Immunization To Prevent Acute COPD Exacerbations

• Register: ClinicalTrials.gov
• Last refreshed on: 8 May 2023
• Main ID: NCT03276754
• Date of registration: 06/09/2017
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Immunization To Prevent Acute COPD Exacerbations
• Scientific title: IMMUNIZATION TO PREVENT ACUTE COPD EXACERBATIONS (IMPACE STUDY)
• Date of first enrolment: November 30, 2017
• Target sample size: 517
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03276754
• Study type: Observational

Countries of recruitment

Spain

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

COPD

Pneumococcal Infections

Primary Outcome(s)

Change in Incidence of moderate or severe COPD exacerbations [Time Frame: 2 years]

COPD severity [Time Frame: 2 years]

Secondary Outcome(s)

Change in CAT (COPD Assessment Tool) questionnaire score [Time Frame: 2 years]

Mean cost per participant [Time Frame: 2 years]

Change from baseline in Saint George Respiratory Questionnaire Score [Time Frame: 2 years]

Change in number of COPD exacerbations/patient/year [Time Frame: 2 years]

Change in FEV1 from baseline [Time Frame: 2 years]

Percentage of participants vaccinated with PCV13 [Time Frame: 2 years]

Secondary ID(s)

B1851177

IMPACE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors