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

NCT ID: NCT02141633

Last Updated: 2016-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Smoking

Keywords

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smokers airway blood flow fluticasone echocardiogram

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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smokers

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

Group Type EXPERIMENTAL

echocardiogram plus albuterol

Intervention Type PROCEDURE

participants will performed echocardiogram before and 15 minutes after inhaled albuterol

airway blood flow plus albuterol

Intervention Type PROCEDURE

participants will performed echocardiogram before and 15 minutes after inhaled albuterol

Fluticasone propionate

Intervention Type 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)

placebo

Intervention Type DRUG

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

non-smokers

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

Group Type EXPERIMENTAL

echocardiogram plus albuterol

Intervention Type PROCEDURE

participants will performed echocardiogram before and 15 minutes after inhaled albuterol

airway blood flow plus albuterol

Intervention Type PROCEDURE

participants will performed echocardiogram before and 15 minutes after inhaled albuterol

Interventions

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echocardiogram plus albuterol

participants will performed echocardiogram before and 15 minutes after inhaled albuterol

Intervention Type PROCEDURE

airway blood flow plus albuterol

participants will performed echocardiogram before and 15 minutes after inhaled albuterol

Intervention Type PROCEDURE

Fluticasone propionate

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

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Qaw

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Adam Wanner

Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Wanner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami School of Medicine

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20120896

Identifier Type: -

Identifier Source: org_study_id

NCT02026375

Identifier Type: -

Identifier Source: nct_alias