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| ID | Type | Description | Link |
|---|---|---|---|
| IMPACE | Other Identifier | Alias Study Number |
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The study was terminated prematurely due to the inability to recruit the planned number of subjects and the interim analysis indicated that the number of included patients did not allow draw any valid conclusion about the main objective of the study
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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
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline and Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Month 24 |
Inclusion criteria:
Exclusion criteria:
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Subjects ≥18 years diagnosed with COPD, followed up at the Pulmonology Department of the partipant centres
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Son Espases | Palma | Balearic Islands | 07120 | Spain | ||
| Hospital Universitari Mutua Terrassa |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 530 evaluable participants were included in the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis population included all evaluable participants whose data were included and prospectively observed in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Exacerbation per participant in 24 month | Baseline and Month 24 |
|
Up to 24 months
Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | Non-systematic Assessment |
Several limitations related to the study, such as lack of data about relevant confounding factors, and a lower than expected sample size, which makes impossible the adjustment of analyses by relevant confounding factors such as age, presence and number of comorbidities, severity of the disease, etc, make difficult to discard that the changes in the exacerbation rates are due to other causes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 31, 2016 | Aug 12, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2017 | Aug 12, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Month 24 |
| 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). | Baseline, Month 12 and 24 |
| 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. | Baseline, Month 12 and 24 |
| 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. | Baseline, Month 24 |
| Percentage of Participants With COPD Vaccinated With PCV13 | Percentage of evaluable study participants vaccinated with PCV13 prior or after inclusion in the study. | Up to Month 24 |
| Terrassa |
| Barcelona |
| 08221 |
| Spain |
| Hospital el Bierzo | Ponferrada | LEÓN | 24404 | Spain |
| Hospital Universitario Fundacion Alcorcon | Alcorcón | Madrid | 28922 | Spain |
| Hospital Clinico de Barcelona | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 8041 | Spain |
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Complejo Asistencial de Salamanca | Salamanca | 37007 | Spain |
| No data reported at Month 24 |
|
| Death |
|
Number Analyzed signifies number of participants evaluable for the specified rows. |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Weight | Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Mean | Standard Deviation | Kilogram |
|
| Height | Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Mean | Standard Deviation | Centimeters |
|
| Body Mass Index | BMI was calculated automatically based on the reported weight and height in the unit of kilograms over squared meters (kg/m^2). Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Mean | Standard Deviation | Kilograms per meter square |
|
| Waist circumference | Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Mean | Standard Deviation | Centimeters |
|
| Relevant Medical History | The participants were reported with the medical history of Yes/No. In case of "Yes" medical history, the following comorbidities were reported: arterial hypertension, dyslipidemia, diabetes mellitus, history of neoplasm, ischemic heart disease, pneumonias in the last year, cardiac failure, chronic renal failure and metabolic syndromes. Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Count of Participants | Participants |
|
| Smoking habit | The participants were classified as regular smoker (currently smokes tobacco daily), occasional smoker (does not smoke daily), non-smoker (has not been exposed to smoking) and former smoker (has quit smoking more than 6 months ago). Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Count of Participants | Participants |
|
| Alcohol consumption | The participants were reported with consumption of alcohol as Yes/No. The intake of at least 80 gram/day in the previous year is considered as Yes. Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Count of Participants | Participants |
|
| Forced Expiratory Volume (FEV1) | FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. It is expressed as volume (in milliliters) and is considered normal when it is greater than 80 percent (%) of its theoretical value. Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Mean | Standard Deviation | Percentage |
|
| Forced Vital Capacity (FVC) | FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. It is expressed as volume (in ml) and is considered normal when it is greater than 80% of its theoretical value. Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Mean | Standard Deviation | Percentage |
|
| FEV1/FVC Ratio | FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Mean | Standard Deviation | Percentage |
|
| COPD severity (GOLD) | COPD severity in terms Global Initiative for Chronic Obstructive Lung Disease (GOLD) is defined as follows: Grade 1: Mild/unknown (FEV1 greater than equal to [>=]80%, FEV1/FVC Less than [< 0.7] or no spirometry data); Grade 2: Moderate (50% less than equal to [<=] FEV1< 80%,FEV1/FVC < 0.7); Grade 3: Severe (30% <= FEV1 < 50%, FEV1/FVC < 0.7) and Grade 4: Very severe (FEV1< 30% FEV1< 50% plus respiratory failure,FEV1/FVC < 0.7). Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Count of Participants | Participants |
|
| Number of moderate/severe exacerbations prior to study inclusion | Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Mean | Standard Deviation | Exacerbation per participant in 24 month |
|
| Pneumococcal vaccination prior to study inclusion | The Participants were classified as No (Without pneumococcal vaccination) and Yes (With pneumococcal vaccination). If Yes, then according to the type of pneumococcal vaccination received as: Polysaccharide only (PPSV23 [23 valent pneumococcal polysaccharide vaccine ]), Polysaccharide (PPSV23) + Conjugate (PCV13) and Conjugate only (PCV13). Overall number of participants, with pneumococcal vaccination and without pneumococcal vaccination is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Count of Participants | Participants |
|
| Conjugate pneumococcal vaccination (PCV13) prior to study inclusion | Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Count of Participants | Participants |
|
| History of influenza vaccination | Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Count of Participants | Participants |
|
| Most frequent treatments for COPD at baseline | The participants were classified as Yes/No according to pharmacological treatment received for COPD. In the table below, the following have been abbreviated as: Long-Acting Muscarinic Antagonist(LAMA), Long-Acting Beta Agonist(LABA), Inhaled corticosteroid (IC), Short-acting Beta Agonist(SABA), Short Acting Muscarinic Antagonist(SAMA); Phosphodiesterase 4 (PDE4) and N-acetylcysteine(NAC). Overall number of participants, with pneumococcal vaccination, without pneumococcal vaccination and PCV13 population is presented. | Number Analyzed signifies number of participants evaluable for the specified rows. | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | 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. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Exacerbation per participant in 24 month | Baseline and Month 24 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Exacerbation per participant in 24 month | Month 24 |
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 12 and 24 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Month 12 and 24 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Percentage | Baseline, Month 24 |
|
|
|
| Secondary | Percentage of Participants With COPD Vaccinated With PCV13 | Percentage of evaluable study participants vaccinated with PCV13 prior or after inclusion in the study. | 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 | Posted | Number | Percentage of Participants | Up to Month 24 |
|
|
|
| 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. | 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. | Posted | Number | Euro per participant per year | Up to Month 24 |
|
|
|
| 39 |
| 530 |
| 78 |
| 530 |
| 10 |
| 530 |
| COVID-19 pneumonia | Infections and infestations | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Abdominal sepsis | Infections and infestations | Non-systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | Non-systematic Assessment |
|
| Klebsiella bacteraemia | Infections and infestations | Non-systematic Assessment |
|
| Osteomyelitis | Infections and infestations | Non-systematic Assessment |
|
| Peritonitis bacterial | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Death | General disorders | Non-systematic Assessment |
|
| Sudden death | General disorders | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | Non-systematic Assessment |
|
| Guillain-Barre syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | Non-systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | Non-systematic Assessment |
|
| Shock | Vascular disorders | Non-systematic Assessment |
|
| Bicytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Lung operation | Surgical and medical procedures | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Local reaction | General disorders | Non-systematic Assessment |
|
| Vaccination site reaction | General disorders | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | Non-systematic Assessment |
|
| Immunosuppression | Immune system disorders | Non-systematic Assessment |
|
| Procedural pneumothorax | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary resection | Surgical and medical procedures | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D007239 | Infections |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Former smoker |
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| Former smoker |
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| Former smoker |
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| Grade 4: Very severe |
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| Grade 4: Very severe |
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| Grade 4: Very severe |
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| Change at Month 24: QOL |
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| Baseline: Symptoms |
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| Change at Month 12: Symptoms |
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| Change at Month 24: Symptoms |
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| Baseline: Activity |
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| Change at Month 12: Activity |
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| Change at Month 24: Activity |
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| Baseline: Impacts |
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| Change at Month 12: Impacts |
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| Change at Month 24: Impacts |
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| Change at Month 24 |
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