Study identifier:RO-2455-401-KR
ClinicalTrials.gov identifier:NCT01419379
EudraCT identifier:N/A
CTIS identifier:N/A
Epidemiologic review and prospective observation of COPD and health in Korea
COPD
-
No
-
All
1114
Observational
40 Years +
Allocation: -
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Nov 2016 by AstraZeneca
AstraZeneca
-
This study is planned to evaluate 2 years of exacerbation in COPD patients and to investigate correlation of COPD disease progress and its exacerbation.
This study was designed as a multicenter, prospective and retrospective and descriptive epidemiology study.This study consisted of 6 months of patient enrollment, 12 months of retrospective study, and 12 months of prospective study. Hence, each patient will be participating in the study for 12 months, while the actual data collections from the patients will take a total of 24 months. The statistical analysis of this study will be done twice, at the completion of 1 year retrospective data collection and at the completion of next 1 year follow-up.
Location
Location
Seoul, Republic of Korea
Location
Gyeongbuk, Republic of Korea
Location
Gyeonggi-do, Republic of Korea
Location
Busan, Republic of Korea
Location
Incheon, Republic of Korea
Location
Gangwon-do, Republic of Korea
Location
Daejon, Republic of Korea
Location
Daegu, Republic of Korea
Arms | Assigned Interventions |
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Chronic obstructive pulmonary disease Participants with chronic obstructive pulmonary disease (COPD) | - |
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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Participants took part in the study at 47 hospitals in in South Korea from 20 July 2011 to 16 January 2013. |
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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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. |
Description | |
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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. |
Stage I COPD | Stage II COPD | Stage III COPD | Stage IV COPD | |
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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 |
Description | |
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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. |
Stage I COPD | Stage II COPD | Stage III COPD | Stage IV COPD | Total | |
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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] |
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< 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] |
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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] |
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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] |
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Chronic Bronchitis | 58 | 163 | 73 | 6 | 300 |
Pulmonary Emphysema | 63 | 248 | 151 | 34 | 496 |
Chronic Bronchitis & Pulmonary Emphysema | 56 | 155 | 82 | 25 | 318 |
Measure Type | Primary |
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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 |
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. |
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All enrolled participants |
Description | |
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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. |
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] |
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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 |
Measure Type | Secondary |
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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 |
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. |
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All enrolled participants with available data |
Description | |
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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. |
Retrospective Exacerbations | No Retrospective Exacerbations | Prospective Exacerbations | No Prospective Exacerbations | |
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Number of
Participants Analyzed [units:participants] |
396 | 718 | 315 | 605 |
Number of Participants with comorbidities of COPD according to COPD exacerbation occurrence [units: participants] |
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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 |
Measure Type | Secondary |
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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 |
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 |
Description | |
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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. |
Exacerbations | No Exacerbations | |
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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) |
Measure Type | Secondary |
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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 |
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. |
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All enrolled participants with available data |
Description | |
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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. |
Exacerbations | No Exacerbations | |
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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) |
Measure Type | Secondary |
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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 |
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. |
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All enrolled participants with available data |
Description | |
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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. |
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) |
Measure Type | Secondary |
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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 |
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 |
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. |
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) |
Measure Type | Secondary |
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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 |
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. |
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All enrolled participants with available data |
Description | |
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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. |
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) |
Measure Type | Secondary |
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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 |
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. |
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All enrolled participants with available data |
Description | |
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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 |
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) |
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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) |
Measure Type | Secondary |
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Measure Name | Number of Participants using inhalant medications for COPD treatment |
Measure Description | |
Time Frame | At 12 months |
Safety Issue? | No |
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 |
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. |
Exacerbations | No Exacerbations | |
---|---|---|
Number of
Participants Analyzed [units:participants] |
315 | 605 |
Number of Participants using inhalant medications for COPD treatment [units: participants] |
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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 |
Measure Type | Secondary |
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Measure Name | Number of Participants who died according to COPD Stage |
Measure Description | |
Time Frame | 12 months |
Safety Issue? | No |
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 |
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. |
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 |
Time Frame | No text entered. |
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Additional Description | Adverse events were not collected in this non-interventional study. |
Description | |
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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. |
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 |
Time Frame | No text entered. |
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Additional Description | Adverse events were not collected in this non-interventional study. |
Threshold above which other adverse events are reported | 0% |
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Description | |
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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. |
Stage I COPD | Stage II COPD | Stage III COPD | Stage IV COPD | |
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Total, other (not including serious) adverse events | ||||
# participants affected / at risk | 0/0 | 0/0 | 0/0 | 0/0 |
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:
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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 |
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No text entered. |
Name/Title: | AstraZeneca Clinical Study Information Center |
Organization: | AstraZeneca |
Phone | 1-877-240-9479 |
E-mail: | [email protected] |
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