Immunization To Prevent Acute COPD Exacerbations

Study Overview
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Brief Summary
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Prospective multicenter observational study, to evaluate the impact of routine clinical practice vaccination with PCV13 on the reduction of the risk of moderate/severe COPD exacerbations

Detailed Description
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Patients with chronic obstructive pulmonary disease (COPD) have been demonstrated to have an increased risk of pneumococcal disease. Pneumonia is frequent among patients hospitalized for COPD exacerbations and is associated with increased health care utilization and higher mortality. Up to 50%-70% of exacerbations can be attributed to respiratory infections by viruses or bacteria, even more in the most severe patients. They are often associated with the colonization of airways by multiple bacteria or viruses of low virulence that in normal conditions are parts of the normal flora of the upper airway. Current recommendations for immunization of patients with COPD include vaccination against influenza and Streptococcus pneumoniae. The aim of this study is to evaluate the potential benefits of immunization of COPD patients with PCV13 and/or against influenza in terms of clinical benefits and quality of life.

Official Title
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IMMUNIZATION TO PREVENT ACUTE COPD EXACERBATIONS (IMPACE STUDY)

Conditions
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Pneumococcal Infections, COPD

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patient ≥18 years diagnosed with COPD (any stage, the subgroups for the analysis would be based on COPD severity grade) Ability to understand and complete the required QoL questionnaires At least 2 years of clinical history available that includes records of previous moderate/severe exacerbations, influenza and pneumococcal vaccination history comorbidities and previous treatments. Spirometry data (maximum 6 months old, or if not available at enrollment, to be performed as per normal clinical practice at visit 1 +/- one month) Exclusion criteria: Impossibility to perform prospective follow up Present any immunocompromising condition Present any other respiratory diseases as co-morbidity (subjects with overlap syndromes COPD-asthma will be excluded. Mixed phenotype defined as: symptoms of increased variability of airflow and incompletely reversible airflow obstruction)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Incidence of moderate or severe COPD exacerbations | Total number of COPD exacerbations reported by participant / follow up time. Moderate COPD exacerbation: those that require antibiotics and/or systemic corticosteroids without hospitalization. Severe COPD exacerbation: those that lead to hospitalization | 2 years | 
| COPD severity | COPD severity classification (GOLD): GRADE 1: Mild/unknown [FEV1≥ 80%, FEV1/FVC < 0,7 or no spirometry data] GRADE 2: Moderate [50% ≤ FEV1< 80%,FEV1/FVC < 0,7] GRADE 3: Severe [30% ≤ FEV1 < 50%, FEV1/FVC < 0,7] GRADE 4: Very severe [FEV1< 30% o FEV1< 50% plus respiratory failure,FEV1/FVC < 0,7]) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Saint George Respiratory Questionnaire Score | The SGRQ is a specific questionnaire developed to measure health status (quality of life) in patients with chronic airflow limitation. Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). | 2 years | 
| Change in CAT (COPD Assessment Tool) questionnaire score | COPD Assessment Tool is a simple questionnaire that may be used to determine the severity of symptoms. Scores on CAT range from 0-40 with the higher the score, the more severe the disease. | 2 years | 
| Change in FEV1 from baseline | FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed as routine clinical practice | 2 years | 
| Percentage of participants vaccinated with PCV13 | Percentage of participants vaccinated with PCV13 | 2 years | 
| Change in number of COPD exacerbations/patient/year | Total number of exacerbations reported by participant / follow up time | 2 years | 
| Mean cost per participant | Overall cost of hospitalization and/or treatment of exacerbation episode based on days of hospitalization /ICU and treatment received. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal infections, COPD exacerbations