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

NCT02141633 | Completed Results

• 1 other identifier: 20120896
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking

Keywords

smokers; airway blood flow; fluticasone; echocardiogram

Outcome Measures

Primary Outcomes (1)

• Airway Blood Flow

  compare inhaled albuterol-induced changes in airway blood flow (ΔQaw) 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 15 minutes after albuterol inhalation

Secondary Outcomes (1)

• Echocardiogram

  MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers

Study Arms (2)

smokers

EXPERIMENTAL

participants with smoking history ( \> 10 pack/year) will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation

Procedure: echocardiogram plus albuterol; Procedure: airway blood flow plus albuterol; Drug: Fluticasone propionate; Drug: placebo

non-smokers

EXPERIMENTAL

healthy life-time non smokers will be enrolled and perform airway blood flow and echocardiogram before and 15 minutes after albuterol inhalation

Procedure: echocardiogram plus albuterol; Procedure: airway blood flow plus albuterol

Interventions

echocardiogram plus albuterol PROCEDURE

participants will performed echocardiogram before and 15 minutes after inhaled albuterol

non-smokers; smokers

airway blood flow plus albuterol PROCEDURE

participants will performed echocardiogram before and 15 minutes after inhaled albuterol

Also known as: Qaw

non-smokers; smokers

Fluticasone propionate DRUG

participant will be received a 4-week course of inhaled fluticasone (220 μg fluticasone twice a day administered as a MDI using a spacer)

smokers

placebo DRUG

participant will be received a 4-week course of identically appearing placebo (2 puffs twice a day via spacer).

smokers

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Albuterol; Fluticasone

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr Adam Wanner Professor of Medicine Division of Pulmonary and Critical Care Medicine
• Organization: University of Miami

awanner@med.miami.edu

(305) 243-3045

Study Officials

• Adam Wanner, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: May 19, 2014
• Study Start: April 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 16, 2016
• Results First Posted: December 16, 2016

Record last verified: 2016-10

Locations

US (1)