Epidemiology study in patients with Chronic Obstructive Pulmonary Disease (COPD) in Korea - EPOCH

Study identifier:RO-2455-401-KR

ClinicalTrials.gov identifier:NCT01419379

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Epidemiologic review and prospective observation of COPD and health in Korea

Medical condition

COPD

Phase

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

1114

Study type

Observational

Age

40 Years +

Date

Study Start Date: 01 Jul 2011

Primary Completion Date: 01 Jan 2013

Study Completion Date: 01 Jan 2013

Study design

Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Nov 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Nycomed Investigational Site

Seoul, Republic of Korea

Location

Nycomed Investigational Site

Gyeongbuk, Republic of Korea

Location

Nycomed Investigational Site

Gyeonggi-do, Republic of Korea

Location

Nycomed Investigational Site

Busan, Republic of Korea

Location

Nycomed Investigational Site

Incheon, Republic of Korea

Location

Nycomed Investigational Site

Gangwon-do, Republic of Korea

Location

Nycomed Investigational Site

Daejon, Republic of Korea

Location

Nycomed Investigational Site

Daegu, Republic of Korea

Arms	Assigned Interventions
Chronic obstructive pulmonary disease Participants with chronic obstructive pulmonary disease (COPD)	-

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at 47 hospitals in in South Korea from 20 July 2011 to 16 January 2013.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with at least 1 year of medical history of COPD as assessed by the Global Initiative for Chronic Obstructive Lung Diseases (GOLD) criteria were enrolled in this non-interventional study.

Reporting Groups

	Description
Stage I COPD	Participants with Stage I chronic obstructive pulmonary disease (COPD) defined by the Gold criteria as mild airflow limitation (forced expiratory volume in 1 second/forced vital capacity [FEV1/FVC] <70%; FEV1 ≥ 80% predicted) and sometimes, but not always, chronic cough and sputum production.
Stage II COPD	Participants with Stage II COPD defined by the Gold criteria as worsening airflow limitation (FEV1/FVC < 70%; 50% ≤ FEV1 < 80% predicted), with shortness of breath typically developing on exertion.
Stage III COPD	Participants with Stage III COPD defined by the Gold criteria as further worsening of airflow limitation (FEV1/FVC < 70%; 30% ≤ FEV1 <50% predicted), greater shortness of breath, reduced exercise capacity, and repeated exacerbations which have an impact on patients’ quality of life.
Stage IV COPD	Participants with Stage IV COPD defined by the Gold criteria as severe airflow limitation (FEV1/FVC < 70%; FEV1 < 30% predicted) or FEV1 < 50% predicted plus chronic respiratory failure. Patients may have Very Severe (Stage Ⅳ) COPD even if the FEV1 is > 30% predicted, whenever this complication is present.

Participant Flow: Overall Study

	Stage I COPD	Stage II COPD	Stage III COPD	Stage IV COPD
STARTED	177	566	306	65
COMPLETED	135	473	260	52
NOT COMPLETED	42	93	46	13
Withdrawal of consent	6	10	9	0
Lost to Follow-up	32	61	26	8
Other Hospital Transfer	4	17	6	1
Death	0	5	5	4

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Stage I COPD	Participants with Stage I (mild) chronic obstructive pulmonary disease (COPD) defined by the Gold criteria.
Stage II COPD	Participants with Stage II (moderate) COPD defined by the Gold criteria.
Stage III COPD	Participants with Stage III (severe) COPD defined by the Gold criteria.
Stage IV COPD	Participants with Stage IV (very severe) COPD defined by the Gold criteria.

