ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Adult Trials: 18+ Years
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)
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)
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Immunization To Prevent Acute COPD Exacerbations | ||||
| Official Title | IMMUNIZATION TO PREVENT ACUTE COPD EXACERBATIONS (IMPACE STUDY) | ||||
| 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. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Subjects ?18 years diagnosed with COPD, followed up at the Pulmonology Department of the partipant centres | ||||
| Condition |
| ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment | 1540 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 30, 2022 | ||||
| Estimated Primary Completion Date | December 30, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion criteria:
Exclusion criteria:
| ||||
| Sex/Gender |
| ||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Spain | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03276754 | ||||
| Other Study ID Numbers | B1851177 IMPACE ( Other Identifier: Alias Study Number ) | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | April 2021 | ||||