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NCT04669743Active, not recruiting

Innate Immunity in Ozone-induced Airway Inflammation in COPD

Source: ClinicalTrials.gov · Last updated 4 Jun 2026

Brief summary (registry, in English)

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death in the United States. Patients with COPD are routinely exposed to indoor and outdoor air pollution, which appears to cause escalation of their respiratory symptoms, a process called exacerbation, with resulting need to seek medical attention. This research plan proposes to evaluate the impact of lung immune cells in susceptibility to develop exacerbation through an experimental model of inhalational exposure using ambient levels of a component of air pollution (ozone) in COPD patients and longitudinal sampling of their lung immune cells.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
72 (estimated)
First submitted
14 Dec 2018
Start date
7 Apr 2016
Primary completion date
31 Dec 2030
Lead sponsor
University of California, San Francisco
Diseases
COPD
NCT number
NCT04669743

What you commit to

  • Study type: Interventional
  • Planned participants: 72
  • From 7 Apr 2016 to the primary completion date, 31 Dec 2030
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of IV drug use or inhalation of recreational drugs other than marijuana:
    • A- within the past 20 years. B- more than 100 usage. C- longer than 1 year.
  • Serious and active heart conditions - defined by stable or unstable angina, recent myocardial infarction (within the last 2 years), active congestive heart failure, ischemic cardiomyopathy.
  • History of chronic active Hepatitis B or C

Lab values

  • Malnourishment - determined by BMI less than 19. If subject has BMI greater or equal to 19, but has a history of malnourishment, study staff will measure albumin level of subject's blood after initial blood draw. Albumin level must be greater than 2.5 mg per deciliter, or subject will be excluded.

Other

  • COPD severity of GOLD stage IV.
  • Inability to walk briskly or run on treadmill or pedal on ergometer to perform the study-required moderate exercise level (achieve minute ventilation of 15 to 20 L/min/m2 body surface area).
  • Pregnant/breast feeding.
  • Liver cirrhosis.
  • On visits where moderate sedation is preformed, subject are required to have an escort home. Inability to secure a ride home will result in the subject being ineligible for the study.

Who the study is looking for

  • Group 1:
  • No diagnosis of COPD or asthma.
  • No spirometric evidence of airflow obstruction as determined by FEV1/FVC ratio = or \>0.7.
  • Less than 1 pack year history of tobacco smoking and no tobacco use within the past 12 months.
    • Group 2:
  • No diagnosis of COPD or asthma.
  • No spirometric evidence of airflow obstruction as determined by FEV1/FVC ratio = or \>0.7.
  • Current smoker with history of at least 20 pack-years smoking.
    • Group 3:
  • Diagnosis of COPD as determined by GOLD criteria (FEV1/FVC ratio \<0.7).
  • COPD severity of GOLD stage II or III (FEV1 \>40% predicted).
  • Smoking Status: Former smokers with history of at least 20 pack-years smoking.
    • Group 4:
  • Diagnosis of COPD as determined by GOLD criteria (FEV1/FVC ratio \<0.7).
  • COPD severity of GOLD stage II or III (FEV1 \>40% predicted).
  • Smoking Status: Current smokers with history of at least 20 pack-years smoking.
    • During subject screening visit, Albuterol is used to determine whether the subjects have COPD based on the Global Initiative on Obstructive Lung Diseases (GOLD) criteria. Regardless of whether the subject has reversibility to Albuterol or not, if they have an abnormal ratio after inhalation of Albuterol, they would meet the GOLD criteria for COPD and will be included in the study.

Age in the registry: 45 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of California San Francisco
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
Zuckerberg San Francisco General Hospital and Trauma Center
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
San Francisco VA Medical Center
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.