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Immunization To Prevent Acute COPD Exacerbations

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NCT03276754

Last updated on June 6, 2018
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FOR MORE INFORMATION
Study Location
Hospital Universitario Son Espases
Palma, Islas Baleares, 07120 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
Recruiting
Immunization To Prevent Acute COPD Exacerbations

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Pfizer Clinical Trials Contact Center

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[email protected]

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Immunization To Prevent Acute COPD Exacerbations
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
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Subjects ?18 years diagnosed with COPD, followed up at the Pulmonology Department of the partipant centres
  • Pneumococcal Infections
  • COPD
Not Provided
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
1540
December 17, 2021
September 30, 2019   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Spain
 
 
NCT03276754
B1851177
IMPACE ( Other Identifier: Alias Study Number )
No
Not Provided
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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