Immunization To Prevent Acute COPD Exacerbations

Overview

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

Full Title of Study: “IMMUNIZATION TO PREVENT ACUTE COPD EXACERBATIONS (IMPACE STUDY)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 30, 2019

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.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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 Measures

  • 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).
  • 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.
  • 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
  • Percentage of participants vaccinated with PCV13
    • Time Frame: 2 years
    • Percentage of participants vaccinated with PCV13
  • Change in number of COPD exacerbations/patient/year
    • Time Frame: 2 years
    • Total number of exacerbations reported by participant / follow up time
  • 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer
  • Overall Contact(s)
    • Pfizer CT.gov Call Center, 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com

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