COPDCOPDCAPNCT03046134
Burden of Hospitalized Pneumonia in Korea COPD Population
An observational study of COPD and Pneumonia, run by Chung-Ang University Hospital at 4 sites in South Korea.
Trial summary
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality worldwide. By 2030, COPD is expected to be the fourth main cause of death. Community-acquired pneumonia (CAP) represents not only a frequent complication but also a deadly cause in COPD patients. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Pneumonia, Pneumococcal Vaccine
- What is being tested?
- PCV13
- Type of treatment
- Vaccines
- How many people
- 384 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 3 Mar 2017to Feb 2019
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: COPD patients hospitalized for community-acquired pneumonia
Who may be able to join
- Currently smoking male or female over 40 years.
- Smoking history ≥ 10 pack-years.
- Post bronchodilator (BD) FEV1/FVC <70% and post BD FEV1 < 80% of predicted.
- Newly developed pneumonic infiltrates (lobar-, broncho-, or interstitial-pattern) on chest radiography (taken after the development of respiratory symptoms) with at least 2 of following 3 criteria
- Body temperature (<36℃ or ≥ 38.0℃)
- White blood cell count (<5,000/mm3 or >10,000/mm3)
- Cough and/or sputum
Who cannot join
- Chest radiologic abnormalities (taken before the development of pneumonia) which explain the obstructive pattern in pulmonary function.
- Current diagnosis of bronchial asthma.
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Bundang Hospital
Bundang, Gyeonggi-do, 13620
Young Jae Cho, M.D.
- Recruiting
Seoul National University
Seoul, 03080
Chang Hoon Lee, M.D., 010-9563-2310, kauri670@empal.com
- Recruiting
Asan Medical Center
Seoul, 05505
Yeon-Mok Oh, M.D., 010-6824-3136, ymoh55@amc.seoul.kr
- Recruiting
Seoul National University Boramae Medical Center
Seoul, 07061
Deog Kyeom Kim, M.D., 010-4691-1355, kimdkmd@snu.ac.kr
About this study
Official title: Burden of Hospitalized Pneumonia and Its Clinical Characteristics in Korea COPD Population: A Prospective, Multi-center, Cohort Study
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality worldwide. By 2030, COPD is expected to be the fourth main cause of death. Community-acquired pneumonia (CAP) represents not only a frequent complication but also a deadly cause in COPD patients. Inhaled corticosteroids, which are frequently used among COPD patients increase the risk for pneumonia. The effect of pneumococcal conjugate vaccine 13 (PCV13) on the prevention of pneumococcal pneumonia among COPD patients in Korean population has not been studied yet.
Several factors such as multi-lobar pneumonia, Pseudomonas aeruginosa pneumonia, and high pneumonia severity are related to poor outcome of patients with COPD and pneumonia. Prior pneumococcal vaccine has a beneficial effect on outcomes of pneumonia with COPD patients. However, the effects of pneumococcal vaccine on the clinical outcome of COPD patients were evaluated mainly on 23-valent pneumococcal polysaccharide vaccine (PPV23). The beneficial effects of PPV23 rapidly fade out after inoculation, which is more prominent in old age group. In this sense, PPV23 vaccine is not sufficient in preventing pneumococcal diseases in COPD patients because COPD is the disease of old ages and mortality rate increases exponentially with advancing age. Pneumococcal conjugate vaccine 13 (PCV13) can overcome the waning phenomenon by the production of memory B cells. Although PCV13 is expected to be the best option for the prevention of pneumococcal pneumonia in COPD patients, there are few available studies supporting it.
Read more
In this study, we will conduct prospective, multi-center trial with the collaboration of Korean pulmonologists in five university-affiliated hospitals. In this study, we will evaluate influenza and pneumococcal vaccination status, the pathogen distribution, pneumonia severity, and clinical outcomes of hospitalized pneumonia patients with COPD.
If successfully accomplished, this study will enhance the awareness of the preventive use of PCV13 in COPD patients among Korean pulmonologists and, most importantly, it will lead to protection of more COPD patients from pneumococcal pneumonia, one of the most frequent and deadly complication.
