Chronic Obstructive Pulmonary DiseasePhase 4NCT01381367
PPSV23 Pneumococcal Vaccine in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study testing PPSV23 pneumococcal vaccine (Pneumovax®) and Normal Saline in people with Chronic Obstructive Pulmonary Disease, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- PPSV23 pneumococcal vaccine (Pneumovax®) and Normal Saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2009to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of PPSV23 Pneumococcal Vaccine in COPD Patients Using High Daily Dose of Inhaled Corticosteroid
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.
Read the detailed description
Exacerbations are a common feature in moderate-to-severe chronic obstructive pulmonary disease (COPD). Morbidity, mortality and health-care costs of these patients largely result from exacerbations. The most common causes of an exacerbation are infection of tracheobronchial tree. Among them, Streptococcus pneumoniae is the most frequently isolated organism, accounting for 5-25% patients of COPD, while it is also the most commonly identified cause in community-acquired pneumonia (CAP), accounting for 16.5-38.9% of CAP patients.
In recent years, widespread emergence of antimicrobial resistance in Streptococcus pneumoniae has became a major global concern, especially in Taiwan, one of the highest levels of antibiotic-resistant pneumococci in the world. Therefore, primary prevention by vaccination is encouraged for those high-risk patients with COPD. The currently available adult pneumococcal vaccine consists of the capsular polysaccharide of 23 different serotypes of Streptococcus pneumoniae (PPSV23). The antibodies produced in response to this polysaccharide can provide protection by inducing host immune cells to kill or to opsonize bacteria for phagocytosis.
Until now, few studies have been designed to specifically examine vaccine efficacy in COPD patients. Among 3 available randomized controlled trials, only one study involving 596 patients found, from post-hoc analyses, some protective efficacy for pneumonia in patients of < 65 years of age and of an FEV1 < 40% predicted. Based on above evidence (only limited body of data), the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guideline has recommended the PPSV23 inoculation as evidence B.
By the way, in comparison to placebo and the single components, a superior control by means of the inhaled corticosteroids (ICS)/long-acting beta2-agonist (LABA) fixed combination therapy has been demonstrated for significant clinical improvement in moderate-to-severe COPD patients, except mortality, by meta-analysis and large prospective studies (TORCH [Towards a Revolution in COPD Health] trial and INSPIRE [Investigating New Standards for Prophylaxis in Reduction of Exacerbations] trial). However, those database indicated that high daily dose of ICS (fluticasone propionate at a dose of 500-1000mcg daily) was associated with an excess risk of pneumonia, which doubles the pneumonia incidence in patients not receiving ICS. The immunogenicity of PPSV23 in COPD patients using systemic steroid was demonstrated but the clinical efficacy of vaccination has not been investigated.
From above-mentioned background, 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. For primary physicians, this hypothesis, if true, is very beneficial. So, in this study, the investigators want to conduct a double-blinded, randomized controlled trial to evaluate the clinical efficacy of PPSV23 in COPD patients using high daily dose of ICS.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- PPSV23 pneumococcal vaccine (Pneumovax®), Normal Saline
- Keywords
- Chronic obstructive pulmonary disease, Inhaled corticosteroid, Pneumococcal vaccine, Acute exacerbation, High-dose daily inhaled corticosteroid usage, Efficacy of the PPSV23 pneumococcal vaccine
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPSV23 pneumococcal vaccine (Pneumovax®)Biological
Also called Pneumovax®, Aventis Pastuer MSD
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.
