Pneumococcal InfectionsNCT03276754
Immunization To Prevent Acute COPD Exacerbations
An observational study of Pneumococcal Infections and COPD, run by Pfizer at 11 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumococcal Infections, COPD
- How many people
- 530 participants
- Where
- 11 sitesSpain
- Study dates
- 30 Nov 2017to 16 Jun 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects ≥18 years diagnosed with COPD, followed up at the Pulmonology Department of the partipant centres
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, 28922
Hospital Clinico de Barcelona
Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, 8041
Hospital Universitario de Burgos
Burgos, 09006
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Gregorio Marañon
Madrid, 28007
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario Son Espases
Palma, Balearic Islands, 07120
Hospital el Bierzo
Ponferrada, LEÓN, 24404
Complejo Asistencial de Salamanca
Salamanca, 37007
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, 08221
About this study
Official title: IMMUNIZATION TO PREVENT ACUTE COPD EXACERBATIONS (IMPACE STUDY)
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
Read the 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.
- Conditions
- Pneumococcal Infections, COPD
- Keywords
- Pneumococcal infections, COPD exacerbations
- Medical subject headings
- Pneumococcal Infections, Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and Month 24
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start30 Nov 2017
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276754
- Sponsor's protocol ID
- B1851177
- Other IDs
- IMPACE
- Status last verified
- Aug 2024
- First submitted
- 6 Sep 2017
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMMUNIZATION TO PREVENT ACUTE COPD EXACERBATIONS (IMPACE STUDY)
- ClinicalTrials.gov ID
- NCT03276754
- Acronym / sponsor ID
- B1851177
- Conditions
- Pneumococcal Infections, COPD
- Keywords
- Pneumococcal infections, COPD exacerbations
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: 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
- Enrolment
- 530 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Posted 19 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects ≥18 years diagnosed with COPD, followed up at the Pulmonology Department of the partipant centres
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Adjusted Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV 13 Population
Time frame: 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.
Change in Adjusted Rate of Moderate/Severe Exacerbations by COPD Severity at Month 24 in PCV13 Population
Time frame: 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.
5 secondary outcomes
Change in Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV13 Population by History of Influenza Vaccination
Time frame: Month 24
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
Time frame: Baseline, Month 12 and 24
Change From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population
Time frame: Baseline, Month 12 and 24
Change From Baseline in Forced Expiratory Volume (FEV1) at Month 24 in PCV13 Population
Time frame: Baseline, Month 24
Percentage of Participants With COPD Vaccinated With PCV13
Time frame: Up to Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Infections and COPD, run by Pfizer at 11 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adjusted Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV 13 Population (time frame: Baseline and Month 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024; AzTrials last refreshed its copy on 26 Oct 2026.