NCT03276754

Immunization To Prevent Acute COPD Exacerbations

Terminated Results posted Last updated 19 August 2024

What this trial tests

trial in Pneumococcal Infections in 530 participants. Terminated before completion.

Timeline

30 November 2017

Primary endpoint
16 June 2022

16 June 2022

Quick facts

Lead sponsor	Pfizer
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	530
Start date	30 November 2017
Primary completion	16 June 2022
Estimated completion	16 June 2022
Sites	11 locations across Spain

Conditions studied

• Pneumococcal Infections — all drugs for Pneumococcal Infections →
• COPD — all drugs for COPD →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Pneumococcal Infections or COPD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Adjusted Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV 13 Population Primary · 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.

Group	Value	95% CI
Participants With COPD	-1.1	± 2.5

Change in Adjusted Rate of Moderate/Severe Exacerbations by COPD Severity at Month 24 in PCV13 Population Primary · 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 exacerbati

Grade 1: Mild/unknown

Group	Value	95% CI
Participants With COPD	-1.5	± 0.9

Grade >1: Moderate to Very Severe

Group	Value	95% CI
Participants With COPD	-1.1	± 2.6

Change in Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV13 Population by History of Influenza Vaccination Secondary · 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.

Influenza vaccination: No

Group	Value	95% CI
Participants With COPD	-0.7	± 2.2

Influenza vaccination: Yes

Group	Value	95% CI
Participants With COPD	-1.2	± 2.6

Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population Secondary · 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 activi

Baseline: QOL

Group	Value	95% CI
Participants With COPD	45.7	± 15.4

Change at Month 12: QOL

Group	Value	95% CI
Participants With COPD	-5.6	± 17.4

Change at Month 24: QOL

Group	Value	95% CI
Participants With COPD	-6.0	± 13.8

Baseline: Symptoms

Group	Value	95% CI
Participants With COPD	47.4	± 18.9

Change at Month 12: Symptoms

Group	Value	95% CI
Participants With COPD	-9.0	± 26.2

Change at Month 24: Symptoms

Group	Value	95% CI
Participants With COPD	-16.3	± 23.4

Baseline: Activity

Group	Value	95% CI
Participants With COPD	56.3	± 21.2

Change at Month 12: Activity

Group	Value	95% CI
Participants With COPD	-4.6	± 19.9

Change From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population Secondary · 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.

Baseline

Group	Value	95% CI
Participants With COPD	15.5	± 7.5

Change at Month 12

Group	Value	95% CI
Participants With COPD	-1.7	± 6.3

Change at Month 24

Group	Value	95% CI
Participants With COPD	-1.8	± 6.1

Change From Baseline in Forced Expiratory Volume (FEV1) at Month 24 in PCV13 Population Secondary · 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.

Baseline

Group	Value	95% CI
Participants With COPD	51.9	± 19.0

Change at Month 24

Group	Value	95% CI
Participants With COPD	-1.7	± 10.9

Percentage of Participants With COPD Vaccinated With PCV13 Secondary · Up to Month 24

Percentage of evaluable study participants vaccinated with PCV13 prior or after inclusion in the study.

Group	Value	95% CI
Participants With COPD	46.8

Mean Cost Saving Per COPD Participant With PCV13 Secondary · Up to Month 24

Overall cost of hospitalization and/or treatment of exacerbation episode based on days of hospitalization or Intensive care unit and treatment received were planned to be analyzed in this outcome measure.

Group	Value	95% CI
Participants With COPD	NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 24 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Participants With COPD

Serious: 78/530 (15%)

Deaths: 39/530

Serious adverse events (49 terms)

Reaction	System	Participants With COPD
Pneumonia	Infections and infestations	—
COVID-19 pneumonia	Infections and infestations	—
Death	General disorders	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—
Cardio-respiratory arrest	Cardiac disorders	—
Cardiac failure	Cardiac disorders	—
COVID-19	Infections and infestations	—
Acute myocardial infarction	Cardiac disorders	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—
Abdominal sepsis	Infections and infestations	—
Appendicitis perforated	Infections and infestations	—
Cellulitis	Infections and infestations	—
Clostridium difficile colitis	Infections and infestations	—
Klebsiella bacteraemia	Infections and infestations	—
Osteomyelitis	Infections and infestations	—
Peritonitis bacterial	Infections and infestations	—
Pneumonia staphylococcal	Infections and infestations	—
Respiratory tract infection	Infections and infestations	—
Sepsis	Infections and infestations	—
Cardiac failure congestive	Cardiac disorders	—
Supraventricular tachycardia	Cardiac disorders	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—
Pulmonary thrombosis	Respiratory, thoracic and mediastinal disorders	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Sudden death	General disorders	—

Other adverse events (10 terms — click to expand)

Reaction	System	Participants With COPD
Chest pain	General disorders	—
Local reaction	General disorders	—
Vaccination site reaction	General disorders	—
COVID-19	Infections and infestations	—
COVID-19 pneumonia	Infections and infestations	—
Tachyarrhythmia	Cardiac disorders	—
Immunosuppression	Immune system disorders	—
Procedural pneumothorax	Injury, poisoning and procedural complications	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—
Pulmonary resection	Surgical and medical procedures	—

Most-reported serious reactions: Pneumonia, COVID-19 pneumonia, Death, Chronic obstructive pulmonary disease, Cardio-respiratory arrest, Cardiac failure, COVID-19, Acute myocardial infarction.

Data from ClinicalTrials.gov NCT03276754 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.