using high daily dose of ICS.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Far Eastern Memorial Hospital
• Treatments: Heptavalent Pneumococcal Conjugate Vaccine; Vaccines

Criteria

Inclusion Criteria:

1. no previously vaccination with PPSV23,

2. a clinical diagnosis of severe COPD which is defined according to the GOLD 2006 guideline (11): FEV1/FVC < 70%, FEV1 reversibility test < 200 ml, and FEV1 < 50% of predicted,

3. current or past exposure of smoking,

4. no exacerbation in the month prior to enrollment,

5. age < 65 years,

6. using high daily dose of ICS (budesonide > 800-1600 mcg/day or fluticasone > 500-1000 mcg/day),

7. providing written informed consent.

Exclusion Criteria:

1. Patients are excluded from the study if they are pregnant, or have immunosuppressed status (known current neoplasm, renal insufficiency in dialysis, human immunodeficiency virus (HIV) infection, severe hepatic impairment, hypogammaglobulinemia, anatomical or functional asplenia).

2. Asthma, cystic fibrosis, bronchiectasis, and severe sequelae of pulmonary tuberculosis are also excluded by pulmonary function study and chest imaging before patient's enrollment.