COPDKCOCONCT04200079
Kingston Chronic Obstructive Pulmonary Disease (COPD) Multidimensional Long Term Follow up Cohort
An observational study of COPD and Emphysema, run by Dr. Juan Pablo de Torres Tajes at 1 site in Canada.
Trial summary
Background: Chronic Obstructive Pulmonary (COPD) patients are the paradigm of the chronic complex patient. Their follow up can sometimes be difficult and challenging (1). There are patients with recurrent exacerbations that put an enormous burden on health care resources (2). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jan 2020to 31 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients usually followed at a Respirology clinic
Who may be able to join
- Patients ages between 40-85 years old.
- Smoking history of at least 10 pack year history
- Active of former smokers
- Diagnosis of COPD according to the GOLD definition (4): post bronchodilator spirometry FEV1/FVC ≤0.70, including those with other associated respiratory diseases like asthma, bronchiectasis, stable lung cancer or Interstitial Lung Disease.
- Ability to perform all study procedures (complete pulmonary function tests, six minute walking test (6MWT) and chest computed tomography) and provide/sign informed consent.
Who cannot join
- Patients not willing to sign the consent form
- Patients with a life expectancy of less than 3 yrs.
- Patients in palliative care.
- Patients with chronic airway obstruction ie: FEV1/FVC≤0.70 of other etiology and without a smoking history of less than 10 packs year history.
- Patients unable ort not able to perform the pulmonary function test, the 6MWT or the chest CT.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
KHSC
Kingston, Ontario, K7L2V6
Juan P de Torres, MD, 613 549 6666 ext. 6905, jpdt@queensu.ca
About this study
Official title: Kingston COPD Cohort
Background: Chronic Obstructive Pulmonary (COPD) patients are the paradigm of the chronic complex patient. Their follow up can sometimes be difficult and challenging (1). There are patients with recurrent exacerbations that put an enormous burden on health care resources (2). They also have multiple comorbidities (3) that can sometimes make their management difficult. In an attempt to coordinate all these efforts KGH, HDH and Providence Care have numerous essential resources to take care of COPD patients like the nurse navigators, nurse practitioners and the pulmonary rehabilitation program. These programs provide an excellent support to the clinical activity of Respirologists and other health care providers.
Rationale: The main rationale for the development of the Kingston COPD cohort is to translate that highly demanding clinical activity in a teaching and research oriented activity that could be used by clinicians, medical students, residents and fellows. Having a guideline complained established protocol in COPD patients that are usually follow at KGH and HDH could help in not only in unified the way COPD patients are seeing (preserving the importance of the personalized approach) but most importantly established a multidimensional (clinical, physiological, radiological, laboratory) database. This could help know not only the results of our clinical activity but also have a long term (>5yrs) database for clinical research projects in collaboration with national and international research groups. Therefore this proposal is important because it will help translate our busy daily clinical work in a highly productive teaching and research activity.
Read the detailed description
Aims: establish a long term multidimensional follow up of a large COPD cohort of COPD patients in Kingston, Ontario.
Specific Objectives: 1. established a simple and easy to apply follow up protocol in COPD patients. 2. Hire a research assistant 3. Set up the database.
Data source: Patients included in the present cohort will be those usually follow at the Respirology clinic at Hotel Dieu Hospital in Kingston Ontario.
Data elements: this will include clinical, laboratory, physiological and radiological data.
Clinical: baseline and yearly evaluation. The following information will be collected and registered: Age, gender, history of prematurity and low weight at birth, maternal smoking during pregnancy, history of infections or wheezing during infancy, pack year history: (age of smoking initiation, years smoking, packs per day, age of quitting if quit), active or former smokers, use of vaping or marihuana?, registration of Comorbidities using the Copd cOmorbidiTy indEx COTE index, use of medications: LABA, LAMA, dual, LABA/ICS, ICS, Roflumilast, Erithromycin, NAC, etc, use of O2 at home: lt/min and duration, CPAP and BiPAP and pressures, degree of dyspnea measure by the Medical Research Council scale, height, weight, Body Mass Index, Free Fat Mass Index determined by electrical bioimpedance, handgrip, abdominal and pelvic girth.
Laboratory: baseline and yearly The following information from the patient chart will be collected and registered: CBC (including differential specifically eosinophilia), CRP, baseline alfa 1 AT levels (only baseline), fibrinogen, basal ABG.
Physiological information: yearly evaluation The following information will be collected and registered: FEV1, FVC, FEV1/FVC, TLC, IC/TLC, RV/TLC, DLCO, KCO. MIP, MEP, 6MWD with and without O2 in those O2 Sat 90% or lower. In a sample of interest full Cardiopulmonary exercise test.
Radiological information: Yearly Low dose chest CT The following information will be registered from the final reports of the chest CT: Emphysema presence, type, extent and localization, PulmArt/Ao diameter ratio measurement, presence of bronchiectasis (type and localization), presence of air trapping, presence (type and localization) of interstitial changes, presence of coronary calcifications, presence of osteoporosis, presence of lung nodules---- Lung cancer.
Data storage and identification Data will be stored in an encrypted file behind a firewall in a KGH server. For research purpose patient's information will be anonimized by using a study ID number that will be linked to the CR number of every patient in a different encrypted file. There will be no personal identifiable information during the entire process of each of the proposed studies.
Statistical analysis plan The description of the characteristics of the participants will follow the following methodology: qualitative data will be described using relative frequencies. We will use the Kolmogorov-Smirnov test (K-S) to determine if a quantitative variable has a normal distribution. Quantitative data with a normal distribution will be expressed using the mean and the standard deviation (SD).
When comparison between groups is planned the following methodological plan will be applied: quantitative data with non-normal distribution will be described with the median and the interquartile range (IQR). Differences will be compared with chi square for qualitative data or student t test and Mann-Whitney U test for quantitative data according to each variable distribution.
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD | Long term (at least 10 years) multidimensional (clinical, laboratory, physiological and radiological) follow up of chronic Obstructive Pulmonary Disease patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Patients that will die during the follow up period
Measured: 10 years
Exacerbations
Number of COPD exacerbations per year
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start14 Jan 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 400 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Dr. Juan Pablo de Torres Tajes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Juan Pablo de Torres Tajes, Queen's University
- Investigators
- Juan P de Torres, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200079
- Sponsor's protocol ID
- 43105
- Acronym
- KCOCO
- Status last verified
- Sep 2021
- First submitted
- 12 Dec 2019
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only on specific request
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kingston COPD Cohort
- ClinicalTrials.gov ID
- NCT04200079
- Acronym / sponsor ID
- KCOCO / 43105
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Dr. Juan Pablo de Torres TajesUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 16 Dec 2019 (actual)
- 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.
Background: Chronic Obstructive Pulmonary (COPD) patients are the paradigm of the chronic complex patient. Their follow up can sometimes be difficult and challenging (1). There are patients with recurrent exacerbations that put an enormous burden on health care resources (2). They also have multiple comorbidities (3) that can sometimes make their management difficult. In an attempt to coordinate all these efforts KGH, HDH and Providence Care have numerous essential resources to take care of COPD patients like the nurse navigators, nurse practitioners and the pulmonary rehabilitation program. These programs provide an excellent support to the clinical activity of Respirologists and other health care providers.
Rationale: The main rationale for the development of the Kingston COPD cohort is to translate that highly demanding clinical activity in a teaching and research oriented activity that could be used by clinicians, medical students, residents and fellows. Having a guideline complained established protocol in COPD patients that are usually follow at KGH and HDH could help in not only in unified the way COPD patients are seeing (preserving the importance of the personalized approach) but most importantly established a multidimensional (clinical, physiological, radiological, laboratory) database. This could help know not only the results of our clinical activity but also have a long term (>5yrs) database for clinical research projects in collaboration with national and international research groups. Therefore this proposal is important because it will help translate our busy daily clinical work in a highly productive teaching and research activity.
Detailed description
Aims: establish a long term multidimensional follow up of a large COPD cohort of COPD patients in Kingston, Ontario.
Specific Objectives: 1. established a simple and easy to apply follow up protocol in COPD patients. 2. Hire a research assistant 3. Set up the database.
Data source: Patients included in the present cohort will be those usually follow at the Respirology clinic at Hotel Dieu Hospital in Kingston Ontario.
Data elements: this will include clinical, laboratory, physiological and radiological data.
Clinical: baseline and yearly evaluation. The following information will be collected and registered: Age, gender, history of prematurity and low weight at birth, maternal smoking during pregnancy, history of infections or wheezing during infancy, pack year history: (age of smoking initiation, years smoking, packs per day, age of quitting if quit), active or former smokers, use of vaping or marihuana?, registration of Comorbidities using the Copd cOmorbidiTy indEx COTE index, use of medications: LABA, LAMA, dual, LABA/ICS, ICS, Roflumilast, Erithromycin, NAC, etc, use of O2 at home: lt/min and duration, CPAP and BiPAP and pressures, degree of dyspnea measure by the Medical Research Council scale, height, weight, Body Mass Index, Free Fat Mass Index determined by electrical bioimpedance, handgrip, abdominal and pelvic girth.
Laboratory: baseline and yearly The following information from the patient chart will be collected and registered: CBC (including differential specifically eosinophilia), CRP, baseline alfa 1 AT levels (only baseline), fibrinogen, basal ABG.
Physiological information: yearly evaluation The following information will be collected and registered: FEV1, FVC, FEV1/FVC, TLC, IC/TLC, RV/TLC, DLCO, KCO. MIP, MEP, 6MWD with and without O2 in those O2 Sat 90% or lower. In a sample of interest full Cardiopulmonary exercise test.
Radiological information: Yearly Low dose chest CT The following information will be registered from the final reports of the chest CT: Emphysema presence, type, extent and localization, PulmArt/Ao diameter ratio measurement, presence of bronchiectasis (type and localization), presence of air trapping, presence (type and localization) of interstitial changes, presence of coronary calcifications, presence of osteoporosis, presence of lung nodules---- Lung cancer.
Data storage and identification Data will be stored in an encrypted file behind a firewall in a KGH server. For research purpose patient's information will be anonimized by using a study ID number that will be linked to the CR number of every patient in a different encrypted file. There will be no personal identifiable information during the entire process of each of the proposed studies.
Statistical analysis plan The description of the characteristics of the participants will follow the following methodology: qualitative data will be described using relative frequencies. We will use the Kolmogorov-Smirnov test (K-S) to determine if a quantitative variable has a normal distribution. Quantitative data with a normal distribution will be expressed using the mean and the standard deviation (SD).
When comparison between groups is planned the following methodological plan will be applied: quantitative data with non-normal distribution will be described with the median and the interquartile range (IQR). Differences will be compared with chi square for qualitative data or student t test and Mann-Whitney U test for quantitative data according to each variable distribution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD | – | –Long term (at least 10 years) multidimensional (clinical, laboratory, physiological and radiological) follow up of chronic Obstructive Pulmonary Disease patients. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients usually followed at a Respirology clinic
Key inclusion criteria (5 listed)
- Patients ages between 40-85 years old.
- Smoking history of at least 10 pack year history
- Active of former smokers
- Diagnosis of COPD according to the GOLD definition (4): post bronchodilator spirometry FEV1/FVC ≤0.70, including those with other associated respiratory diseases like asthma, bronchiectasis, stable lung cancer or Interstitial Lung Disease.
- Ability to perform all study procedures (complete pulmonary function tests, six minute walking test (6MWT) and chest computed tomography) and provide/sign informed consent.
Key exclusion criteria (5 listed)
- Patients not willing to sign the consent form
- Patients with a life expectancy of less than 3 yrs.
- Patients in palliative care.
- Patients with chronic airway obstruction ie: FEV1/FVC≤0.70 of other etiology and without a smoking history of less than 10 packs year history.
- Patients unable ort not able to perform the pulmonary function test, the 6MWT or the chest CT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 10 years
Patients that will die during the follow up period
Exacerbations
Time frame: 10 years
Number of COPD exacerbations per year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No. Only on specific request
Related trials for COPD
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
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.
Juan P de Torres, MD principal investigator
Queen's University
1 site 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 Emphysema, run by Dr. Juan Pablo de Torres Tajes at 1 site in Canada.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan P de Torres, MD (613 549 6666 ext. 6905, jpdt@queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2021.