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

Smokers Clinical Trial

— smoker3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141633
• Other study ID #: 20120896
• Status: Completed
• Phase: N/A
• First received: March 25, 2014
• Last updated: January 8, 2016
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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).

Other known NCT identifiers

• NCT02026375

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women

• Cardiovascular disease and/or use of cardiovascular medications

• Subjects with known beta-adrenergic agonist intolerance

• A physician diagnosis of chronic airway disease (asthma, COPD, bronchiectasis, cystic fibrosis)

• Acute respiratory infection within four weeks prior to the study

• Use of any airway medication

• Abnormal pulmonary function

Study Design

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

Related Conditions & MeSH terms

• Smokers

Intervention

Drug:
• placebo
4 weeks treatment
• Fluticasone propionate
4 weeks treatment

Locations

Country	Name	City	State
United States	University of Miami School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	airway blood flow	compare inhaled albuterol-induced changes in airway blood flow in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway circulation and to compare the results between smokers and non-smokers	before and 5 minutes after albuterol inhalation	No
Secondary	airway blood flow	determine the effect of a 4-week treatment with an ICS on albuterol responsiveness of Qaw	4 weeks	No
Secondary	echocardiogram	determine the effect of a 4-week treatment with an ICS on albuterol responsiveness of the pulmonary circulation	4 weeks	No
Secondary	echocardiogram	to compare inhaled albuterol-induced changes in echocardiogram in healthy current smokers and lifetime non-smokers as an index of endothelial function in the pulmonary circulation and to compare the results between smokers and non-smokers	before and 5 minutes after albuterol inhalation	No