SPIROMICS Study of Early COPD Progression (SOURCE)
Recruiting
Observational Study
COPD, Early-Onset
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
30 – 55
Sex
Any
Study type
Observational
Participants needed
1,000 (estimated)
Sponsor
University of Massachusetts, Worcester · Other
Who this trial is looking for
This trial is looking for people aged 30-55 to study early chronic obstructive pulmonary disease (COPD). Participants will undergo tests like breathing tests and provide samples to help researchers understand who is at risk of developing COPD.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 30 and 55 years old.
I am a smoker with a history of smoking or a healthy non-smoker.
I have no more than 100 lifetime cigarettes if I am a non-smoker.
I have a smoking history of at least 10 pack-years if I smoke.
My breathing function tests meet the study's requirements.
You may not be able to join if
I have severe asthma.
I am currently pregnant or planning to become pregnant.
I have cognitive issues that prevent me from participating.
My BMI is over 35.
I have another serious respiratory condition.
I have had recent healthcare visits or hospitalizations for asthma.
I have a history of illegal drug use within the last 10 years.
I have known HIV/AIDS.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is an observational study of 1000 participants to further define the nature of early chronic obstructive pulmonary disease (COPD) in younger, at-risk individuals.
The study has three main goals:
* To use CT scan imaging to identify which smokers will develop COPD.
* To identify biomarkers predictive of smokers that will develop COPD.
* To determine if sputum (phlegm) can be analyzed to pred…
This is an observational study of 1000 participants to further define the nature of early chronic obstructive pulmonary disease (COPD) in younger, at-risk individuals.
The study has three main goals:
* To use CT scan imaging to identify which smokers will develop COPD.
* To identify biomarkers predictive of smokers that will develop COPD.
* To determine if sputum (phlegm) can be analyzed to predict which smokers will develop COPD.
Procedures (methods): All participants will undergo study related questionnaires assessing medical history, smoke exposure and use, medication use, social and behavioral health, pulmonary symptoms, food frequency, and will provide nasal swab, blood, stool, and urine samples, pulmonary function testing to determine function, sputum induction to provide a sputum sample for airway biospecimen analysis, and CT imaging of the lungs.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 40 of the 1000 will be healthy controls: ages 30-55 years; with no smoking history (\< 100 cigarettes in lifetime), including vaping and cannabis use; pre-bronchodilator FEV1/FVC \> 0.70; pre-bronchodilator FEV1 \> 80% predicted; pre-bronchodilator FVC \> 80% predicted; Chroni…
Inclusion Criteria:
* 40 of the 1000 will be healthy controls: ages 30-55 years; with no smoking history (\< 100 cigarettes in lifetime), including vaping and cannabis use; pre-bronchodilator FEV1/FVC \> 0.70; pre-bronchodilator FEV1 \> 80% predicted; pre-bronchodilator FVC \> 80% predicted; Chronic Airway Assessment Test (CAAT) score \< 10. Willingness to also participate in the bronchoscopy sub-study is only required of the 20 healthy controls recruited from the clinical centers participating in the sub-study.
* Approximately one-third of the 960 will be GOLD 0 participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC \> 0.70 and FEV1 \> 80% predicted.
* Approximately one-third of the 960 will be Preserved Ratio Impaired Spirometry (PRISm) participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC \> 0.70 and FEV1 \< 80% predicted.
* Approximately one-third of the 960 will be GOLD 1-2 participants: ages 30-55 years; with ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC \< 0.70 and FEV1 \> 50% predicted.
Exclusion Criteria:
* Severe asthma, which is defined as any of the following:
* Current (i.e., at the time of the visit) Global Initiative for Asthma (GINA) Step 4 or higher therapy (medium dose inhaled corticosteroids (ICS)/long-acting beta agonist (LABA) or high dose ICS or add-on long-acting muscarinic agonist (LAMA); Medium dose \> 250 fluticasone propionate, = 100 fluticasone furoate, \> 200 beclomethasone, \> 400 budesonide, \> 220 mometasone). We will accept low-dose ICS/LABA or medium dose ICS; or
* Three or more unscheduled healthcare visits (provider/urgent care/ER) for asthma in the past 12 months; or
* One asthma hospitalization in the past 12 months.
* Concurrent participation in a therapeutic trial where treatment is blinded.
* Active pregnancy at the time of the baseline visit or planning to become pregnant during the course of the study. This special population is being excluded to minimize potential for fetal radiation exposure.
* Cognitive dysfunction that prevents the participant from completing study procedures.
* BMI \> 35.0 kg/m\^2 at baseline, due to the effects of body weight on CT scan imaging quality.
* The presence of a respiratory condition other than COPD (including chronic bronchitis and emphysema) or asthma, such as interstitial lung disease or pulmonary fibrosis, or of a comorbid condition that in the judgment of the investigator may be the principal cause of respiratory symptoms (e.g., dyspnea or decreased exercise tolerance).
* Any illness expected to cause mortality in the next three years.
* Any implanted metallic devices or prosthesis above the waist that could degrade thoracic CT scan image quality.
* History of thoracic radiation or thoracic surgery with resection of lung tissue.
* Known HIV/AIDS infection.
* Current illicit substance abuse, excluding marijuana.
* History of or current use of IV Ritalin.
* History of or current use of heroin.
* History of illegal IV drug use within the last 10 years or more than 5 instances of illegal IV drug use ever.
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