Baseline Measures

	Stage I COPD	Stage II COPD	Stage III COPD	Stage IV COPD	Total
Number of Participants [units: Participants]	177	566	306	65	1114
Age Continuous [units: years] Mean ± Standard Deviation	70.0 ± 7.9	69.8 ± 8.2	68.2 ± 7.9	65.8 ± 8.1	69.3 ± 8.2
Age, Customized [units: participants]
< 60 years	15	70	48	16	149
≥ 60 years and < 70 years	52	192	117	24	385
≥ 70 years and < 80 years	90	246	129	23	488
≥ 80 years	20	58	12	2	92
Gender, Male/Female [units: participants]
Female	18	52	26	3	99
Male	159	514	280	62	1015
Region of Enrollment [units: participants] Korea, Republic Of	177	566	306	65	1114
Body Height [units: cm] Mean ± Standard Deviation	163.2 ± 7.8	163.9 ± 7.3	164.5 ± 7.2	165.4 ± 6.8	164.0 ± 7.3
Body Weight [units: kg] Mean ± Standard Deviation	61.7 ± 10.0	61.1 ± 9.9	58.0 ± 10.1	54.0 ± 10.5	59.9 ± 10.2
Body Mass Index [units: kg/m^2] Mean ± Standard Deviation	23.1 ± 2.9	22.7 ± 3.1	21.5 ± 3.3	19.7 ± 3.3	22.2 ± 3.3
Smoking History [units: participants]
Never Smoked	13	57	30	6	106
Current Smokers	45	126	55	11	237
Former Smokers	119	383	221	48	771
Chronic Obstructive Pulmonary Disease (COPD) Duration [units: years] Mean ± Standard Deviation	5.2 ± 4.9	5.3 ± 4.6	6.6 ± 4.9	7.3 ± 5.1	5.8 ± 4.8
COPD Phenotypes [units: participants]
Chronic Bronchitis	58	163	73	6	300
Pulmonary Emphysema	63	248	151	34	496
Chronic Bronchitis & Pulmonary Emphysema	56	155	82	25	318

Outcome Measures

1. Primary Outcome Measure: Number of participants with a COPD exacerbation during 2 years [ Time Frame: 2 Years (1 year prior to study enrollment and 1 year after enrollment ) ]

Measure Type	Primary
Measure Name	Number of participants with a COPD exacerbation during 2 years
Measure Description	Data summarized from medical records for the year before the enrollment (retrospective phase), and for the year after enrollment (prospective phase). A COPD exacerbation was defined as an event that requires treatments with systemic corticosteroid and/or antibiotics (moderate) or hospitalization (severe). Data are reported by Global Initiative for Chronic Obstructive Lung Diseases (GOLD) criteria stage. Participants may have had more than 1 exacerbation type.
Time Frame	2 Years (1 year prior to study enrollment and 1 year after enrollment )
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants

Reporting Groups

	Description
Stage I COPD	Participants with Stage I (mild) chronic obstructive pulmonary disease (COPD) defined by the Gold criteria.
Stage II COPD	Participants with Stage II (moderate) COPD defined by the Gold criteria.
Stage III COPD	Participants with Stage III (severe) COPD defined by the Gold criteria.
Stage IV COPD	Participants with Stage IV (very severe) COPD defined by the Gold criteria.

Measured Values

	Stage I COPD	Stage II COPD	Stage III COPD	Stage IV COPD
Number of Participants Analyzed [units:participants]	177	566	306	65
Number of participants with a COPD exacerbation during 2 years [units: participants]
Participants with any exacerbation	64	247	175	43
Severe exacerbation	33	153	137	72
Moderate exacerbation	68	327	316	86
Other exacerbation	14	74	67	10

No statistical analysis provided for Number of participants with a COPD exacerbation during 2 years

2. Secondary Outcome Measure: Number of Participants with comorbidities of COPD according to COPD exacerbation occurrence [ Time Frame: At enrollment and after 12 months ]

Measure Type	Secondary
Measure Name	Number of Participants with comorbidities of COPD according to COPD exacerbation occurrence
Measure Description	The number of participants with comorbidities at enrollment are presented for participants with at least one or no COPD exacerbations in the 12 months prior to enrollment (retrospective), and at 12 months for participants with one or more or no exacerbations during the 12 month prospective phase.
Time Frame	At enrollment and after 12 months
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants with available data

Reporting Groups

	Description
Retrospective Exacerbations	Participants with one or more exacerbations in the 12 months prior to enrollment
No Retrospective Exacerbations	Participants with no COPD exacerbations during the 12 months prior to enrollment.
Prospective Exacerbations	Participants with one or more COPD exacerbations in the 12 months after enrollment
No Prospective Exacerbations	Participants with no COPD exacerbations during the 12 months after study enrollment.

Measured Values

	Retrospective Exacerbations	No Retrospective Exacerbations	Prospective Exacerbations	No Prospective Exacerbations
Number of Participants Analyzed [units:participants]	396	718	315	605
Number of Participants with comorbidities of COPD according to COPD exacerbation occurrence [units: participants]
Hypertension	140	264	125	239
Bronchial asthma	71	110	58	103
Benign prostatic hyperplasia	58	80	43	97
Diabetes	51	78	49	69
Coronary artery diseases	46	58	37	68
Pneumonia	111	27	81	13
Pulmonary tuberculosis	15	26	23	28
Cerebrovascular diseases	9	33	14	28
Osteoporosis	17	19	19	16
Depression	10	13	14	18
Hyperlipidemia	11	14	10	16
Atrial fibrillation	8	9	9	13
Others	99	172	86	155
Any Comorbidity	325	532	266	469

No statistical analysis provided for Number of Participants with comorbidities of COPD according to COPD exacerbation occurrence

3. Secondary Outcome Measure: Change from Enrollment to 1 year in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Enrollment and 1 year ]

Measure Type	Secondary
Measure Name	Change from Enrollment to 1 year in Forced Expiratory Volume in 1 Second (FEV1)
Measure Description	FEV1 is the volume of air expired in the first second during maximal expiratory effort.
Time Frame	Enrollment and 1 year
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants with available data

Reporting Groups

	Description
Exacerbations	Participants with one or more COPD exacerbations during the 12 months after study enrollment.
No Exacerbations	Participants with no COPD exacerbations during the 12 months after study enrollment.

Measured Values

	Exacerbations	No Exacerbations
Number of Participants Analyzed [units:participants]	315	605
Change from Enrollment to 1 year in Forced Expiratory Volume in 1 Second (FEV1) [units: liters] Mean (Standard Deviation)	-0.1 (0.3)	-0.1 (0.4)

No statistical analysis provided for Change from Enrollment to 1 year in Forced Expiratory Volume in 1 Second (FEV1)

4. Secondary Outcome Measure: Change from Enrollment to 1 year in Forced Expiratory Volume in 1 Second (FEV1) percent predicted [ Time Frame: Enrollment and 1 year ]

Measure Type	Secondary
Measure Name	Change from Enrollment to 1 year in Forced Expiratory Volume in 1 Second (FEV1) percent predicted
Measure Description	FEV1 is the maximal amount of air that can be forcefully exhaled in one second. It is then converted to a percent of predicted based on the participant's age, sex, race and height.
Time Frame	Enrollment and 1 year
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants with available data

Reporting Groups

	Description
Exacerbations	Participants with one or more COPD exacerbations during the 12 months after study enrollment.
No Exacerbations	Participants with no COPD exacerbations during the 12 months after study enrollment.

Measured Values

	Exacerbations	No Exacerbations
Number of Participants Analyzed [units:participants]	315	605
Change from Enrollment to 1 year in Forced Expiratory Volume in 1 Second (FEV1) percent predicted [units: percent predicted] Mean (Standard Deviation)	-2.0 (14.0)	-2.9 (18.3)

No statistical analysis provided for Change from Enrollment to 1 year in Forced Expiratory Volume in 1 Second (FEV1) percent predicted

5. Secondary Outcome Measure: Change from Enrollment to 1 year in Forced Vital Capacity (FVC) [ Time Frame: Enrollment and 1 year ]

Measure Type	Secondary
Measure Name	Change from Enrollment to 1 year in Forced Vital Capacity (FVC)
Measure Description	Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Time Frame	Enrollment and 1 year
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants with available data

Reporting Groups

	Description
Exacerbations	Participants with one or more COPD exacerbations during the 12 months after study enrollment.
No Exacerbations	Participants with no COPD exacerbations during the 12 months after study enrollment.

