Recruiting

Observational Study

Sponsor:

Dr. Juan Pablo de Torres Tajes

Code:

NCT04200079

Conditions

COPD

Emphysema

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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). 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.

Conditions

COPD

Emphysema

Study ID

NCT04200079

Start date

Jan 14, 2020

Status verified date

Sep, 2021

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients ages between 40-85 years old.
2. Smoking history of at least 10 pack year history
3. Active of former smokers
4. 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.
5. Ability to perform all study procedures (complete pulmonary function tests, six minute walking test (6MWT) and chest computed tomography) and provide/sign informed consent.

Exclusion Criteria:

1. Patients not willing to sign the consent form
2. Patients with a life expectancy of less than 3 yrs.
3. Patients in palliative care.
4. 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.
5. Patients unable ort not able to perform the pulmonary function test, the 6MWT or the chest CT.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

COPD

Long term (at least 10 years) multidimensional (clinical, laboratory, physiological and radiological) follow up of chronic Obstructive Pulmonary Disease patients.

Primary outcome measure

  • Mortality [ Time Frame: 10 years ]
  • Exacerbations [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Locations

KHSC

Recruiting

Kingston, Ontario, Canada, K7L2V6

Contacts

Juan P de Torres, MD

613 549 6666jpdt@queensu.ca

More Information

Sponsor

Dr. Juan Pablo de Torres Tajes

Last update posted

Sep 14, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Juan Pablo de Torres Tajes on 2021-09-14.