Read the detailed description
- Objectives; Prospective evaluation of distribution of pathogens and its clinical characteristics in hospitalized pneumonia patients with COPD
- SUBJECTS AND CENTERS A. Subjects; COPD patients hospitalized for community-acquired pneumonia from Feb, 2017 to Feb, 2018.
- Centers; More than five university-affiliated hospitals of Korea
- OTHER THERAPY; Treatment for COPD with pneumonia will be done by the disposal of attending physicians of each hospital.
- STUDY DESIGN ; prospective, multi-center, cohort study
- STUDY ANALYSIS A. The required number of COPD patients hospitalized for community-acquired pneumonia
- The sample size calculations were based on detecting 1 point difference in CURB-65 score between influenza/pneumococcal vaccine recipients and non-recipients (expecting the mean CURB-65 score of 3 points for influenza/pneumococcal vaccine recipients and 4 points for non-recipients), assuming a common standard deviation of 1 point in each group,* a two-tailed test at 5% type I error, and a desired power of 80%. In terms of PCV 13, the estimated sample size for an independent t-test is 90 when we expect that 10% of them were PCV13 recipients and the other 90% were non-recipients (in Korea, 10% of candidates are estimated to be vaccinated with PCV13). Since the CURB-65 scores may not be symmetrically distributed, adding 15% to the required number was considered for a non-parametric test and the desired number of patients with COPD and pneumococcal pneumonia is 104 for the analysis. Total 384 COPD patients admitted for community-acquired pneumonia will be enrolled, assuming 30% prevalence of pneumococcal pneumonia among them (the prevalence of pneumococcal pneumonia is 25~45% in Korea), with allowance of 10% possible data loss.
- referenced from 'Role of Semi-quantitative Serum Procalcitonin in Assessing Prognosis of Community Acquired Bacterial Pneumonia Compared to PORT PSI, CURB-65 and CRB-65 Journal of Clinical and Diagnostic Research. 2015 Jul, Vol-9(7): OC01-OC04' B. Parameters to be evaluated A) Demographic data . Age, gender, BMI, smoking status, socioeconomic status B) Past medical history . Comorbidities; diabetes, hypertension, malignancy, chronic renal disease, chronic liver disease… . Smoking status and amount of smoking by pack-year . Vaccination status (types and timing)
- Will be checked both by history taking and by the review of medical record
- PCV13, PPV23, Influenza vaccine, Zostavax…. C) Diagnostic tests for the identification of pneumonia pathogens . Sputum Gram stain/culture (adequacy will be evaluated with the Bartlett criteria)
- Sputum PCR test for bacterial pneumonia pathogens
- Multiplex PCR test designed for the detection of S. pneumoniae, M. pneumoniae, L. pneumophila, H. influenza, B. pertussis, C. pneumoniae
- Urine antigen test(Binax and SS-UAD) for pneumococcus - two aliquots of the urine sample will be frozen and stored for subsequent shipment to the central laboratory (Pfizer Vaccines Research East and Early Development, Pearl River, PA, USA) for Luminex platform-based multiplex UAD assay testing as described previously (Pride et al. Clin Vaccine Immunol 2012;19:1131-41). Processing, storing and shipping of urine samples will be carried out according to Pfizer protocol. Urine will be tested locally using the commercially-available BinaxNOW® S. pneumoniae antigen test also.
- Control urine samples will be collected from 400 adults without pneumonia according to the Pfizer urine collecting method and stored for subsequent shipment to the central laboratory (Pfizer Vaccines Research East and Early Development, Pearl River, PA, USA) for Luminex platform-based multiplex UAD assay testing.
- Two sets of blood culture D) Severity scores
- Pneumonia severity index (PSI)
- CURB-65 E) Outcome parameters
- ICU admission rate
- Mechanical ventilation rate
- ICU stay and hospital stay
- Mortality
- SAFETY; ; This is an observational study which evaluates the effects of previously inoculated influenza/pneumococcal vaccine. Treatment for pneumonia and COPD will be done by attending physician with their own disposal. In this setting there would not be ethical issues to be debated.
- DECISION POINTS/ STATISTICAL METHODS/INTERIM ANALYSIS ; The statistics will be purely descriptive. Continuous variables will be presented as mean ± SD or median value with minimum and maximum values. Categorical data will be presented as frequency and percentile. Intergroup comparison of continuous variables will be done with student T test and that of categorical data will be done with Chi-square test or with Fisher's exact test. Statistical significance will be determined at the 5% level. We will consider non-parametric equivalent tests if the distributional assumptions are not suitably made.
