Trial Outcomes & Findings for Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide (NCT NCT01219738)

NCT ID: NCT01219738

Last Updated: 2015-01-16

Results Overview

Qaw will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: participants will be followed for 6 hours after budesonide dose
• Results posted on: 2015-01-16

Participant Flow

Participant milestones

Measure	All Study Participants asthmatic subject received different doses of inhaled budesonide Budesonide: A single inhaled dose of 360ug budesonide from a DPI. Budesonide: A single inhaled dose of 720ug budesonide from a DPI. Budesonide: A single dose of 1440ug of the budesonide from DPI. Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes. Placebo: A single inhaled dose of placebo from a DPI.
Overall Study STARTED	20
Overall Study Budesonide 360	20
Overall Study Budesonide 720	20
Overall Study Budesonide 1440	20
Overall Study Budesonide 720- 4 Times	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute Airway Vascular Smooth Muscle Effects of Inhaled Budesonide

Baseline characteristics by cohort

Measure	Asthma n=20 Participants asthmatic subject received different doses of inhaled budesonide Budesonide: A single inhaled dose of 360ug budesonide from a DPI. Budesonide: A single inhaled dose of 720ug budesonide from a DPI. Budesonide: A single dose of 1440ug of the budesonide from DPI. Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes. Placebo: A single inhaled dose of placebo from a DPI.
Age, Continuous	43 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Airway blood flow	52.3 μl/min/ml STANDARD_DEVIATION 3.5 • n=5 Participants

PRIMARY outcome

Timeframe: participants will be followed for 6 hours after budesonide dose

Qaw will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.

Outcome measures

Measure	Budesonide 360ug n=20 Participants Budesonide: A single inhaled dose of 360ug budesonide from a DPI.	Budesonide 720ug n=20 Participants Budesonide: A single inhaled dose of 720ug budesonide from a DPI.	Budesonide 1440ug n=20 Participants Budesonide: A single dose of 1440ug of the budesonide from DPI.	Budesonide 720ug 4 Times n=18 Participants Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.	Placebo n=20 Participants Placebo: A single inhaled dose of placebo from a DPI
Airway Blood Flow (Qaw)	22.3 percentage of change from baseline Standard Error 2.1	29.4 percentage of change from baseline Standard Error 2.7	34.1 percentage of change from baseline Standard Error 2.5	28.2 percentage of change from baseline Standard Error 1.9	5.1 percentage of change from baseline Standard Error 2.4

SECONDARY outcome

Timeframe: participant will be followed up to 6 hours after budesonide dose

FEV1 will be measured before and up to 6 hours after a single inhaled dose of 360ug, 720ug, and 1440ug budesonide or placebo from a DPI, using a double-blinded randomized design on different days.

Outcome measures

Measure	Budesonide 360ug n=20 Participants Budesonide: A single inhaled dose of 360ug budesonide from a DPI.	Budesonide 720ug n=20 Participants Budesonide: A single inhaled dose of 720ug budesonide from a DPI.	Budesonide 1440ug n=20 Participants Budesonide: A single dose of 1440ug of the budesonide from DPI.	Budesonide 720ug 4 Times n=18 Participants Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.	Placebo n=20 Participants Placebo: A single inhaled dose of placebo from a DPI
Forced Expiratory Volume in 1 Second (FEV1)	0.1 percentage of change from baseline Standard Error 0.6	3.2 percentage of change from baseline Standard Error 1.9	1.6 percentage of change from baseline Standard Error 1.8	3.2 percentage of change from baseline Standard Error 2.4	0.8 percentage of change from baseline Standard Error 2.8

Adverse Events

All Study Participants

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

Eliana Mendes

University of Miami

Phone: (305) 243-2568

Email: e.mendes@miami.edu

Results disclosure agreements

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