Normal SalineDrug
normal saline, 0.5ml given subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | Enrolled COPD patients receiving PPSV23 pneumococcal vaccine Receives: Biological: PPSV23 pneumococcal vaccine (Pneumovax®) |
| Normal saline | Placebo comparator | Enrolled COPD patient receiving placebo normal saline Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of pneumonia and exacerbations
Measured: 1 year
Secondary outcomes (3)
time to the first episode of pneumonia or exacerbation
Measured: 1 year
change in lung function (post-bronchodilator FEV1, FVC)
Measured: 1 year
all cause mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startFeb 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ming-Tzer Lin, MD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381367
- Sponsor's protocol ID
- FEMH-97-C-037
- Status last verified
- Jun 2011
- First submitted
- 16 Feb 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of PPSV23 Pneumococcal Vaccine in COPD Patients Using High Daily Dose of Inhaled Corticosteroid
- ClinicalTrials.gov ID
- NCT01381367
- Acronym / sponsor ID
- FEMH-97-C-037
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Exacerbations are a common feature in moderate-to-severe chronic obstructive pulmonary disease (COPD). Morbidity, mortality and health-care costs of these patients largely result from exacerbations. The most common causes of an exacerbation are infection of tracheobronchial tree. Among them, Streptococcus pneumoniae is the most frequently isolated organism, accounting for 5-25% patients of COPD, while it is also the most commonly identified cause in community-acquired pneumonia (CAP), accounting for 16.5-38.9% of CAP patients.
In recent years, widespread emergence of antimicrobial resistance in Streptococcus pneumoniae has became a major global concern, especially in Taiwan, one of the highest levels of antibiotic-resistant pneumococci in the world. Therefore, primary prevention by vaccination is encouraged for those high-risk patients with COPD. The currently available adult pneumococcal vaccine consists of the capsular polysaccharide of 23 different serotypes of Streptococcus pneumoniae (PPSV23). The antibodies produced in response to this polysaccharide can provide protection by inducing host immune cells to kill or to opsonize bacteria for phagocytosis.
Until now, few studies have been designed to specifically examine vaccine efficacy in COPD patients. Among 3 available randomized controlled trials, only one study involving 596 patients found, from post-hoc analyses, some protective efficacy for pneumonia in patients of < 65 years of age and of an FEV1 < 40% predicted. Based on above evidence (only limited body of data), the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guideline has recommended the PPSV23 inoculation as evidence B.
By the way, in comparison to placebo and the single components, a superior control by means of the inhaled corticosteroids (ICS)/long-acting beta2-agonist (LABA) fixed combination therapy has been demonstrated for significant clinical improvement in moderate-to-severe COPD patients, except mortality, by meta-analysis and large prospective studies (TORCH [Towards a Revolution in COPD Health] trial and INSPIRE [Investigating New Standards for Prophylaxis in Reduction of Exacerbations] trial). However, those database indicated that high daily dose of ICS (fluticasone propionate at a dose of 500-1000mcg daily) was associated with an excess risk of pneumonia, which doubles the pneumonia incidence in patients not receiving ICS. The immunogenicity of PPSV23 in COPD patients using systemic steroid was demonstrated but the clinical efficacy of vaccination has not been investigated.
From above-mentioned background, 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. For primary physicians, this hypothesis, if true, is very beneficial. So, in this study, the investigators want to conduct a double-blinded, randomized controlled trial to evaluate the clinical efficacy of PPSV23 in COPD patients using high daily dose of ICS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: PPSV23 pneumococcal vaccine (Pneumovax®)Enrolled COPD patients receiving PPSV23 pneumococcal vaccine |
| Normal saline | Placebo comparator | Drug: Normal SalineEnrolled COPD patient receiving placebo normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PPSV23 pneumococcal vaccine (Pneumovax®)Also: Pneumovax®, Aventis Pastuer MSDThe 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. | Biological | Vaccine |
| Normal Salinenormal saline, 0.5ml given subcutaneously | Drug | Normal saline |
Primary outcome
the incidence of pneumonia and exacerbations
Time frame: 1 year
3 secondary outcomes
time to the first episode of pneumonia or exacerbation
Time frame: 1 year
change in lung function (post-bronchodilator FEV1, FVC)
Time frame: 1 year
all cause mortality
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Tzer Lin, MD principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PPSV23 pneumococcal vaccine (Pneumovax®) and Normal Saline in people with Chronic Obstructive Pulmonary Disease, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of pneumonia and exacerbations (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.