Measured Values

	Exacerbations	No Exacerbations
Number of Participants Analyzed [units:participants]	315	605
Change from Enrollment to 1 year in Forced Vital Capacity (FVC) [units: liters] Mean (Standard Deviation)	-0.1 (0.6)	-0.2 (0.8)

No statistical analysis provided for Change from Enrollment to 1 year in Forced Vital Capacity (FVC)

6. Secondary Outcome Measure: Change from Enrollment to 1 year in Forced Vital Capacity (FVC) percent predicted [ Time Frame: Enrollment and 1 year ]

Measure Type	Secondary
Measure Name	Change from Enrollment to 1 year in Forced Vital Capacity (FVC) percent predicted
Measure Description	Forced vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. It is then converted to a percent of predicted based on the participant's age, sex, race and height.
Time Frame	Enrollment and 1 year
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants with available data

Reporting Groups

	Description
Exacerbations	Participants with one or more COPD exacerbations during the 12 months after study enrollment.
No Exacerbations	Participants with no COPD exacerbations during the 12 months after study enrollment.

Measured Values

	Exacerbations	No Exacerbations
Number of Participants Analyzed [units:participants]	315	605
Change from Enrollment to 1 year in Forced Vital Capacity (FVC) percent predicted [units: percent predicted] Mean (Standard Deviation)	-5.0 (19.1)	-6.5 (23.4)

No statistical analysis provided for Change from Enrollment to 1 year in Forced Vital Capacity (FVC) percent predicted

7. Secondary Outcome Measure: Change from Enrollment to 1 year in FEV1/FVC [ Time Frame: Enrollment and 1 year ]

Measure Type	Secondary
Measure Name	Change from Enrollment to 1 year in FEV1/FVC
Measure Description	FEV1/FVC is the percentage of the vital capacity which is expired in the first second of maximal expiration. In healthy patients the FEV1/FVC is usually around 70%.
Time Frame	Enrollment and 1 year
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants with available data

Reporting Groups

	Description
Exacerbations	Participants with one or more COPD exacerbations during the 12 months after study enrollment.
No Exacerbations	Participants with no COPD exacerbations during the 12 months after study enrollment.

Measured Values

	Exacerbations	No Exacerbations
Number of Participants Analyzed [units:participants]	315	605
Change from Enrollment to 1 year in FEV1/FVC [units: percentage of vital capacity] Mean (Standard Deviation)	0.1 (5.5)	-0.6 (5.2)

No statistical analysis provided for Change from Enrollment to 1 year in FEV1/FVC

8. Secondary Outcome Measure: COPD Assessment Test (CAT) according to COPD exacerbation occurrence [ Time Frame: At enrollment and after 12 months ]

Measure Type	Secondary
Measure Name	COPD Assessment Test (CAT) according to COPD exacerbation occurrence
Measure Description	Participants completed the CAT (COPD Assessment Test) questionnaire at enrollment and after 12 months. The CAT questionnaire measures the impact of COPD on wellbeing and daily life. Participants answer 8 questions on a scale from 0 (best) to 5 (worst). The total score ranges from 0 to 40 with higher scores indicating more impact. Results are reported for participants with and without exacerbations in the 12 months prior to both time points.
Time Frame	At enrollment and after 12 months
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants with available data

Reporting Groups

	Description
Exacerbations	Participants with one or more COPD exacerbations in the 12 months prior to each time point
No Exacerbations	Participants with no COPD exacerbations during the 12 months prior to each time point

Measured Values

	Exacerbations	No Exacerbations
Number of Participants Analyzed [units:participants]	396	717
COPD Assessment Test (CAT) according to COPD exacerbation occurrence [units: units on a scale] Mean (Standard Deviation)
Enrollment (n=396, 717)	19.8 (8.3)	15.4 (8.1)
12 Months (n=314, 605)	19.4 (8.8)	15.1 (8.3)

No statistical analysis provided for COPD Assessment Test (CAT) according to COPD exacerbation occurrence

9. Secondary Outcome Measure: Number of Participants using inhalant medications for COPD treatment [ Time Frame: At 12 months ]

Measure Type	Secondary
Measure Name	Number of Participants using inhalant medications for COPD treatment
Measure Description
Time Frame	At 12 months
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants with available data

Reporting Groups

	Description
Exacerbations	Participants with one or more COPD exacerbations during the 12 months after study enrollment.
No Exacerbations	Participants with no COPD exacerbations during the 12 months after study enrollment.

