Immunization To Prevent Acute COPD Exacerbations

NCT03276754 | Terminated Results

• 2 other identifiers: B1851177IMPACE
• Study Type: observational
• Target: 530
• Locations: 1 country
• Sites: 11

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

Conditions

Pneumococcal Infections; COPD

Keywords

Pneumococcal infections; COPD exacerbations

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline and Month 24

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

  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.

  Baseline and Month 24

Secondary Outcomes (5)

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

  Month 24

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

  Baseline, Month 12 and 24

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

  Baseline, Month 12 and 24

• Change From Baseline in Forced Expiratory Volume (FEV1) at Month 24 in PCV13 Population

  Baseline, Month 24

• Percentage of Participants With COPD Vaccinated With PCV13

  Up to Month 24

Other Outcomes (1)

• Mean Cost Saving Per COPD Participant With PCV13

  Up to Month 24

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects ≥18 years diagnosed with COPD, followed up at the Pulmonology Department of the partipant centres

You may qualify if:

• Patient ≥18 years diagnosed with COPD (any stage, the subgroups for the analysis would be based on COPD severity grade)
• Ability to understand and complete the required QoL questionnaires
• 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.
• 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)

You may not qualify if:

• Impossibility to perform prospective follow up
• Present any immunocompromising condition
• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (11)

Hospital Universitario Son Espases

Palma, Balearic Islands, 07120, Spain

Location

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital el Bierzo

Ponferrada, LEÓN, 24404, Spain

Location

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

Hospital Clinico de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 8041, Spain

Location

Hospital Universitario de Burgos

Burgos, 09006, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Complejo Asistencial de Salamanca

Salamanca, 37007, Spain

Location

Related Links

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

MeSH Terms

Conditions

Pneumococcal Infections; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Several limitations related to the study, such as lack of data about relevant confounding factors, and a lower than expected sample size, which makes impossible the adjustment of analyses by relevant confounding factors such as age, presence and number of comorbidities, severity of the disease, etc, make difficult to discard that the changes in the exacerbation rates are due to other causes.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 8, 2017
• Study Start: November 30, 2017
• Primary Completion: June 16, 2022
• Study Completion: June 16, 2022
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (11)