No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
University of California, San Francisco · Other
Who this trial is looking for
This trial is looking for adults over 40 who have been exposed to secondhand tobacco smoke for at least 5 years and have not smoked much themselves. Participants will take a medication called losartan to see if it improves heart and lung health.
Are You a Good Fit for This Trial?
You may be able to join if
I understand and can provide consent.
I am 40 years or older.
I have been exposed to secondhand tobacco smoke for at least 5 years.
I have never smoked or only smoked very lightly in my life.
You may not be able to join if
I am pregnant, breastfeeding, or plan to become pregnant.
I am currently taking an ACE inhibitor or ARB.
I have a history of angioedema.
I have severe high blood pressure or low blood pressure.
I have kidney problems.
I have a history of significant heart disease.
I have a history of significant lung disease.
I have a physical disability that prevents exercise testing.
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 three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is a double-blind randomized placebo-controlled crossover clinical trial of efficacy and safety of an FDA-approved angiotensin receptor blocker (losartan) to improve cardiopulmonary outcomes in individuals with pre-Chronic Obstructive Pulmonary Disease (COPD) due to prolonged exposure to secondhand tobacco smoke.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Must be able to understand and provide informed consent.
* Adults \>= 40 years of age.
* Must have a history of occupational exposure to secondhand tobacco smoke for at least 5 years such as flight attendants who worked for airlines before the smoking ban on aircrafts went int…
Inclusion Criteria:
* Must be able to understand and provide informed consent.
* Adults \>= 40 years of age.
* Must have a history of occupational exposure to secondhand tobacco smoke for at least 5 years such as flight attendants who worked for airlines before the smoking ban on aircrafts went into effect or casino workers who worked at casinos with no smoke-free policies.
* Must have never smoked or have a remote history of light smoking defined as follows:
* Lifetime smoking history equivalent to \< 1 pack-year and
* No smoking history for \>= 20 years at the time of enrollment.
Exclusion Criteria:
* Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
* Subject is pregnant, breast-feeding, or plans to become pregnant.
* Current therapy with angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
* Known intolerance to ACE inhibitor or ARB.
* History of angioedema.
* Conventional indication for ACE inhibitor or ARB (e.g., history of myocardial infarction, known cardiomyopathy).
* Blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic while standing or sitting.
* Known unilateral or bilateral renal artery stenosis higher than 70%.
* Renal insufficiency (Creatinine Clearance \<30 mL/min by Cockcroft-Gault calculation).
* Current regular use of NSAIDs defined as daily use on 5 or more days of the week for more than one month.
* Potassium supplementation or serum potassium level of 5.0 milliequivalents (mEq)/dL or higher at V1.
* Current use of a potassium sparing diuretic.
* History of clinically overt cardiovascular disease including: stable or unstable angina; chest discomfort and dyspnea with baseline exertion; symptomatic coronary artery disease (as defined by history of abnormal stress test; cardiac catheterization showing \>70% coronary artery stenosis; history of revascularization; pathologic Q waves on EKG); poorly controlled resting hypertension (SBP\>160/ DBP\>95); congestive heart failure (CHF) (as defined by left ventricular ejection fraction (LVEF) \<55%; physical exam findings of CHF; symptomatic pulmonary edema); significant (\>mild) valvular heart disease; congenital heart disease; cardiac arrhythmias including frequent premature atrial or ventricular contractions (\>5 per minute).
* History of clinically overt pulmonary disease that may interfere with study procedures, including: greater than mild asthma, COPD, emphysema, chronic interstitial lung disease, and pulmonary hypertension.
* Neuromuscular disorders or physical disability to perform exercise testing using an ergometer.
* Significant history of recreational drug use other than marijuana as defined by: recreational drug use within the last 30 years of recruitment (or) recreational drug use at a frequency of more than once a month before 30 years.
* Marijuana use more than once a week.
* Other uncontrolled chronic illnesses which in the judgment of the study physician would interfere with completing study procedures.
* Failure to keep screening appointments or other indicators of non-adherence.
* Concomitant participation in another interventional study.
* Subjects with BMI \<15 or \>40 kg/m2.
* MRI Scan Participation Exclusion Criteria - The participants will be excluded from the MRI portion of the study if they have a metallic object embedded or implanted in their body that is incompatible with Magnetic Resonance (MR) scanning, including MR incompatible pacemaker or defibrillator.
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