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Immunization To Prevent Acute COPD Exacerbations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03276754
Recruitment Status : Terminated (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)
First Posted : September 8, 2017
Last Update Posted : April 27, 2023
Information provided by (Responsible Party):

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

Condition or disease
Pneumococcal Infections COPD

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.

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Study Type : Observational
Actual Enrollment : 517 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : November 30, 2017
Actual Primary Completion Date : June 16, 2022
Actual Study Completion Date : June 16, 2022

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in Incidence of moderate or severe COPD exacerbations [ Time Frame: 2 years ]

    Total number of COPD exacerbations reported by participant / follow up time.

    Moderate COPD exacerbation: those that require antibiotics and/or systemic corticosteroids without hospitalization.

    Severe COPD exacerbation: those that lead to hospitalization

  2. COPD severity [ Time Frame: 2 years ]

    COPD severity classification (GOLD):

    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% o FEV1< 50% plus respiratory failure,FEV1/FVC < 0,7])

Secondary Outcome Measures :
  1. Change from baseline in Saint George Respiratory Questionnaire Score [ Time Frame: 2 years ]

    The SGRQ is a specific questionnaire developed to measure health status (quality of life) in patients with chronic airflow limitation.

    Scores are calculated for three domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status).

  2. Change in CAT (COPD Assessment Tool) questionnaire score [ Time Frame: 2 years ]
    COPD Assessment Tool is a simple questionnaire that may be used to determine the severity of symptoms. Scores on CAT range from 0-40 with the higher the score, the more severe the disease.

  3. Change in FEV1 from baseline [ Time Frame: 2 years ]
    FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed as routine clinical practice

  4. Percentage of participants vaccinated with PCV13 [ Time Frame: 2 years ]
    Percentage of participants vaccinated with PCV13

  5. Change in number of COPD exacerbations/patient/year [ Time Frame: 2 years ]
    Total number of exacerbations reported by participant / follow up time

  6. Mean cost per participant [ Time Frame: 2 years ]
    Overall cost of hospitalization and/or treatment of exacerbation episode based on days of hospitalization /ICU and treatment received.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects ≥18 years diagnosed with COPD, followed up at the Pulmonology Department of the partipant centres

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03276754

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Hospital Universitario Mutua Terrassa
Terrassa, Barcelona, Spain, 08221
Hospital Universitario Son Espases
Palma, Islas Baleares, Spain, 07120
Hospital el Bierzo
Ponferrada, León, Spain, 24404
Hospital Universitario Fundacion Alcorcon
Alcorcon, Madrid, Spain, 28922
Hospital Clinico de Barcelona
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 8041
Hospital Universitario de Burgos
Burgos, Spain, 09006
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Hospital Gregorio Marañon
Madrid, Spain, 28007
Hospital Clinico San Carlos
Madrid, Spain, 28040
Complejo Asistencial de Salamanca
Salamanca, Spain, 37007
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT03276754    
Other Study ID Numbers: B1851177
IMPACE ( Other Identifier: Alias Study Number )
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: April 27, 2023
Last Verified: April 2023
Individual Participant Data (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:
Keywords provided by Pfizer:
Pneumococcal infections
COPD exacerbations
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses