Status:
TERMINATED
Immunization To Prevent Acute COPD Exacerbations
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Infections
COPD
Eligibility:
All Genders
18+ years
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 exacerba...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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)
- Exclusion criteria:
- 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)
Exclusion
Key Trial Info
Start Date :
November 30 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 16 2022
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT03276754
Start Date
November 30 2017
End Date
June 16 2022
Last Update
August 19 2024
Active Locations (11)
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1
Hospital Universitario Son Espases
Palma, Balearic Islands, Spain, 07120
2
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain, 08221
3
Hospital el Bierzo
Ponferrada, LEÓN, Spain, 24404
4
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, Spain, 28922