Trial Outcomes & Findings for Effect of an Inhaled Glucocorticosteroid (ICS) on Endothelial Dysfunction in Cigarette Smokers (NCT NCT01216735)

NCT ID: NCT01216735

Last Updated: 2016-06-29

Results Overview

Airway Blood flow (Qaw) will be measured before and 15 minutes after albuterol inhalation (delta Qaw).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: 3 weeks treatment period of ICS or placebo
• Results posted on: 2016-06-29

Participant Flow

17 Non-smokers were enrolled to provide baseline measures and did not receive any intervention or treatment

Participant milestones

Measure	Fluticasone First, Then Placebo The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) or placebo. The subjects and the investigators will be blinded to the random choice of inhaler. Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI) or matching placebo	Placebo First, Then Fluticasone The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) or placebo. The subjects and the investigators will be blinded to the random choice of inhaler. Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI) or matching placebo
First Intervention (3 Weeks) STARTED	8	7
First Intervention (3 Weeks) COMPLETED	8	7
First Intervention (3 Weeks) NOT COMPLETED	0	0
Washout (3 Weeks) STARTED	8	7
Washout (3 Weeks) COMPLETED	8	7
Washout (3 Weeks) NOT COMPLETED	0	0
Second Intervention (3 Weeks) STARTED	8	7
Second Intervention (3 Weeks) COMPLETED	8	7
Second Intervention (3 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of an Inhaled Glucocorticosteroid (ICS) on Endothelial Dysfunction in Cigarette Smokers

Baseline characteristics by cohort

Measure	Smokers n=15 Participants The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler. Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)	Non-smokers n=17 Participants this group served as controls for baseline data. No intervention or treatment were assigned to this group.	Total n=32 Participants Total of all reporting groups
Age, Continuous age	44 years n=5 Participants	38 years n=7 Participants	42 years n=5 Participants
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	15 Participants n=5 Participants	17 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	17 participants n=7 Participants	32 participants n=5 Participants
Airway blood flow (Qaw)	50.3 um/ml/ul STANDARD_DEVIATION 3.7 • n=5 Participants	46.2 um/ml/ul STANDARD_DEVIATION 3.5 • n=7 Participants	48.2 um/ml/ul STANDARD_DEVIATION 3.4 • n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks treatment period of ICS or placebo

Airway Blood flow (Qaw) will be measured before and 15 minutes after albuterol inhalation (delta Qaw).

Outcome measures

Measure	Fluticasone n=15 Participants The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler. Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)	Placebo n=15 Participants The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler. Placebo: Placebo MDI
Albuterol Induced Change in Qaw Before and After Fluticasone or Placebo	40.9 % change Standard Error 7.3	0.0 % change Standard Error 3.2

SECONDARY outcome

Timeframe: 3 weeks of treatment

Flow-mediated vasodilation response in the brachial artery will be measured before and 15 minutes.after albuterol inhalation

Outcome measures

Measure	Fluticasone n=15 Participants The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler. Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)	Placebo n=15 Participants The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler. Placebo: Placebo MDI
Flow-mediated Brachial Vasodilation (FMD% Peak Delta)	3.9 % change Standard Error 0.6	4.8 % change Standard Error 0.6

Adverse Events

Fluticasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Adam Wanner, MD

University of Miami

Phone: (305) 243-2568

Email: awanner@med.miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place