Clinical trial NCT03276754: Immunization To Prevent Acute COPD Exacerbations
Official title: IMMUNIZATION TO PREVENT ACUTE COPD EXACERBATIONS (IMPACE STUDY)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pneumococcal Infections
COPD
Keywords: Pneumococcal infections
COPD exacerbations
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-09-08
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects ≥18 years diagnosed with COPD, followed up at the Pulmonology Department of the partipant centres

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

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.

Eligibility 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)

Primary outcomes:
measure: Change in Adjusted Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV 13 Population
timeFrame: Baseline and Month 24
measure: Change in Adjusted Rate of Moderate/Severe Exacerbations by COPD Severity at Month 24 in PCV13 Population
timeFrame: Baseline and Month 24
Secondary outcomes:
measure: Change in Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV13 Population by History of Influenza Vaccination
timeFrame: Month 24
measure: Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
timeFrame: Baseline, Month 12 and 24
measure: Change From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population
timeFrame: Baseline, Month 12 and 24
measure: Change From Baseline in Forced Expiratory Volume (FEV1) at Month 24 in PCV13 Population
timeFrame: Baseline, Month 24
measure: Percentage of Participants With COPD Vaccinated With PCV13
timeFrame: Up to Month 24
Other outcomes:
measure: Mean Cost Saving Per COPD Participant With PCV13
timeFrame: Up to Month 24
Locations:
city: Terrassa
country: Spain
facility: Hospital Universitari Mutua Terrassa
state: Barcelona
city: Palma
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Ponferrada
country: Spain
facility: Hospital el Bierzo
state: León
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clinico de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Salamanca
country: Spain
facility: Complejo Asistencial de Salamanca
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: