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Immunization To Prevent Acute COPD Exacerbations

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NCT03276754

Last updated on November 6, 2019
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FOR MORE INFORMATION
Study Location
Hospital Universitario Fundacion Alcorcon
Alcorcon, Madrid, 28922 Spain
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections, COPD
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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)

NCT03276754
Pfizer
Not yet recruiting
Immunization To Prevent Acute COPD Exacerbations

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Pfizer Clinical Trials Contact Center

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Descriptive Information
Brief TitleImmunization To Prevent Acute COPD Exacerbations
Official TitleIMMUNIZATION TO PREVENT ACUTE COPD EXACERBATIONS (IMPACE STUDY)
Brief SummaryProspective 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 DescriptionPatients 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 TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationSubjects ?18 years diagnosed with COPD, followed up at the Pulmonology Department of the partipant centres
Condition
  • Pneumococcal Infections
  • COPD
InterventionNot Provided
Study Groups/CohortsNot Provided
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusRecruiting
Estimated Enrollment
 (submitted: September 6, 2017)		1540
Original Estimated EnrollmentSame as current
Estimated Study Completion DateDecember 17, 2021
Estimated Primary Completion DateSeptember 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location CountriesSpain
Removed Location Countries  
 
Administrative Information
NCT NumberNCT03276754
Other Study ID NumbersB1851177
IMPACE ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description: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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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