Smokers Clinical Trial - Airway & Pulmonary Vascular Endothelial Function

Status Completed

Clinical Trial Summary

The purposes of the present proposal are to 1) compare inhaled albuterol-induced changes in airway blood flow (Qaw), and in CO and Ppas in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway and pulmonary circulations, 2) compare the results between smokers and non-smokers, and 3) determine the effect of a 4-week treatment with an ICS on albuterol responsiveness of Qaw and the echocardiographic parameters. With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.

Clinical Trial Description

With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.

Fifteen healthy current smokers with a >10 pack-year history of smoking and 15 healthy never-smokers will be enrolled. Males and females between 25 and 75 years of age will be recruited There will be 1-4 visits to the laboratory (one for non-smokers, 4 for smokers). All subjects will have the first visit. Current smokers will have 3 additional visits. Current smokers will be asked not to smoke before coming to the laboratory on the 3 study days. All subjects will be instructed to abstain from ingesting alcoholic beverages, coffee or caffeinated drinks for at least 12 hours the night before each study day. The subjects will also be instructed not to use PDE5 inhibitors for 24 hours before coming to the laboratory. On each study day, the protocol will start at the same time (in the morning). ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

Smokers

Clinical Trial Details

NCT number	NCT02141633
Study type	Interventional
Source	University of Miami
Contact
Status	Completed
Phase	N/A
Start date	April 2013
Completion date	December 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06123598` - Effects of Mental Practice and Therapeutic Exercise in Mild Smokers	N/A
Active, not recruiting	`NCT06108323` - Immediate Effects of Mental Practice and Therapeutic Exercise in Mild Smokers	N/A
Completed	`NCT01213706` - Effect of Whole Body Periodic Acceleration on Airway Endothelial Function	N/A
Completed	`NCT00781599` - Improving Medication Compliance and Smoking Cessation Treatment Outcomes for African American Smokers	N/A
Completed	`NCT02354677` - Repair, Remodeling and Regeneration of the Bronchial Epithelium of COPD Patients	N/A
Completed	`NCT00918073` - Evaluation of Cardiovascular Effects of Smoking Cessation in HIV Patients	N/A
Completed	`NCT03299595` - Oral Mucosal Lesions Among Smokers in an Egyptian Population.
Not yet recruiting	`NCT03299634` - Oral Mucosal Lesions Among Smokers in an Egyptian Population Study.	N/A
Completed	`NCT01182129` - 4 mg Nicotine Polacrilex Gum and Swedish Portion Snus	Phase 1/Phase 2
Completed	`NCT00483015` - Differences in the Presentation Outcome and Response to Treatment Between Never- Smokers and Smokers With NSCLC	N/A
Terminated	`NCT01345383` - Impact of Current Smoking in the Tolerance of Bronchoscopy	N/A
Completed	`NCT01362101` - Effect of Behavioral Training on Physiological Responses to Smoking Cues, Affect and Cortisol	Phase 4
Completed	`NCT01734330` - Cognitive Behaviour Therapy and Nicotine Replacement to Increase Tobacco Cessation	N/A
Completed	`NCT00341640` - Metabolism of Nicotine and Cotinine in Pregnant African-American Women	Phase 1
Completed	`NCT03086707` - Prefatory Study to Explore Changes in Nasal Mucociliary Clearance and to Standardize Nasal Scraping Procedure	N/A
Completed	`NCT01566968` - Novel Endpoints in Cough Challenge Testing	N/A
Active, not recruiting	`NCT05758272` - Evaluation of a Workplace Smoking Cessation Program in Hong Kong (Phase VI)	N/A
Completed	`NCT03608293` - Smoker Extracellular Vesicles Influence on Human Bronchial Epithelial Cells	N/A
Not yet recruiting	`NCT04252781` - Incident Chronic Obstructive pulmoNary dIsease Cohort Study (ICONIC)	N/A
Completed	`NCT00369616` - Efficacy and Safety of Nicotine-Qbeta Vaccine in Smokers	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment — smoker3

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms