Exacerbations and Their Outcomes International (EXACOS International)

Chronic Obstructive Pulmonary Disease Clinical Trial

— EXACOS-Intl  

Official title:

Exacerbations and Their Outcomes International (EXACOS International): Understanding Burden of Severe Exacerbations of COPD and Association Between Frequency of Severe Exacerbations Clinical and Health-care Utilization Outcomes in Less Well-resourced Countries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04928417
• Other study ID #: D5980R00042
• Status: Completed
• Start date: November 26, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: October 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Observational, cross-sectional study with retrospective data collection from medical records. During the cross-sectional study visit, data will be captured through the use of electronic Case Report Forms (eCRFs). As there will be only one study visit, no prospective data collection will take place, nor collection of data that are not part of the routine clinic visit. For understanding the burden of severe exacerbations of COPD and the association between frequency of severe exacerbations and clinical and health-care utilization outcomes in less well-resourced countries

Description:

Observational, cross-sectional study with retrospective data collection from medical records. During the cross-sectional study visit, data will be captured through the use of electronic Case Report Forms (eCRFs). As there will be only one study visit, no prospective data collection will take place, nor collection of data that are not part of the routine clinic visit. For understanding the burden of severe exacerbations of COPD and the association between frequency of severe exacerbations and clinical and health-care utilization outcomes in less well-resourced countries Patients, treated by pulmonologists, with an investigator-confirmed diagnosis of COPD for at least 5 years from the index date (the date that signed Informed Consent was obtained) and who meet all of the inclusion and none of the exclusion criteria

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1762
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patients will be included if they meet the following inclusion criteria:

1. have an investigator-confirmed diagnosis of COPD of at least 5 years and are over the age of 40 years old;

2. are smokers or ex-smokers (quit smoking no longer than 15 years before the study visit);

3. have COPD-related data recorded in (electronic) medical records for at least 5 years, including spirometry and medication data;

4. have signed a written Informed Consent Form

Exclusion Criteria:

• Patients will be excluded from participation if they meet any of the following

exclusion criteria:

1. have a diagnosis of bronchiectasis, sarcoidosis, Interstitial Lung Diseases, or Idiopathic pulmonary fibrosis. This is because differentiating deteriorations in symptoms/exacerbations in these individuals at attributing them to COPD is impossible

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Chile	Research Site	Santiago
Mexico	Research Site	Guadalajara
Mexico	Research Site	Puebla
Russian Federation	Research Site	Blagoveshensk	Russia
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Omsk
Russian Federation	Research Site	Petrozavodsk
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Voronezh
Taiwan	Research Site	Changhua City
Taiwan	Research Site	Kaohsiung City
Taiwan	Research Site	New Taipei City
Taiwan	Research Site	Taichung City
Taiwan	Research Site	Taichung City
Taiwan	Research Site	Taipei City
Taiwan	Research Site	Taipei City
Taiwan	Research Site	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Chile,  Mexico,  Russian Federation,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the frequency of severe Acute exacerbation of COPD, in a COPD population	Number of severe Acute exacerbation of COPD events and interval between severe AECOPDs over the past 5 years	5 YEAR
Primary	c) To describe lung function decline over time (FEV1)	At least 2 (Forced expiratory volume in 1 second)FEV1 measurements at least 6 months apart	5 YEAR
Primary	Health care resource utilization in AECOPD	Number of hospitalizations due to AECOPD in 60 months prior to study visit and time between hospitalizations	5 YEARS
Secondary	Modified Medical Research Council (mMRC) dyspnea scale measured at time of the visit	Modified Medical Research Council (mMRC) dyspnea questionnaire to asses the grade as follow: Grade 0: I only get breathless with strenuous exercise; Grade 1: I get short of breath when hurrying on the level or walking up a slight hill; Grade 2: I walk slower than people of the same age on the level because of breathlessness, or I have to stop for breath when walking on my own pace on the level; Grade 3: I stop for breath after walking about 100 meters or after a few minutes on the level; Grade 4: I am too breathless to leave the house or I am breathless when dressing or undressing	1 YEAR

External Links

•   EXACOS_CSR_Synopsis_Final_03Oct2023.pdf