COPD, Pneumococcal Infections
Conditions
Keywords
Pneumococcal infections, COPD exacerbations
Brief summary
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
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.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Adjusted Rate of Moderate/Severe Exacerbations by COPD Severity at Month 24 in PCV13 Population | Baseline and Month 24 | 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. |
| Change in Adjusted Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV 13 Population | Baseline and Month 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population | Baseline, Month 12 and 24 | 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). |
| Change From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population | Baseline, Month 12 and 24 | To evaluate the impact of vaccination with PCV13 on patients quality of life ,CAT questionnaire is used. It is used to measure the impact COPD on the participant's wellbeing and daily life and severity of symptoms. The CAT has 8 questions, with score ranging from 0 to 5 for each question, where 0 = no impairment and 5=severe impairment. Total score was calculated as the sum of scores of individual questions and ranged from 0 to 40 with higher scores indicating more severe disease. |
| Percentage of Participants With COPD Vaccinated With PCV13 | Up to Month 24 | Percentage of evaluable study participants vaccinated with PCV13 prior or after inclusion in the study. |
| Change From Baseline in Forced Expiratory Volume (FEV1) at Month 24 in PCV13 Population | Baseline, Month 24 | To evaluate the impact of vaccination with PCV13 on the decrease of FEV1 was evaluated. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. |
| Change in Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV13 Population by History of Influenza Vaccination | Month 24 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Cost Saving Per COPD Participant With PCV13 | Up to Month 24 | Overall cost of hospitalization and/or treatment of exacerbation episode based on days of hospitalization or Intensive care unit and treatment received were planned to be analyzed in this outcome measure. |
Countries
Spain
Participant flow
Recruitment details
Participants diagnosed with Chronic Obstructive Pulmonary Disease (COPD) across 11 hospitals in Spain were followed up during their routine follow-up visits in this prospective observational study. Participants were prescribed therapies in line with routine clinical practice.
Pre-assignment details
A total of 530 evaluable participants were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| Participants With COPD Participants with COPD having at least 2 years of prior medical record including history of moderate/severe exacerbations, influenza and pneumococcal vaccination history, comorbidities and previous treatments were observed in this prospective study.
Participants were prescribed therapies in line with routine clinical practice. | 530 |
| Total | 530 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 39 |
| Overall Study | Lost to Follow-up | 27 |
| Overall Study | No data reported at Month 24 | 31 |
| Overall Study | Presence of any immunosuppressive condition | 8 |
| Overall Study | Withdrawal of informed consent | 4 |
Baseline characteristics
| Characteristic | Participants With COPD | — |
|---|---|---|
| Age, Continuous Overall | 70.2 Years STANDARD_DEVIATION 7.9 | — |
| Age, Continuous PCV13 Population | 69.2 Years STANDARD_DEVIATION 7.9 | — |
| Age, Continuous Without pneumococcal vaccination | 68.2 Years STANDARD_DEVIATION 8.4 | — |
| Age, Continuous With pneumococcal vaccination | 70.8 Years STANDARD_DEVIATION 7.7 | — |
| Alcohol consumption Overall No | 511 Participants | — |
| Alcohol consumption Overall Yes | 19 Participants | — |
| Alcohol consumption PCV13 Population No | 112 Participants | — |
| Alcohol consumption PCV13 Population Yes | 2 Participants | — |
| Alcohol consumption Without Pneumococcal Vaccination No | 118 Participants | — |
| Alcohol consumption Without Pneumococcal Vaccination Yes | 8 Participants | — |
| Alcohol consumption With Pneumococcal Vaccination No | 393 Participants | — |
| Alcohol consumption With Pneumococcal Vaccination Yes | 11 Participants | — |
| Body Mass Index Overall | 27.5 Kilograms per meter square STANDARD_DEVIATION 5.1 | — |
| Body Mass Index PCV13 Population | 27.7 Kilograms per meter square STANDARD_DEVIATION 4.8 | — |
| Body Mass Index Without pneumococcal vaccination | 27.4 Kilograms per meter square STANDARD_DEVIATION 5.8 | — |
| Body Mass Index With pneumococcal vaccination | 27.6 Kilograms per meter square STANDARD_DEVIATION 4.8 | — |
| Conjugate pneumococcal vaccination (PCV13) prior to study inclusion Overall: No | 306 Participants | — |
| Conjugate pneumococcal vaccination (PCV13) prior to study inclusion Overall: Yes | 224 Participants | — |
| Conjugate pneumococcal vaccination (PCV13) prior to study inclusion Overall: Yes (Not received influenza vaccine in the same year) | 12 Participants | — |
| Conjugate pneumococcal vaccination (PCV13) prior to study inclusion Overall: Yes (Received influenza vaccine in the same year) | 212 Participants | — |
| Conjugate pneumococcal vaccination (PCV13) prior to study inclusion Without pneumococcal vaccination: No | 126 Participants | — |
| Conjugate pneumococcal vaccination (PCV13) prior to study inclusion Without pneumococcal vaccination: Yes | 0 Participants | — |
| Conjugate pneumococcal vaccination (PCV13) prior to study inclusion Without pneumococcal vaccination: Yes (Not received influenza vaccine in the same year) | 0 Participants | — |
| Conjugate pneumococcal vaccination (PCV13) prior to study inclusion Without pneumococcal vaccination: Yes (Received influenza vaccine in the same year | 0 Participants | — |
| Conjugate pneumococcal vaccination (PCV13) prior to study inclusion With pneumococcal vaccination: No | 180 Participants | — |
| Conjugate pneumococcal vaccination (PCV13) prior to study inclusion With pneumococcal vaccination: Yes | 224 Participants | — |
| Conjugate pneumococcal vaccination (PCV13) prior to study inclusion With pneumococcal vaccination: Yes (Not received influenza vaccine in the same year) | 12 Participants | — |
| Conjugate pneumococcal vaccination (PCV13) prior to study inclusion With pneumococcal vaccination: Yes (Received influenza vaccine in the same year | 212 Participants | — |
| COPD severity (GOLD) Overall Grade 1: Mild/unknown | 55 Participants | — |
| COPD severity (GOLD) Overall Grade 2: Moderate | 218 Participants | — |
| COPD severity (GOLD) Overall Grade 3: Severe | 178 Participants | — |
| COPD severity (GOLD) Overall Grade 4: Very severe | 79 Participants | — |
| COPD severity (GOLD) PCV13 Population Grade 1: Mild/unknown | 12 Participants | — |
| COPD severity (GOLD) PCV13 Population Grade 2: Moderate | 47 Participants | — |
| COPD severity (GOLD) PCV13 Population Grade 3: Severe | 36 Participants | — |
| COPD severity (GOLD) PCV13 Population Grade 4: Very severe | 19 Participants | — |
| COPD severity (GOLD) Without Pneumococcal Vaccination Grade 1: Mild/unknown | 14 Participants | — |
| COPD severity (GOLD) Without Pneumococcal Vaccination Grade 2: Moderate | 44 Participants | — |
| COPD severity (GOLD) Without Pneumococcal Vaccination Grade 3: Severe | 50 Participants | — |
| COPD severity (GOLD) Without Pneumococcal Vaccination Grade 4: Very severe | 18 Participants | — |
| COPD severity (GOLD) With Pneumococcal Vaccination Grade 1: Mild/unknown | 41 Participants | — |
| COPD severity (GOLD) With Pneumococcal Vaccination Grade 2: Moderate | 174 Participants | — |
| COPD severity (GOLD) With Pneumococcal Vaccination Grade 3: Severe | 128 Participants | — |
| COPD severity (GOLD) With Pneumococcal Vaccination Grade 4: Very severe | 61 Participants | — |
| FEV1/FVC Ratio Overall | 49.3 Percentage STANDARD_DEVIATION 11.3 | — |
| FEV1/FVC Ratio PCV13 Population | 48.0 Percentage STANDARD_DEVIATION 12.8 | — |
| FEV1/FVC Ratio Without Pneumococcal Vaccination | 49.5 Percentage STANDARD_DEVIATION 12.1 | — |
| FEV1/FVC Ratio With Pneumococcal Vaccination | 49.2 Percentage STANDARD_DEVIATION 11 | — |
| Forced Expiratory Volume (FEV1) Overall | 53.4 Percentage STANDARD_DEVIATION 18.6 | — |
| Forced Expiratory Volume (FEV1) PCV13 Population | 51.9 Percentage STANDARD_DEVIATION 19 | — |
| Forced Expiratory Volume (FEV1) Without Pneumococcal Vaccination | 52.1 Percentage STANDARD_DEVIATION 19.9 | — |
| Forced Expiratory Volume (FEV1) With Pneumococcal Vaccination | 53.8 Percentage STANDARD_DEVIATION 18.2 | — |
| Forced Vital Capacity (FVC) Overall | 83.0 Percentage STANDARD_DEVIATION 21.4 | — |
| Forced Vital Capacity (FVC) PCV13 Population | 84.5 Percentage STANDARD_DEVIATION 22.1 | — |
| Forced Vital Capacity (FVC) Without Pneumococcal Vaccination | 82.3 Percentage STANDARD_DEVIATION 22.4 | — |
| Forced Vital Capacity (FVC) With Pneumococcal Vaccination | 83.2 Percentage STANDARD_DEVIATION 21.2 | — |
| Height Overall | 164.7 Centimeters STANDARD_DEVIATION 8.4 | — |
| Height PCV13 Population | 164.9 Centimeters STANDARD_DEVIATION 7.9 | — |
| Height Without pneumococcal vaccination | 163.8 Centimeters STANDARD_DEVIATION 9.2 | — |
| Height With pneumococcal vaccination | 164.9 Centimeters STANDARD_DEVIATION 8.1 | — |
| History of influenza vaccination Overall No | 57 Participants | — |
| History of influenza vaccination Overall Yes | 473 Participants | — |
| History of influenza vaccination PCV13 Population No | 19 Participants | — |
| History of influenza vaccination PCV13 Population Yes | 95 Participants | — |
| History of influenza vaccination Without Pneumococcal Vaccination No | 48 Participants | — |
| History of influenza vaccination Without Pneumococcal Vaccination Yes | 78 Participants | — |
| History of influenza vaccination With Pneumococcal Vaccination No | 9 Participants | — |
| History of influenza vaccination With Pneumococcal Vaccination Yes | 395 Participants | — |
| Most frequent treatments for COPD at baseline Overall: No | 3 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes | 527 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (Antibiotics-macrolides) | 18 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (IC + LABA) | 137 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (IC + LABA + LAMA) | 173 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (IC + LAMA) | 2 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (IC+ Theophylline) | 1 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (LABA) | 10 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (LABA + LAMA) | 237 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (LAMA) | 143 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (Others) | 57 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (PDE4 inhibitors + LABA) | 2 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (PDE4 inhibitors + LABA + LAMA | 12 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (PDE4 inhibitors + LAMA) | 7 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (PDE4 inhibitors-NAC) | 13 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (SABA) | 221 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (SAMA) | 35 Participants | — |
| Most frequent treatments for COPD at baseline Overall: Yes (Theophylline + LABA + LAMA) | 5 Participants | — |
| Most frequent treatments for COPD at baseline PCV13 Population: Yes | 114 Participants | — |
| Most frequent treatments for COPD at baseline PCV13 Population: Yes (Antibiotics-macrolides) | 1 Participants | — |
| Most frequent treatments for COPD at baseline PCV13 Population: Yes (IC + LABA + LAMA) | 34 Participants | — |
| Most frequent treatments for COPD at baseline PCV13 Population: Yes (IC+ LAMA) | 1 Participants | — |
| Most frequent treatments for COPD at baseline PCV13 Population: Yes (Inhaled corticosteroids - IC+ LABA) | 29 Participants | — |
| Most frequent treatments for COPD at baseline PCV13 Population: Yes (LABA) | 2 Participants | — |
| Most frequent treatments for COPD at baseline PCV13 Population: Yes (LABA + LAMA) | 52 Participants | — |
| Most frequent treatments for COPD at baseline PCV13 Population: Yes (LAMA) | 39 Participants | — |
| Most frequent treatments for COPD at baseline PCV13 Population: Yes (Others) | 9 Participants | — |
| Most frequent treatments for COPD at baseline PCV13 Population: Yes (PDE4 inhibitors + LABA + LAMA) | 1 Participants | — |
| Most frequent treatments for COPD at baseline PCV13 Population: Yes (PDE4 inhibitors: NAC) | 2 Participants | — |
| Most frequent treatments for COPD at baseline PCV13 Population: Yes (SABA) | 49 Participants | — |
| Most frequent treatments for COPD at baseline PCV13 Population: Yes (SAMA) | 8 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: No | 2 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes | 124 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (Antibiotics-Macrolides) | 3 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (IC + LABA) | 42 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (IC + LABA + LAMA) | 30 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (IC + LAMA) | 1 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (IC + Theophylline) | 1 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (LABA) | 2 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (LABA + LAMA) | 63 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (LAMA) | 46 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (Others) | 21 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (PDE4 inhibitors + LABA) | 0 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (PDE4 inhibitors + LABA + LAMA) | 0 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (PDE4 inhibitors + LAMA) | 1 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (PDE4 inhibitors-NAC) | 0 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (SABA) | 58 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (SAMA) | 15 Participants | — |
| Most frequent treatments for COPD at baseline Without Pneumococcal Vaccination: Yes (Theophylline + LABA + LAMA) | 0 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: No | 1 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes | 403 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (Antibiotics-Macrolides) | 15 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (IC + LABA) | 95 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (IC + LABA + LAMA) | 143 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (IC + LAMA) | 1 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (IC + Theophylline) | 0 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (LABA) | 8 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (LABA + LAMA) | 174 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (LAMA) | 97 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (Others) | 36 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (PDE4 inhibitors + LABA) | 2 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (PDE4 inhibitors + LABA + LAMA) | 12 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (PDE4 inhibitors + LAMA) | 6 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (PDE4 inhibitors-NAC) | 13 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (SABA) | 163 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (SAMA) | 20 Participants | — |
| Most frequent treatments for COPD at baseline With Pneumococcal Vaccination: Yes (Theophylline + LABA + LAMA) | 5 Participants | — |
| Number of moderate/severe exacerbations prior to study inclusion Overall | 3.3 Exacerbation per participant in 24 month STANDARD_DEVIATION 3.2 | — |
| Number of moderate/severe exacerbations prior to study inclusion PCV13 Population | 2.4 Exacerbation per participant in 24 month STANDARD_DEVIATION 1.6 | — |
| Number of moderate/severe exacerbations prior to study inclusion Without Pneumococcal Vaccination | 2.9 Exacerbation per participant in 24 month STANDARD_DEVIATION 2.7 | — |
| Number of moderate/severe exacerbations prior to study inclusion With Pneumococcal Vaccination | 3.5 Exacerbation per participant in 24 month STANDARD_DEVIATION 3.3 | — |
| Pneumococcal vaccination prior to study inclusion Overall: No | 126 Participants | — |
| Pneumococcal vaccination prior to study inclusion Overall: Yes | 404 Participants | — |
| Pneumococcal vaccination prior to study inclusion Overall: Yes, Conjugate only (PCV13) | 82 Participants | — |
| Pneumococcal vaccination prior to study inclusion Overall: Yes, Polysaccharide only (PPSV23) | 180 Participants | — |
| Pneumococcal vaccination prior to study inclusion Overall: Yes, Polysaccharide (PPSV23) + Conjugate (PCV13) | 142 Participants | — |
| Pneumococcal vaccination prior to study inclusion Without pneumococcal vaccination: No | 126 Participants | — |
| Pneumococcal vaccination prior to study inclusion Without pneumococcal vaccination: Yes | 0 Participants | — |
| Pneumococcal vaccination prior to study inclusion Without pneumococcal vaccination: Yes, Conjugate only (PCV13) | 0 Participants | — |
| Pneumococcal vaccination prior to study inclusion Without pneumococcal vaccination: Yes, Polysaccharide only (PPSV23) | 0 Participants | — |
| Pneumococcal vaccination prior to study inclusion Without pneumococcal vaccination: Yes, Polysaccharide (PPSV23) + Conjugate (PCV13) | 0 Participants | — |
| Pneumococcal vaccination prior to study inclusion With pneumococcal vaccination: No | 0 Participants | — |
| Pneumococcal vaccination prior to study inclusion With pneumococcal vaccination: Yes | 404 Participants | — |
| Pneumococcal vaccination prior to study inclusion With pneumococcal vaccination: Yes, Conjugate only (PCV13) | 82 Participants | — |
| Pneumococcal vaccination prior to study inclusion With pneumococcal vaccination: Yes, Polysaccharide only (PPSV23) | 180 Participants | — |
| Pneumococcal vaccination prior to study inclusion With pneumococcal vaccination: Yes, Polysaccharide (PPSV23) + Conjugate (PCV13) | 142 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Relevant Medical History Overall: Medical History- No | 39 Participants | — |
| Relevant Medical History Overall: Medical History- Yes | 491 Participants | — |
| Relevant Medical History Overall: Medical History- Yes (Arterial hypertension) | 279 Participants | — |
| Relevant Medical History Overall: Medical History- Yes (Cardiac failure) | 37 Participants | — |
| Relevant Medical History Overall: Medical History- Yes (Chronic renal failure) | 27 Participants | — |
| Relevant Medical History Overall: Medical History- Yes (Diabetes mellitus) | 112 Participants | — |
| Relevant Medical History Overall: Medical History- Yes (Dyslipidemia) | 241 Participants | — |
| Relevant Medical History Overall: Medical History- Yes (History of neoplasm) | 78 Participants | — |
| Relevant Medical History Overall: Medical History- Yes (Ischemic heart disease) | 53 Participants | — |
| Relevant Medical History Overall: Medical History- Yes (Metabolic syndrome) | 2 Participants | — |
| Relevant Medical History Overall: Medical History- Yes (Pneumonias in the last year) | 36 Participants | — |
| Relevant Medical History PCV 13 Population: No | 13 Participants | — |
| Relevant Medical History PCV 13 Population: Yes | 101 Participants | — |
| Relevant Medical History PCV 13 Population: Yes (Arterial hypertension) | 56 Participants | — |
| Relevant Medical History PCV 13 Population: Yes (Cardiac failure) | 2 Participants | — |
| Relevant Medical History PCV 13 Population: Yes (Chronic renal failure) | 1 Participants | — |
| Relevant Medical History PCV 13 Population: Yes (Diabetes mellitus) | 23 Participants | — |
| Relevant Medical History PCV 13 Population: Yes (Dyslipidemia) | 53 Participants | — |
| Relevant Medical History PCV 13 Population: Yes (History of neoplasm) | 13 Participants | — |
| Relevant Medical History PCV 13 Population: Yes (Ischemic heart disease) | 11 Participants | — |
| Relevant Medical History PCV 13 Population: Yes (Pneumonias in the last year) | 9 Participants | — |
| Relevant Medical History Without Pneumococcal Vaccination: No | 12 Participants | — |
| Relevant Medical History Without Pneumococcal Vaccination: Yes | 114 Participants | — |
| Relevant Medical History Without Pneumococcal Vaccination: Yes (Arterial hypertension) | 60 Participants | — |
| Relevant Medical History Without Pneumococcal Vaccination: Yes (Cardiac failure) | 11 Participants | — |
| Relevant Medical History Without Pneumococcal Vaccination: Yes (Chronic renal failure) | 1 Participants | — |
| Relevant Medical History Without Pneumococcal Vaccination: Yes (Diabetes mellitus) | 27 Participants | — |
| Relevant Medical History Without Pneumococcal Vaccination: Yes (Dyslipidemia) | 53 Participants | — |
| Relevant Medical History Without Pneumococcal Vaccination: Yes (History of neoplasm) | 10 Participants | — |
| Relevant Medical History Without Pneumococcal Vaccination: Yes (Ischemic heart disease) | 6 Participants | — |
| Relevant Medical History Without Pneumococcal Vaccination: Yes (Metabolic syndrome) | 0 Participants | — |
| Relevant Medical History Without Pneumococcal Vaccination: Yes (Pneumonias in the last year) | 9 Participants | — |
| Relevant Medical History With Pneumococcal Vaccination: (Chronic renal failure) | 26 Participants | — |
| Relevant Medical History With Pneumococcal Vaccination: (Metabolic syndrome) | 2 Participants | — |
| Relevant Medical History With Pneumococcal Vaccination: No | 27 Participants | — |
| Relevant Medical History With Pneumococcal Vaccination: Yes | 377 Participants | — |
| Relevant Medical History With Pneumococcal Vaccination: Yes (Arterial hypertension) | 219 Participants | — |
| Relevant Medical History With Pneumococcal Vaccination: Yes (Cardiac failure) | 26 Participants | — |
| Relevant Medical History With Pneumococcal Vaccination: Yes (Diabetes mellitus) | 85 Participants | — |
| Relevant Medical History With Pneumococcal Vaccination: Yes (Dyslipidemia) | 188 Participants | — |
| Relevant Medical History With Pneumococcal Vaccination: Yes (History of neoplasm) | 68 Participants | — |
| Relevant Medical History With Pneumococcal Vaccination: Yes (Ischemic heart disease) | 47 Participants | — |
| Relevant Medical History With Pneumococcal Vaccination: Yes (Pneumonias in the last year) | 27 Participants | — |
| Sex: Female, Male Overall Female | 133 Participants | — |
| Sex: Female, Male Overall Male | 397 Participants | — |
| Sex: Female, Male PCV13 Population Female | 26 Participants | — |
| Sex: Female, Male PCV13 Population Male | 88 Participants | — |
| Sex: Female, Male Without pneumococcal vaccination Female | 42 Participants | — |
| Sex: Female, Male Without pneumococcal vaccination Male | 84 Participants | — |
| Sex: Female, Male With pneumococcal vaccination Female | 91 Participants | — |
| Sex: Female, Male With pneumococcal vaccination Male | 313 Participants | — |
| Smoking habit Overall Former smoker | 408 Participants | — |
| Smoking habit Overall Non-smoker | 6 Participants | — |
| Smoking habit Overall Occasional smoker | 18 Participants | — |
| Smoking habit Overall Regular smoker | 98 Participants | — |
| Smoking habit PCV13 Population Former smoker | 84 Participants | — |
| Smoking habit PCV13 Population Non-smoker | 2 Participants | — |
| Smoking habit PCV13 Population Occasional smoker | 3 Participants | — |
| Smoking habit PCV13 Population Regular smoker | 25 Participants | — |
| Smoking habit Without Pneumococcal Vaccination Former smoker | 78 Participants | — |
| Smoking habit Without Pneumococcal Vaccination Non-smoker | 0 Participants | — |
| Smoking habit Without Pneumococcal Vaccination Occasional smoker | 7 Participants | — |
| Smoking habit Without Pneumococcal Vaccination Regular smoker | 41 Participants | — |
| Smoking habit With Pneumococcal Vaccination Former smoker | 330 Participants | — |
| Smoking habit With Pneumococcal Vaccination Non-smoker | 6 Participants | — |
| Smoking habit With Pneumococcal Vaccination Occasional smoker | 11 Participants | — |
| Smoking habit With Pneumococcal Vaccination Regular smoker | 57 Participants | — |
| Waist circumference Overall | 98.4 Centimeters STANDARD_DEVIATION 16.4 | — |
| Waist circumference PCV13 Population | 100.1 Centimeters STANDARD_DEVIATION 17 | — |
| Waist circumference Without pneumococcal vaccination | 99.1 Centimeters STANDARD_DEVIATION 17.5 | — |
| Waist circumference With pneumococcal vaccination | 98.2 Centimeters STANDARD_DEVIATION 16.1 | — |
| Weight Overall | 75.0 Kilogram STANDARD_DEVIATION 16.1 | — |
| Weight PCV13 Population | 75.2 Kilogram STANDARD_DEVIATION 14.1 | — |
| Weight Without pneumococcal vaccination | 74.1 Kilogram STANDARD_DEVIATION 18.9 | — |
| Weight With pneumococcal vaccination | 75.2 Kilogram STANDARD_DEVIATION 15.1 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 39 / 530 |
| other Total, other adverse events | 10 / 530 |
| serious Total, serious adverse events | 78 / 530 |
Outcome results
Primary
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
Population: PCV13 population included evaluable participants who were administered PCV13 at least 1 month prior providing informed consent to participate in the study and who did not subsequently received PPSV23. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With COPD | Change in Adjusted Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV 13 Population | -1.1 Exacerbation per participant in 24 month | Standard Deviation 2.5 |
Primary
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
Population: PCV13 population included evaluable participants who were administered PCV13 at least 1 month prior providing informed consent to participate in the study and who did not subsequently received PPSV23. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With COPD | Change in Adjusted Rate of Moderate/Severe Exacerbations by COPD Severity at Month 24 in PCV13 Population | Grade 1: Mild/unknown | -1.5 Exacerbation per participant in 24 month | Standard Deviation 0.9 |
| Participants With COPD | Change in Adjusted Rate of Moderate/Severe Exacerbations by COPD Severity at Month 24 in PCV13 Population | Grade >1: Moderate to Very Severe | -1.1 Exacerbation per participant in 24 month | Standard Deviation 2.6 |
Secondary
Change From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population
To evaluate the impact of vaccination with PCV13 on patients quality of life ,CAT questionnaire is used. It is used to measure the impact COPD on the participant's wellbeing and daily life and severity of symptoms. The CAT has 8 questions, with score ranging from 0 to 5 for each question, where 0 = no impairment and 5=severe impairment. Total score was calculated as the sum of scores of individual questions and ranged from 0 to 40 with higher scores indicating more severe disease.
