Immunization To Prevent Acute COPD Exacerbations

Pfizer530 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

530

Conditions

Pneumococcal Infections COPD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Patient ≥18 years diagnosed with COPD (any stage, the subgroups for the analysis would be based on COPD severity grade) 2. Ability to understand and complete the required QoL questionnaires 3. 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. 4. 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: 1. Impossibility to perform prospective follow up 2. Present any immunocompromising condition 3. 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)

Locations (11)

Hospital Universitario Son Espases

Palma, Balearic Islands, Spain

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, Spain

Hospital el Bierzo

Ponferrada, LEÓN, Spain

Outcomes

Primary Outcomes

Change in Adjusted Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV 13 Population

COPD exacerbations were defined as a complex of two or more respiratory symptoms (worsening dyspnea, cough, sputum production, chest tightness, or wheezing) related to the underlying COPD, with duration of 3 days or more, that required a change in treatment. Moderate exacerbations were those that required antibiotics and/or systemic corticosteroids without hospitalization. Severe exacerbations were those that lead to hospitalization. Adjusted rate of exacerbation was calculated as (Total number of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months.

Time frame: Baseline and Month 24

Change in Adjusted Rate of Moderate/Severe Exacerbations by COPD Severity at Month 24 in PCV13 Population

Moderate exacerbations were those that required antibiotics and/or systemic corticosteroids without hospitalization. Severe exacerbations were those that lead to hospitalization. COPD severity was graded as per GOLD criteria. 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% or FEV1\< 50% plus respiratory failure, FEV1/FVC \< 0.7). Adjusted rate of exacerbation was calculated as (total no. of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months. Change in adjusted rate of moderate/severe exacerbations by COPD severity (Grade 1 and Grade \>1) at Month 24 is reported.

Time frame: Baseline and Month 24

Secondary Outcomes

Change in Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV13 Population by History of Influenza Vaccination

Evaluate the impact of influenza and PCV13 vaccination on the reduction of COPD exacerbations. Adjusted rate of exacerbation was calculated as (total number of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months. Change in rate of moderate/severe exacerbations with and without history of influenza vaccination is presented in this outcome measure.

Data from ClinicalTrials.gov

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Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population

To evaluate the impact of vaccination with PCV13 on patients quality of life SGRQ form was used. It is a self-administered questionnaire developed to measure health status (quality of life) in participants with chronic airflow limitation. The SGRQ consisted of 50 items, where 10 of them were multiple choice and 40 were true or false. Scores were calculated for three domains: Symptoms (eight items; including cough, sputum production, dyspnea or shortness of breath or breathlessness and wheezing, as well as duration, frequency and severity); Activity (16 true or false questions; refers to activities that are limited due to dyspnea);Impacts (26 items; referred to other situations or aspects related to social or psychological functioning affected by the respiratory problems that may alter the participants lifestyle). The total score and scores for each domain ranged from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status).

Time frame: Baseline, Month 12 and 24