Measured Values

	Exacerbations	No Exacerbations
Number of Participants Analyzed [units:participants]	315	605
Number of Participants using inhalant medications for COPD treatment [units: participants]
Formoterol and other drugs	89	139
Salmeterol and other drugs	137	195
Fenoterol	1	0
Indacaterol	2	1
Ipratropium bromide	6	3
Tiotropium bromide	260	472
Budesonide	4	2
Ciclesonide	2	11
Fluticasone	1	0
Procaterol	4	4
Salbutamol	85	77

No statistical analysis provided for Number of Participants using inhalant medications for COPD treatment

10. Secondary Outcome Measure: Number of Participants who died according to COPD Stage [ Time Frame: 12 months ]

Measure Type	Secondary
Measure Name	Number of Participants who died according to COPD Stage
Measure Description
Time Frame	12 months
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants with available data

Reporting Groups

	Description
Stage I COPD	Participants with Stage I (mild) chronic obstructive pulmonary disease (COPD) defined by the Gold criteria.
Stage II COPD	Participants with Stage II (moderate) COPD defined by the Gold criteria.
Stage III COPD	Participants with Stage III (severe) COPD defined by the Gold criteria.
Stage IV COPD	Participants with Stage IV (very severe) COPD defined by the Gold criteria.

Measured Values

	Stage I COPD	Stage II COPD	Stage III COPD	Stage IV COPD
Number of Participants Analyzed [units:participants]	176	566	306	65
Number of Participants who died according to COPD Stage [units: participants]	0	5	5	4

No statistical analysis provided for Number of Participants who died according to COPD Stage

Serious Adverse Events

Time Frame	No text entered.
Additional Description	Adverse events were not collected in this non-interventional study.

Reporting Groups

	Description
Stage I COPD	Participants with Stage I (mild) chronic obstructive pulmonary disease (COPD) defined by the Gold criteria.
Stage II COPD	Participants with Stage II (moderate) COPD defined by the Gold criteria.
Stage III COPD	Participants with Stage III (severe) COPD defined by the Gold criteria.
Stage IV COPD	Participants with Stage IV (very severe) COPD defined by the Gold criteria.

Serious Adverse Events

	Stage I COPD	Stage II COPD	Stage III COPD	Stage IV COPD
Total, serious adverse events
# participants affected / at risk	0/0	0/0	0/0	0/0

Other Adverse Events

Time Frame	No text entered.
Additional Description	Adverse events were not collected in this non-interventional study.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Stage I COPD	Participants with Stage I (mild) chronic obstructive pulmonary disease (COPD) defined by the Gold criteria.
Stage II COPD	Participants with Stage II (moderate) COPD defined by the Gold criteria.
Stage III COPD	Participants with Stage III (severe) COPD defined by the Gold criteria.
Stage IV COPD	Participants with Stage IV (very severe) COPD defined by the Gold criteria.

Other Adverse Events

	Stage I COPD	Stage II COPD	Stage III COPD	Stage IV COPD
Total, other (not including serious) adverse events
# participants affected / at risk	0/0	0/0	0/0	0/0

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	AstraZeneca Clinical Study Information Center
Organization:	AstraZeneca
Phone	1-877-240-9479
E-mail:	[email protected]

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

AstraZeneca AstraZeneca

AstraZeneca

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Nycomed Investigational Site

Nycomed Investigational Site

Nycomed Investigational Site

Nycomed Investigational Site

Nycomed Investigational Site

Nycomed Investigational Site

Nycomed Investigational Site

Nycomed Investigational Site

Trial Results Summaries