Time frame: Baseline, Month 12 and 24
Population: PCV13 population included evaluable participants who were administered PCV13 at least 1 month prior providing informed consent to participate in the study and who did not subsequently received PPSV23. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With COPD | Change From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population | Baseline | 15.5 Units on a scale | Standard Deviation 7.5 |
| Participants With COPD | Change From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population | Change at Month 12 | -1.7 Units on a scale | Standard Deviation 6.3 |
| Participants With COPD | Change From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population | Change at Month 24 | -1.8 Units on a scale | Standard Deviation 6.1 |
Secondary
Change From Baseline in Forced Expiratory Volume (FEV1) at Month 24 in PCV13 Population
To evaluate the impact of vaccination with PCV13 on the decrease of FEV1 was evaluated. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Time frame: Baseline, Month 24
Population: PCV13 population included evaluable participants who were administered PCV13 at least 1 month prior providing informed consent to participate in the study and who did not subsequently received PPSV23. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With COPD | Change From Baseline in Forced Expiratory Volume (FEV1) at Month 24 in PCV13 Population | Baseline | 51.9 Percentage | Standard Deviation 19 |
| Participants With COPD | Change From Baseline in Forced Expiratory Volume (FEV1) at Month 24 in PCV13 Population | Change at Month 24 | -1.7 Percentage | Standard Deviation 10.9 |
Secondary
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
Population: PCV13 population included evaluable participants who were administered PCV13 at least 1 month prior providing informed consent to participate in the study and who did not subsequently received PPSV23. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With COPD | Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population | Baseline: QOL | 45.7 Units on a scale | Standard Deviation 15.4 |
| Participants With COPD | Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population | Change at Month 12: QOL | -5.6 Units on a scale | Standard Deviation 17.4 |
| Participants With COPD | Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population | Change at Month 24: QOL | -6.0 Units on a scale | Standard Deviation 13.8 |
| Participants With COPD | Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population | Baseline: Symptoms | 47.4 Units on a scale | Standard Deviation 18.9 |
| Participants With COPD | Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population | Change at Month 12: Symptoms | -9.0 Units on a scale | Standard Deviation 26.2 |
| Participants With COPD | Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population | Change at Month 24: Symptoms | -16.3 Units on a scale | Standard Deviation 23.4 |
| Participants With COPD | Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population | Baseline: Activity | 56.3 Units on a scale | Standard Deviation 21.2 |
| Participants With COPD | Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population | Change at Month 12: Activity | -4.6 Units on a scale | Standard Deviation 19.9 |
| Participants With COPD | Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population | Change at Month 24: Activity | -4.2 Units on a scale | Standard Deviation 17.3 |
| Participants With COPD | Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population | Baseline: Impacts | 39.7 Units on a scale | Standard Deviation 15.4 |
| Participants With COPD | Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population | Change at Month 12: Impacts | -5.6 Units on a scale | Standard Deviation 19.1 |
| Participants With COPD | Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population | Change at Month 24: Impacts | -6.5 Units on a scale | Standard Deviation 15.5 |
Secondary
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.
Time frame: Month 24
Population: PCV13 population included evaluable participants who were administered PCV13 at least 1 month prior providing informed consent to participate in the study and who did not subsequently received PPSV23. All participants reported under Overall Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With COPD | Change in Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV13 Population by History of Influenza Vaccination | Influenza vaccination: No | -0.7 Exacerbation per participant in 24 month | Standard Deviation 2.2 |
| Participants With COPD | Change in Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV13 Population by History of Influenza Vaccination | Influenza vaccination: Yes | -1.2 Exacerbation per participant in 24 month | Standard Deviation 2.6 |
Secondary
Percentage of Participants With COPD Vaccinated With PCV13
Percentage of evaluable study participants vaccinated with PCV13 prior or after inclusion in the study.
Time frame: Up to Month 24
Population: Evaluable Population according to inclusion criteria (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). The participants were administered PCV13 at least 2 years before or after giving informed consent
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With COPD | Percentage of Participants With COPD Vaccinated With PCV13 | 46.8 Percentage of Participants |
Other Pre-specified
Mean Cost Saving Per COPD Participant With PCV13
Overall cost of hospitalization and/or treatment of exacerbation episode based on days of hospitalization or Intensive care unit and treatment received were planned to be analyzed in this outcome measure.
Time frame: Up to Month 24
Population: PCV13 population included evaluable participants that were administered PCV13 at least 1 month prior providing informed consent to participate in the study and that did not subsequently received PPSV23.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With COPD | Mean Cost Saving Per COPD Participant With PCV13 | NA Euro per participant per year |