- DATES; Feb 2017 ~ FEB 2018
- Conditions
- COPD, Pneumonia, Pneumococcal Vaccine
- Being tested
- PCV13
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV13Biological
Conjugated pneumococcal vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
The distribution of pathogens in hospitalized pneumonia patients with COPD
Measured: 1 year
Secondary outcomes (6)
Intensive care unit (ICU) admission rate
Measured: 1 year
Mechanical ventilation rate
Measured: 1 year
The length of ICU stay
Measured: 1 year
The length of hospital stay
Measured: 1 year
Mortality
Measured: 1 year
Age- and gender-matched pneumonia severity
It will be measured by CURB-65 and pneumonia severity index (PSI) in community-acquired pneumonia with COPD
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study start3 Mar 2017
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 384 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Chung-Ang University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, JAE YEOL KIM, Chung-Ang University Hospital
- Investigators
- JAE YEOL KIM, MD, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046134
- Sponsor's protocol ID
- WI221325
- Acronym
- COPDCAP
- Status last verified
- Jul 2017
- First submitted
- 1 Feb 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Centers for Disease Control and Prevention (CDC). Chronic obstructive pulmonary disease among adults--United States, 2011. MMWR Morb Mortal Wkly Rep. 2012 Nov 23;61(46):938-43.
PubMed 23169314Lin SH, Ji BC, Shih YM, Chen CH, Chan PC, Chang YJ, Lin YC, Lin CH. Comorbid pulmonary disease and risk of community-acquired pneumonia in COPD patients. Int J Tuberc Lung Dis. 2013 Dec;17(12):1638-44. doi: 10.5588/ijtld.13.0330.
PubMed 24200282Rinaudo M, Ferrer M, Terraneo S, De Rosa F, Peralta R, Fernandez-Barat L, Li Bassi G, Torres A. Impact of COPD in the outcome of ICU-acquired pneumonia with and without previous intubation. Chest. 2015 Jun;147(6):1530-1538. doi: 10.1378/chest.14-2005.
PubMed 25612147Suissa S, Patenaude V, Lapi F, Ernst P. Inhaled corticosteroids in COPD and the risk of serious pneumonia. Thorax. 2013 Nov;68(11):1029-36. doi: 10.1136/thoraxjnl-2012-202872.
PubMed 24130228Hwang YI, Lee SH, Yoo JH, Jung BH, Yoo KH, Na MJ, Lee JD, Park MJ, Jung CY, Shim JJ, Kim KC, Kim YJ, Choi HS, Choi IS, Lee CT, Lee SD, Kim DJ, Uh ST, Lee HS, Kim YS, Lee KH, Ra SW, Kim HR, Choi SJ, Park IW, Park YB, Park SY, Lee J, Jung KS. History of pneumonia is a strong risk factor for chronic obstructive pulmonary disease (COPD) exacerbation in South Korea: the Epidemiologic review and Prospective Observation of COPD and Health in Korea (EPOCH) study. J Thorac Dis. 2015 Dec;7(12):2203-13. doi: 10.3978/j.issn.2072-1439.2015.12.17.
PubMed 26793342Myint PK, Lowe D, Stone RA, Buckingham RJ, Roberts CM. U.K. National COPD Resources and Outcomes Project 2008: patients with chronic obstructive pulmonary disease exacerbations who present with radiological pneumonia have worse outcome compared to those with non-pneumonic chronic obstructive pulmonary disease exacerbations. Respiration. 2011;82(4):320-7. doi: 10.1159/000327203. Epub 2011 May 20.
PubMed 21597277Walters JA, Smith S, Poole P, Granger RH, Wood-Baker R. Injectable vaccines for preventing pneumococcal infection in patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD001390. doi: 10.1002/14651858.CD001390.pub3.
PubMed 21069668Almirall J, Bolibar I, Balanzo X, Gonzalez CA. Risk factors for community-acquired pneumonia in adults: a population-based case-control study. Eur Respir J. 1999 Feb;13(2):349-55. doi: 10.1183/09031936.99.13234999.
PubMed 10065680Lee TA, Weaver FM, Weiss KB. Impact of pneumococcal vaccination on pneumonia rates in patients with COPD and asthma. J Gen Intern Med. 2007 Jan;22(1):62-7. doi: 10.1007/s11606-007-0118-3.
PubMed 17351841Kweon S, Kim Y, Jang MJ, Kim Y, Kim K, Choi S, Chun C, Khang YH, Oh K. Data resource profile: the Korea National Health and Nutrition Examination Survey (KNHANES). Int J Epidemiol. 2014 Feb;43(1):69-77. doi: 10.1093/ije/dyt228.
PubMed 24585853
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Hospitalized Pneumonia and Its Clinical Characteristics in Korea COPD Population: A Prospective, Multi-center, Cohort Study
- ClinicalTrials.gov ID
- NCT03046134
- Acronym / sponsor ID
- COPDCAP / WI221325
- Conditions
- COPD, Pneumonia, Pneumococcal Vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Chung-Ang University HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 8 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality worldwide. By 2030, COPD is expected to be the fourth main cause of death. Community-acquired pneumonia (CAP) represents not only a frequent complication but also a deadly cause in COPD patients. Inhaled corticosteroids, which are frequently used among COPD patients increase the risk for pneumonia. The effect of pneumococcal conjugate vaccine 13 (PCV13) on the prevention of pneumococcal pneumonia among COPD patients in Korean population has not been studied yet.
Several factors such as multi-lobar pneumonia, Pseudomonas aeruginosa pneumonia, and high pneumonia severity are related to poor outcome of patients with COPD and pneumonia. Prior pneumococcal vaccine has a beneficial effect on outcomes of pneumonia with COPD patients. However, the effects of pneumococcal vaccine on the clinical outcome of COPD patients were evaluated mainly on 23-valent pneumococcal polysaccharide vaccine (PPV23). The beneficial effects of PPV23 rapidly fade out after inoculation, which is more prominent in old age group. In this sense, PPV23 vaccine is not sufficient in preventing pneumococcal diseases in COPD patients because COPD is the disease of old ages and mortality rate increases exponentially with advancing age. Pneumococcal conjugate vaccine 13 (PCV13) can overcome the waning phenomenon by the production of memory B cells. Although PCV13 is expected to be the best option for the prevention of pneumococcal pneumonia in COPD patients, there are few available studies supporting it.
In this study, we will conduct prospective, multi-center trial with the collaboration of Korean pulmonologists in five university-affiliated hospitals. In this study, we will evaluate influenza and pneumococcal vaccination status, the pathogen distribution, pneumonia severity, and clinical outcomes of hospitalized pneumonia patients with COPD.
If successfully accomplished, this study will enhance the awareness of the preventive use of PCV13 in COPD patients among Korean pulmonologists and, most importantly, it will lead to protection of more COPD patients from pneumococcal pneumonia, one of the most frequent and deadly complication.
Detailed description
- Objectives; Prospective evaluation of distribution of pathogens and its clinical characteristics in hospitalized pneumonia patients with COPD
- SUBJECTS AND CENTERS A. Subjects; COPD patients hospitalized for community-acquired pneumonia from Feb, 2017 to Feb, 2018.
- Centers; More than five university-affiliated hospitals of Korea
- OTHER THERAPY; Treatment for COPD with pneumonia will be done by the disposal of attending physicians of each hospital.
- STUDY DESIGN ; prospective, multi-center, cohort study
- STUDY ANALYSIS A. The required number of COPD patients hospitalized for community-acquired pneumonia
- The sample size calculations were based on detecting 1 point difference in CURB-65 score between influenza/pneumococcal vaccine recipients and non-recipients (expecting the mean CURB-65 score of 3 points for influenza/pneumococcal vaccine recipients and 4 points for non-recipients), assuming a common standard deviation of 1 point in each group,* a two-tailed test at 5% type I error, and a desired power of 80%. In terms of PCV 13, the estimated sample size for an independent t-test is 90 when we expect that 10% of them were PCV13 recipients and the other 90% were non-recipients (in Korea, 10% of candidates are estimated to be vaccinated with PCV13). Since the CURB-65 scores may not be symmetrically distributed, adding 15% to the required number was considered for a non-parametric test and the desired number of patients with COPD and pneumococcal pneumonia is 104 for the analysis. Total 384 COPD patients admitted for community-acquired pneumonia will be enrolled, assuming 30% prevalence of pneumococcal pneumonia among them (the prevalence of pneumococcal pneumonia is 25~45% in Korea), with allowance of 10% possible data loss.
