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New study tracks early lung disease in young smokers

NCT ID NCT04968249

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study follows 200 adults aged 30-55 who smoke or have early COPD to learn how the disease progresses. Researchers will use breathing tests, symptom surveys, and CT scans to find early warning signs. The goal is to better understand risk factors and improve future care for COPD.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help identify early signs of COPD and risk factors, leading to better prevention or earlier treatment strategies.
What could go wrong
This is an observational study, not testing a treatment. It may not directly lead to new therapies, and results may not apply to all COPD patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

200 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients meeting inclusion criteria who have established disease as well as smokers meeting inclusion criteria where pulmonary function testing has not been performed.

Ages

30 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * GOLD 0 Participant must be ages 30-55 years; and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC ≥ 0.70 and FEV1 ≥ 80% predicted. * Preserved Ratio Impaired Spirometry (PRISm) participants shall be between ages 30-55 years; and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV150-79% predicted and FEV1/FVC \> 0.70. * GOLD 1 participants shall be between ages 30-55 years, and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC \< 0.70 and FEV1 \>= 80% predicted. OR * GOLD 2 participants shall be between ages 30-55 years, and have: ≥ 10 pack-year smoking history; post-bronchodilator FEV1/FVC \< 0.70 and FEV1 50-79% predicted. Exclusion Criteria: * Severe asthma, which is defined as any of the following: Current (i.e., at the time of the visit) GINA Step 4 or higher therapy (medium dose ICS/LABA or high dose ICS or add-on 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 3 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 or return visits. 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/m2 at baseline, due to the effects of body weight on CT scan imaging quality. * The presence of a respiratory condition other than COPD or asthma, 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 3 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.