Immunization To Prevent Acute COPD Exacerbations

NCT03276754

Last updated date
Study Location
Hospital Universitario Mutua Terrassa
Terrassa, Barcelona, 08221, Spain
Contact
1-800-718-1021

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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)

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Pneumococcal Infections, COPDImmunization To Prevent Acute COPD Exacerbations
NCT03276754
  1. Terrassa, Barcelona
  2. Ponferrada, León
  3. Barcelona,
  4. Madrid,
  5. Palma, Islas Baleares
  6. Alcorcon, Madrid
  7. Barcelona,
  8. Burgos,
  9. Madrid,
  10. Madrid,
  11. Salamanca,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Immunization To Prevent Acute COPD Exacerbations
Official Title IMMUNIZATION TO PREVENT ACUTE COPD EXACERBATIONS (IMPACE STUDY)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Subjects ?18 years diagnosed with COPD, followed up at the Pulmonology Department of the partipant centres
Condition
  • Pneumococcal Infections
  • COPD
Intervention Not Provided
Study Groups/Cohorts Not 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 Status Recruiting
Estimated Enrollment
 (submitted: September 6, 2017)
1540
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2022
Estimated Primary Completion Date December 30, 2022   (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
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03276754
Other Study ID Numbers B1851177
IMPACE ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not 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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2020