Immunization To Prevent Acute COPD Exacerbations

Terminated

Conditions: Pneumococcal Infections
COPD

Registration Number: NCT03276754

Lead Sponsor: Pfizer

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 530

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Adjusted Rate of Moderate/Severe Exacerbations by COPD Severity at Month 24 in PCV13 Population	Baseline and Month 24	Moderate exacerbations were those that required antibiotics and/or systemic corticosteroids without hospitalization. Severe exacerbations were those that lead to hospitalization. COPD severity was graded as per GOLD criteria. 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% or FEV1\< 50% plus respiratory failure, FEV1/FVC \< 0.7). Adjusted rate of exacerbation was calculated as (total no. of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months. Change in adjusted rate of moderate/severe exacerbations by COPD severity (Grade 1 and Grade \>1) at Month 24 is reported.
Change in Adjusted Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV 13 Population	Baseline and Month 24	COPD exacerbations were defined as a complex of two or more respiratory symptoms (worsening dyspnea, cough, sputum production, chest tightness, or wheezing) related to the underlying COPD, with duration of 3 days or more, that required a change in treatment. Moderate exacerbations were those that required antibiotics and/or systemic corticosteroids without hospitalization. Severe exacerbations were those that lead to hospitalization. Adjusted rate of exacerbation was calculated as (Total number of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population	Baseline, Month 12 and 24	To evaluate the impact of vaccination with PCV13 on patients quality of life SGRQ form was used. It is a self-administered questionnaire developed to measure health status (quality of life) in participants with chronic airflow limitation. The SGRQ consisted of 50 items, where 10 of them were multiple choice and 40 were true or false. Scores were calculated for three domains: Symptoms (eight items; including cough, sputum production, dyspnea or shortness of breath or breathlessness and wheezing, as well as duration, frequency and severity); Activity (16 true or false questions; refers to activities that are limited due to dyspnea);Impacts (26 items; referred to other situations or aspects related to social or psychological functioning affected by the respiratory problems that may alter the participants lifestyle). The total score and scores for each domain ranged from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status).
Change From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population	Baseline, Month 12 and 24	To evaluate the impact of vaccination with PCV13 on patients quality of life ,CAT questionnaire is used. It is used to measure the impact COPD on the participant's wellbeing and daily life and severity of symptoms. The CAT has 8 questions, with score ranging from 0 to 5 for each question, where 0 = no impairment and 5=severe impairment. Total score was calculated as the sum of scores of individual questions and ranged from 0 to 40 with higher scores indicating more severe disease.
Change in Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV13 Population by History of Influenza Vaccination	Month 24	Evaluate the impact of influenza and PCV13 vaccination on the reduction of COPD exacerbations. Adjusted rate of exacerbation was calculated as (total number of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months. Change in rate of moderate/severe exacerbations with and without history of influenza vaccination is presented in this outcome measure.
Change From Baseline in Forced Expiratory Volume (FEV1) at Month 24 in PCV13 Population	Baseline, Month 24	To evaluate the impact of vaccination with PCV13 on the decrease of FEV1 was evaluated. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
Percentage of Participants With COPD Vaccinated With PCV13	Up to Month 24	Percentage of evaluable study participants vaccinated with PCV13 prior or after inclusion in the study.

Trial Locations

Locations (11): Hospital Universitario Son Espases
🇪🇸
Palma, Islas Baleares, Spain
Hospital el Bierzo
🇪🇸
Ponferrada, León, Spain
Hospital Gregorio Marañon
🇪🇸
Madrid, Spain
Hospital Universitari Mutua Terrassa
🇪🇸
Terrassa, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸
Barcelona, Spain
Hospital Universitario Fundacion Alcorcon
🇪🇸
Alcorcon, Madrid, Spain
Hospital Clinico de Barcelona
🇪🇸
Barcelona, Spain
Hospital Universitario de Burgos
🇪🇸
Burgos, Spain
Hospital Clinico San Carlos
🇪🇸
Madrid, Spain
Hospital Universitario de La Princesa
🇪🇸
Madrid, Spain
Complejo Asistencial de Salamanca
🇪🇸
Salamanca, Spain