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

Study Overview

• Status: Terminated
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 517

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 8041
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08036
    • Hospital Clínico de Barcelona
  • Burgos, Spain, 09006
    • Hospital Universitario de Burgos
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28007
    • Hospital Gregorio Marañon
  • Salamanca, Spain, 37007
    • Complejo Asistencial de Salamanca
  • Barcelona
    • Terrassa, Barcelona, Spain, 08221
      • Hospital Universitario Mutua Terrassa
  • Islas Baleares
    • Palma, Islas Baleares, Spain, 07120
      • Hospital Universitario Son Espases
  • León
    • Ponferrada, León, Spain, 24404
      • Hospital El Bierzo
  • Madrid
    • Alcorcon, Madrid, Spain, 28922
      • Hospital Universitario Fundacion ALcorcon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Incidence of moderate or severe COPD exacerbations	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 years
COPD severity	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])	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Saint George Respiratory Questionnaire Score	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 years
Change in CAT (COPD Assessment Tool) questionnaire score	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.	2 years
Change in FEV1 from baseline	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	2 years
Percentage of participants vaccinated with PCV13	Percentage of participants vaccinated with PCV13	2 years
Change in number of COPD exacerbations/patient/year	Total number of exacerbations reported by participant / follow up time	2 years
Mean cost per participant	Overall cost of hospitalization and/or treatment of exacerbation episode based on days of hospitalization /ICU and treatment received.	2 years

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): June 16, 2022
• Study Completion (Actual): June 16, 2022

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: COPD exacerbations; Pneumococcal infections
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections
• Other Study ID Numbers: B1851177; IMPACE (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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/data_requests.