Immunization To Prevent Acute COPD Exacerbations

• ClinicalTrials.gov Identifier: NCT03276754
• Recruitment Status: Terminated
• First Posted: September 8, 2017
• Last Update Posted: April 27, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 517 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: IMMUNIZATION TO PREVENT ACUTE COPD EXACERBATIONS (IMPACE STUDY)
• Actual Study Start Date: November 30, 2017
• Actual Primary Completion Date: June 16, 2022
• Actual Study Completion Date: June 16, 2022

Groups and Cohorts

Outcome Measures

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.

Eligibility Criteria

• 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

Criteria

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)

Contacts and Locations

Locations

Spain

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

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03276754
• Other Study ID Numbers: B1851177; IMPACE ( Other Identifier: Alias Study Number )
• First Posted: September 8, 2017
• 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: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Keywords provided by Pfizer:

Pneumococcal infections; COPD exacerbations

Additional relevant MeSH terms:

Pneumococcal Infections; Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses