Clinical & Systems Medicine Investigations of Smoking-related Chronic Obstructive Pulmonary Disease (NCT02627872) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical & Systems Medicine Investigations of Smoking-related Chronic Obstructive Pulmonary Disease
Sweden120 participantsStarted 2007-03
Plain-language summary
Chronic Obstructive Pulmonary Disease (COPD) is an increasing global health problem, which primarily increases among the female population. The purpose of this study is to perform in-depth clinical and molecular characterizations of early stage COPD patients, as well as healthy never-smoker and at-risk smoking control populations to identify molecularly related subgroups patients, including gender-related sub-phenotypes of COPD.
Who can participate
Age range
45 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* For smokers, at least 10 pack-years of cigarette smoking
* For smokers, at least 10 cigarettes/day the past 6 months before study entry Spirometry that meets stage I-II of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages (postbronchodilator forced expiratory volume in 1 second (FEV1) of 50%-100% of predicted level and FEV1/forced vital capacity \[FEV1/FVC\] less than 0.7) or normal (postbronchodilator FEV1 greater than 80% of predicted level and forced expiratory volume in 1 second/forced vital capacity \[FEV1/FVC\] greater than 0.7)
Exclusion Criteria:
* Other lung diseases
* Atopy (defined as positive specific IgE test)
* Asthma
* Received antibiotics for a COPD exacerbation in the 3 months prior to study entry
* Treatment with oral or inhaled glucocorticoids within past 3 months prior to study entry
* Significant ischaemic heart disease or arrhythmia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Forced expiratory volume in 1 second (FEV1)
Timeframe: Measured at baseline and up to 10 year follow-up
2
Emphysema, as shown on chest CT scan
Timeframe: Measured at baseline and up to 10 year follow-up
3
Airway wall thickness on chest CT scan
Timeframe: Measured at baseline and up to 10 year follow-up
4
COPD status (COPD participants versus control group participants)
Timeframe: Measured at baseline and up to 10 year follow-up