- referenced from 'Role of Semi-quantitative Serum Procalcitonin in Assessing Prognosis of Community Acquired Bacterial Pneumonia Compared to PORT PSI, CURB-65 and CRB-65 Journal of Clinical and Diagnostic Research. 2015 Jul, Vol-9(7): OC01-OC04' B. Parameters to be evaluated A) Demographic data . Age, gender, BMI, smoking status, socioeconomic status B) Past medical history . Comorbidities; diabetes, hypertension, malignancy, chronic renal disease, chronic liver disease… . Smoking status and amount of smoking by pack-year . Vaccination status (types and timing)
- Will be checked both by history taking and by the review of medical record
- PCV13, PPV23, Influenza vaccine, Zostavax…. C) Diagnostic tests for the identification of pneumonia pathogens . Sputum Gram stain/culture (adequacy will be evaluated with the Bartlett criteria)
- Sputum PCR test for bacterial pneumonia pathogens
- Multiplex PCR test designed for the detection of S. pneumoniae, M. pneumoniae, L. pneumophila, H. influenza, B. pertussis, C. pneumoniae
- Urine antigen test(Binax and SS-UAD) for pneumococcus - two aliquots of the urine sample will be frozen and stored for subsequent shipment to the central laboratory (Pfizer Vaccines Research East and Early Development, Pearl River, PA, USA) for Luminex platform-based multiplex UAD assay testing as described previously (Pride et al. Clin Vaccine Immunol 2012;19:1131-41). Processing, storing and shipping of urine samples will be carried out according to Pfizer protocol. Urine will be tested locally using the commercially-available BinaxNOW® S. pneumoniae antigen test also.
- Control urine samples will be collected from 400 adults without pneumonia according to the Pfizer urine collecting method and stored for subsequent shipment to the central laboratory (Pfizer Vaccines Research East and Early Development, Pearl River, PA, USA) for Luminex platform-based multiplex UAD assay testing.
- Two sets of blood culture D) Severity scores
- Pneumonia severity index (PSI)
- CURB-65 E) Outcome parameters
- ICU admission rate
- Mechanical ventilation rate
- ICU stay and hospital stay
- Mortality
- SAFETY; ; This is an observational study which evaluates the effects of previously inoculated influenza/pneumococcal vaccine. Treatment for pneumonia and COPD will be done by attending physician with their own disposal. In this setting there would not be ethical issues to be debated.
- DECISION POINTS/ STATISTICAL METHODS/INTERIM ANALYSIS ; The statistics will be purely descriptive. Continuous variables will be presented as mean ± SD or median value with minimum and maximum values. Categorical data will be presented as frequency and percentile. Intergroup comparison of continuous variables will be done with student T test and that of categorical data will be done with Chi-square test or with Fisher's exact test. Statistical significance will be determined at the 5% level. We will consider non-parametric equivalent tests if the distributional assumptions are not suitably made.
- DATES; Feb 2017 ~ FEB 2018
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients hospitalized for community-acquired pneumonia
Key inclusion criteria (7 listed)
- Currently smoking male or female over 40 years.
- Smoking history ≥ 10 pack-years.
- Post bronchodilator (BD) FEV1/FVC <70% and post BD FEV1 < 80% of predicted.
- Newly developed pneumonic infiltrates (lobar-, broncho-, or interstitial-pattern) on chest radiography (taken after the development of respiratory symptoms) with at least 2 of following 3 criteria
- Body temperature (<36℃ or ≥ 38.0℃)
Key exclusion criteria (2 listed)
- Chest radiologic abnormalities (taken before the development of pneumonia) which explain the obstructive pattern in pulmonary function.
- Current diagnosis of bronchial asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCV13Conjugated pneumococcal vaccine | Biological | – |
Primary outcome
The distribution of pathogens in hospitalized pneumonia patients with COPD
Time frame: 1 year
6 secondary outcomes
Intensive care unit (ICU) admission rate
Time frame: 1 year
Mechanical ventilation rate
Time frame: 1 year
The length of ICU stay
Time frame: 1 year
The length of hospital stay
Time frame: 1 year
Mortality
Time frame: 1 year
Age- and gender-matched pneumonia severity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Background: PubMed 23169314Centers for Disease Control and Prevention (CDC). Chronic obstructive pulmonary disease among adults--United States, 2011. MMWR Morb Mortal Wkly Rep. 2012 Nov 23;61(46):938-43.
- Background: PubMed 24200282Lin SH, Ji BC, Shih YM, Chen CH, Chan PC, Chang YJ, Lin YC, Lin CH. Comorbid pulmonary disease and risk of community-acquired pneumonia in COPD patients. Int J Tuberc Lung Dis. 2013 Dec;17(12):1638-44. doi: 10.5588/ijtld.13.0330.
- Background: PubMed 25612147Rinaudo M, Ferrer M, Terraneo S, De Rosa F, Peralta R, Fernandez-Barat L, Li Bassi G, Torres A. Impact of COPD in the outcome of ICU-acquired pneumonia with and without previous intubation. Chest. 2015 Jun;147(6):1530-1538. doi: 10.1378/chest.14-2005.
- Background: PubMed 24130228Suissa S, Patenaude V, Lapi F, Ernst P. Inhaled corticosteroids in COPD and the risk of serious pneumonia. Thorax. 2013 Nov;68(11):1029-36. doi: 10.1136/thoraxjnl-2012-202872.
- Background: PubMed 26793342Hwang YI, Lee SH, Yoo JH, Jung BH, Yoo KH, Na MJ, Lee JD, Park MJ, Jung CY, Shim JJ, Kim KC, Kim YJ, Choi HS, Choi IS, Lee CT, Lee SD, Kim DJ, Uh ST, Lee HS, Kim YS, Lee KH, Ra SW, Kim HR, Choi SJ, Park IW, Park YB, Park SY, Lee J, Jung KS. History of pneumonia is a strong risk factor for chronic obstructive pulmonary disease (COPD) exacerbation in South Korea: the Epidemiologic review and Prospective Observation of COPD and Health in Korea (EPOCH) study. J Thorac Dis. 2015 Dec;7(12):2203-13. doi: 10.3978/j.issn.2072-1439.2015.12.17.
- Background: PubMed 21597277Myint PK, Lowe D, Stone RA, Buckingham RJ, Roberts CM. U.K. National COPD Resources and Outcomes Project 2008: patients with chronic obstructive pulmonary disease exacerbations who present with radiological pneumonia have worse outcome compared to those with non-pneumonic chronic obstructive pulmonary disease exacerbations. Respiration. 2011;82(4):320-7. doi: 10.1159/000327203. Epub 2011 May 20.
- Background: PubMed 21069668Walters JA, Smith S, Poole P, Granger RH, Wood-Baker R. Injectable vaccines for preventing pneumococcal infection in patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2010 Nov 10;(11):CD001390. doi: 10.1002/14651858.CD001390.pub3.
- Background: PubMed 10065680Almirall J, Bolibar I, Balanzo X, Gonzalez CA. Risk factors for community-acquired pneumonia in adults: a population-based case-control study. Eur Respir J. 1999 Feb;13(2):349-55. doi: 10.1183/09031936.99.13234999.
- Background: PubMed 17351841Lee TA, Weaver FM, Weiss KB. Impact of pneumococcal vaccination on pneumonia rates in patients with COPD and asthma. J Gen Intern Med. 2007 Jan;22(1):62-7. doi: 10.1007/s11606-007-0118-3.
- Background: PubMed 24585853Kweon S, Kim Y, Jang MJ, Kim Y, Kim K, Choi S, Chun C, Khang YH, Oh K. Data resource profile: the Korea National Health and Nutrition Examination Survey (KNHANES). Int J Epidemiol. 2014 Feb;43(1):69-77. doi: 10.1093/ije/dyt228.
- Individual participant dataSharing planned: No
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JAE YEOL KIM, MD principal investigator
Chung-Ang University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Pneumonia, run by Chung-Ang University Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hye Mi Kil, RN (+82-2-6299-1385, es6013@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distribution of pathogens in hospitalized pneumonia patients with COPD (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03046134, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.