Trial Outcomes & Findings for Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment (NCT NCT02141633)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

before and 15 minutes after albuterol inhalation

Results posted on

2016-12-16

Participant Flow

Participant milestones

Participant milestones
Measure	Smokers participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol. echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol	Non-smokers participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol
Overall Study STARTED	16	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Smokers participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol. echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol	Non-smokers participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol
Overall Study Physician Decision	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Smokers n=16 Participants echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol	Non-smokers n=15 Participants echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	47.6 years STANDARD_DEVIATION 2.0 • n=5 Participants	44.7 years STANDARD_DEVIATION 2.0 • n=7 Participants	46.2 years STANDARD_DEVIATION 2.0 • n=5 Participants
Gender Female	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Gender Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	15 participants n=7 Participants	31 participants n=5 Participants

PRIMARY outcome

Timeframe: before and 15 minutes after albuterol inhalation

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

Outcome measures

Outcome measures
Measure	Smokers n=15 Participants participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol. echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol	Non-smokers n=15 Participants participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol
Airway Blood Flow	2.13 ΔQaw (ul/min/ml) Standard Error 2.52	13.05 ΔQaw (ul/min/ml) Standard Error 1.22

SECONDARY outcome

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

to compare inhaled albuterol-induced changes in echocardiogram measuring mean pulmonary artery pressure (MPAP)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

Outcome measures

Outcome measures
Measure	Smokers n=15 Participants participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol. echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol	Non-smokers n=15 Participants participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol
Echocardiogram	-7.70 ΔMPAP (mmHg) Standard Error 1.37	-9.04 ΔMPAP (mmHg) Standard Error 0.74

Adverse Events

Smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-smokers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Adam Wanner Professor of Medicine Division of Pulmonary and Critical Care Medicine

University of Miami

Phone: (305) 243-3045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place