Trial Outcomes & Findings for Single Dose Bronchodilatory Study in Asthma (NCT NCT01805687)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

12 Hours

Results posted on

2014-09-03

Participant Flow

Participant milestones

Participant milestones
Measure	Zileuton Extended Release Zileuton extended release 1200 mg (2 x 600 mg tablets)
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Dose Bronchodilatory Study in Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zileuton Extended Release n=25 Participants Zileuton extended release
Age, Continuous	35 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Hours

Outcome measures

Outcome measures
Measure	Zileuton Extended Release n=25 Participants Zileuton extended release
Change From Baseline in FEV1	2.84 Liter Standard Deviation 0.706

SECONDARY outcome

Timeframe: 72 Hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 Hours

Outcome measures

Outcome data not reported

Adverse Events

Zileuton Extended Release

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Zileuton Extended Release n=25 participants at risk Zileuton extended release
Hepatobiliary disorders Abnormal Liver Function	12.0% 3/25 • Number of events 3

Additional Information

W. James Alexander, MD, MPH

Cornerstone Therapeutics, Inc.

Phone: 919-678-6925

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60