EXACOS-Intl: Exacerbations and Their Outcomes International (EXACOS International)

Sponsor

AstraZeneca (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04928417

Collaborator

(none)

3,000

Enrollment

Locations

10.1

Anticipated Duration (Months)

142.9

Patients Per Site

14.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

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

Actual Study Start Date :

Nov 26, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Outcome Measures

Primary Outcome Measures

Estimate the frequency of severe Acute exacerbation of COPD, in a COPD population [5 YEAR]
Number of severe Acute exacerbation of COPD events and interval between severe AECOPDs over the past 5 years
c) To describe lung function decline over time (FEV1) [5 YEAR]
At least 2 (Forced expiratory volume in 1 second)FEV1 measurements at least 6 months apart
Health care resource utilization in AECOPD [5 YEARS]
Number of hospitalizations due to AECOPD in 60 months prior to study visit and time between hospitalizations

Secondary Outcome Measures

Modified Medical Research Council (mMRC) dyspnea scale measured at time of the visit [1 YEAR]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

have an investigator-confirmed diagnosis of COPD of at least 5 years and are over the age of 40 years old;
are smokers or ex-smokers (quit smoking no longer than 15 years before the study visit);
have COPD-related data recorded in (electronic) medical records for at least 5 years, including spirometry and medication data;
have signed a written Informed Consent Form

Exclusion Criteria:

Patients will be excluded from participation if they meet any of the following exclusion criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Santiago		Chile	7580023
2	Research Site	Guadalajara		Mexico	44670
3	Research Site	Puebla		Mexico	72450
4	Research Site	Blagoveshensk	Russia	Russian Federation	675000
5	Research Site	Chelyabinsk		Russian Federation	454021
6	Research Site	Ekaterinburg		Russian Federation	620109
7	Research Site	Krasnoyarsk		Russian Federation	660037
8	Research Site	Moscow		Russian Federation	119991
9	Research Site	Omsk		Russian Federation	644005
10	Research Site	Petrozavodsk		Russian Federation	185019
11	Research Site	Saint-Petersburg		Russian Federation	196247
12	Research Site	Saint-Petersburg		Russian Federation	199106
13	Research Site	Voronezh		Russian Federation	394066
14	Research Site	Changhua City		Taiwan	50006
15	Research Site	Kaohsiung City		Taiwan	80756
16	Research Site	New Taipei City		Taiwan	220
17	Research Site	Taichung City		Taiwan	404332
18	Research Site	Taichung City		Taiwan	40705
19	Research Site	Taipei City		Taiwan	100225
20	Research Site	Taipei City		Taiwan	11217
21	Research Site	Taoyuan City		Taiwan	333

Sponsors and Collaborators

AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT04928417

Other Study ID Numbers:

D5980R00042

First Posted:

Jun 16, 2021

Last Update Posted:

Aug 10, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by AstraZeneca

Chronic obstructive pulmonary disease

COPD

Additional relevant MeSH terms:

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Aug 10, 2022