Status:
UNKNOWN
Innate Immunity in Ozone-induced Airway Inflammation in COPD
Lead Sponsor:
University of California, San Francisco
Conditions:
Pulmonary Disease, Chronic Obstructive
Airway Disease
Eligibility:
All Genders
45-75 years
Phase:
NA
Brief Summary
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 ca...
Detailed Description
A major cause of morbidity and mortality in COPD is exacerbation. The mechanisms underlying COPD exacerbation are poorly understood, but airway innate immune system has been implicated in its developm...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
- 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.
- 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.
- Liver cirrhosis.
- History of chronic active Hepatitis B or C
- 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.
Key Trial Info
Start Date :
April 7 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04669743
Start Date
April 7 2016
End Date
October 1 2024
Last Update
June 8 2022
Active Locations (3)
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1
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States, 94110
2
San Francisco VA Medical Center
San Francisco, California, United States, 94121
3
University of California, San Francisco
San Francisco, California, United States, 94122