PPSV23 Pneumococcal Vaccine in Chronic Obstructive Pulmonary Disease (COPD)

NCT01381367 | Completed Phase 4 DMC

• 1 other identifier: FEMH-97-C-037
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; Inhaled corticosteroid; Pneumococcal vaccine; Acute exacerbation; High-dose daily inhaled corticosteroid usage; Efficacy of the PPSV23 pneumococcal vaccine

Outcome Measures

Primary Outcomes (1)

• the incidence of pneumonia and exacerbations

  1 year

Secondary Outcomes (3)

• time to the first episode of pneumonia or exacerbation

  1 year

• change in lung function (post-bronchodilator FEV1, FVC)

  1 year

• all cause mortality

  1 year

Study Arms (2)

Vaccine

EXPERIMENTAL

Enrolled COPD patients receiving PPSV23 pneumococcal vaccine

Biological: PPSV23 pneumococcal vaccine (Pneumovax®)

Normal saline

PLACEBO COMPARATOR

Enrolled COPD patient receiving placebo normal saline

Drug: Normal Saline

Interventions

PPSV23 pneumococcal vaccine (Pneumovax®) BIOLOGICAL

The adult anti-pneumococcal vaccine was a 23-polyvalent pneumococcal vaccine (Pneumovax®, Aventis Pastuer MSD), 0.5 ml of which was given subcutaneously. Duration of the efficacy is about 4-5 years.

Also known as: Pneumovax®, Aventis Pastuer MSD

Vaccine

Normal Saline DRUG

normal saline, 0.5ml given subcutaneously

Normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• no previously vaccination with PPSV23,
• 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,
• current or past exposure of smoking,
• no exacerbation in the month prior to enrollment,
• age \< 65 years,
• using high daily dose of ICS (budesonide \> 800-1600 mcg/day or fluticasone \> 500-1000 mcg/day),
• providing written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, Taipei, 220, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Pneumococcal Vaccines; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ming-Tzer Lin, MD

  Far Eastern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: June 27, 2011
• Study Start: February 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

TW (1)