Evaluation of COPD (Chronic Obstructive Pulmonary Disease) to Longitudinally Identify Predictive Surrogate Endpoints

Study Overview
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Brief Summary
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This is a 3 year longitudinal study to identify novel endpoints and compare these with standard measures such as forced expiratory volume in 1 second (FEV1) for their ability to measure and predict COPD (Chronic Obstructive Pulmonary Disease) severity and its progression over time. Control subjects (smokers and never smokers) will be recruited as comparators with the COPD subjects.

Official Title
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A Multicentre 3 Year Longitudinal Prospective Study to Identify Novel Endpoints and Compare These With Forced Expiratory Volume in 1 Second (FEV1) for Their Ability to Measure and Predict COPD Severity and Its Progression Over Time

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Other: Novel endpoint determination


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: COPD Subjects A COPD subject will be eligible for inclusion in this study only if all of the following criteria apply: Male or female subjects, aged 40-75 years inclusive A baseline (post-bronchodilator) FEV1 <80% of predicted normal and a baseline (post-bronchodilator) FEV1/FVC ratio 70% Current or ex-smokers with a smoking history of at least 10 pack-years (number of pack years = (number of cigarettes per day / 20) x number of years smoked e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years). A signed and dated written informed consent is obtained prior to participation Able to comply with the requirements of the protocol and be available for study visits over 3 years Control Subjects - Current/Ex Smokers A control subject will be eligible for inclusion in this study only if all of the following criteria apply: Male or female subjects, aged 40-75 years inclusive, who are free from significant disease as determined by history, physical examination and screening investigations Baseline (post-bronchodilator) FEV1 >85% of predicted normal. FEV1/FVC ratio >70% Current or ex-smokers with a smoking history of at least 10 pack-years (number of pack years = (number of cigarettes per day / 20) x number of years smoked e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years). A signed and dated written informed consent is obtained prior to participation. Able to comply with the requirements of the protocol and be available for study visits over 3 years Control Subjects - Non-smokers A non-smoking control subject will be eligible for inclusion in this study only if all of the following criteria apply: Male or female subjects, aged 40-75 years inclusive, who are free from significant disease as determined by history, physical examination and screening investigations Baseline (post-bronchodilator) FEV1 >85% of predicted normal. FEV1/FVC ratio >70% Non-smokers with a smoking history of < 1 pack-year (number of pack years = (number of cigarettes per day / 20) x number of years smoked). A signed and dated written informed consent is obtained prior to participation. Able to comply with the requirements of the protocol and be available for study visits over 3 years Exclusion Criteria: COPD Subjects A COPD subject will not be eligible for inclusion in this study if any of the following criteria apply: Known respiratory disorders, or disorders identified at screening/visit 1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis) Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and Lupus) Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ) Having undergone lung surgery (e.g. lung reduction, lung transplant) Have cancer or have had cancer in the 5 years prior to study entry Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety Is enrolled in a long term blinded drug study (subjects in open label studies may be considered and subjects in short blinded studies (approx less than 12 weeks may be considered following consultation with sponsor) or a study where there is significant radiation exposure (e.g.: CT scans) Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse Have received a blood transfusion in the 4 weeks prior to study start Has experienced a moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) within the last 4 weeks. All courses of oral corticosteroids and antibiotics must be completed at least 2 weeks before study start Is on long term oral corticosteroids (long term is considered use for more than 3 consecutive months) Unable to walk Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned. Control Subjects A control subject will not be eligible for inclusion in this study if any of the following criteria apply: Known respiratory disorders, or disorders identified at screening/visit 1 including identification on the first CT scan (e.g.: COPD, asthma, lung cancer, sarcoidosis, tuberculosis, lung fibrosis) Known history of significant inflammatory disease (eg rheumatoid arthritis and Lupus) Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ) Having undergone lung surgery (e.g. lung reduction, lung transplant) Have cancer or have had cancer in the 5 years prior to study entry Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study Is enrolled in a long term blinded drug study (subjects in open label studies may be considered and subjects in short blinded studies (approx less than 12 weeks may be considered following consultation with sponsor) or a study where there is significant radiation exposure (e.g.: CT scans) Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse. Have received a blood transfusion in the 4 weeks prior to study start Is on long term oral corticosteroids (long term is considered use for more than 3 consecutive months) Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD subjects<br>Subjects with GOLD stage II-IV COPD | Other: Novel endpoint determination<br>* Novel endpoint determination<br>|
| Smoker controls<br>Subjects with smoking history but normal lung function | Other: Novel endpoint determination<br>* Novel endpoint determination<br>|
| Non-smoker controls<br>Normal healthy non-smokers | Other: Novel endpoint determination<br>* Novel endpoint determination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identifying new patient subtypes and endpoints for COPD |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease (COPD), longitudinal, eclipse