Immunization To Prevent Acute COPD Exacerbations

COPD Clinical Trial

Official title:

IMMUNIZATION TO PREVENT ACUTE COPD EXACERBATIONS (IMPACE STUDY)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03276754
• Other study ID #: B1851177
• Secondary ID: IMPACE
• Status: Terminated
• Start date: November 30, 2017
• Est. completion date: June 16, 2022

Study information

• Verified date: April 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 517
• Est. completion date: June 16, 2022
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COPD
• Pneumococcal Infections

Locations

Country	Name	City	State
Spain	Hospital Universitario Fundacion Alcorcon	Alcorcon	Madrid
Spain	Hospital Clinico de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Gregorio Marañon	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Son Espases	Palma	Islas Baleares
Spain	Hospital el Bierzo	Ponferrada	León
Spain	Complejo Asistencial de Salamanca	Salamanca
Spain	Hospital Universitario Mutua Terrassa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Percentage of participants vaccinated with PCV13	Percentage of participants vaccinated with PCV13	2 years
Secondary	Change in number of COPD exacerbations/patient/year	Total number of exacerbations reported by participant / follow up time	2 years
Secondary	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

External Links

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