Trial Outcomes & Findings for Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease (NCT NCT00379808)

NCT ID: NCT00379808

Last Updated: 2012-07-23

Results Overview

measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2012-07-23

Participant Flow

Patients were recruited based on flyers posted in public places, through recontact of patients in previous studies, and patients cared for in a family medicine clinic

Participant milestones

Measure	Placebo Then Montelukast Patients were randomized in a crossover design to placebo or montelukast. Patients int this randomization arm received 4 weeks of placebo then 4 weeks of montelukast. There was no washout between crossover	Montelukast Then Placebo Patients were randomized in a crossover design to placebo or montelukast. Patients in this arm got montelukast for 4 weeks and then placebo for 4 weeks. There was no washout period
Intervention Period 1 (4 Weeks) STARTED	11	11
Intervention Period 1 (4 Weeks) COMPLETED	11	11
Intervention Period 1 (4 Weeks) NOT COMPLETED	0	0
Intervention Period 2 (4 Weeks) STARTED	11	11
Intervention Period 2 (4 Weeks) COMPLETED	11	10
Intervention Period 2 (4 Weeks) NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Placebo Then Montelukast Patients were randomized in a crossover design to placebo or montelukast. Patients int this randomization arm received 4 weeks of placebo then 4 weeks of montelukast. There was no washout between crossover	Montelukast Then Placebo Patients were randomized in a crossover design to placebo or montelukast. Patients in this arm got montelukast for 4 weeks and then placebo for 4 weeks. There was no washout period
Intervention Period 2 (4 Weeks) Lost to Follow-up	0	1

Baseline Characteristics

Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease

Baseline characteristics by cohort

Measure	All Participants n=22 Participants Patients were randomized in a crossover design, but baseline characteristics were presented for all participants. Likewise data are not separated by order of treatment because there were no order effects
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous All study participants	50.8 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: based on patients who completed the entire study

measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)

Outcome measures

Measure	Placebo n=21 Participants This is all participants who received placebo, whether in first or second intervention	Montelukast n=21 Participants This is all patients who received montelukast, whether in the first or second intervention period
High-sensitivity C-reactive Protein	1.0 mg/dl Interval 0.6 to 5.4	1.0 mg/dl Interval 0.5 to 8.3

SECONDARY outcome

Timeframe: 1 month

Population: those completing entire study

Lipid levels were determined at a clinical laboratory (Quest Diagnostics)

Outcome measures

Measure	Placebo n=21 Participants This is all participants who received placebo, whether in first or second intervention	Montelukast n=21 Participants This is all patients who received montelukast, whether in the first or second intervention period
High Density Lipoprotein (HDL)-Cholesterol	52 mg/dl Interval 46.0 to 68.0	50 mg/dl Interval 45.0 to 65.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

Population: those completing the entire study

measured by a clinical laboratory; Quest Laboratories

Outcome measures

Measure	Placebo n=21 Participants This is all participants who received placebo, whether in first or second intervention	Montelukast n=21 Participants This is all patients who received montelukast, whether in the first or second intervention period
Triglycerides	94 mg/dl Interval 75.0 to 129.0	104 mg/dl Interval 73.0 to 139.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

Population: those who completed the entire study

biomarker was measured by enzyme-linked immunosorbant assay (ELISA)

Outcome measures

Measure	Placebo n=21 Participants This is all participants who received placebo, whether in first or second intervention	Montelukast n=21 Participants This is all patients who received montelukast, whether in the first or second intervention period
Monocyte Chemotactic Protein-1 (MCP-1)	84 pg/ml Interval 72.0 to 105.0	94 pg/ml Interval 77.0 to 110.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

Population: all participants who completed the entire study

IL1ra was determined by enzyme-linked immunosorbant assay (ELISA)

Outcome measures

Measure	Placebo n=21 Participants This is all participants who received placebo, whether in first or second intervention	Montelukast n=21 Participants This is all patients who received montelukast, whether in the first or second intervention period
Interleukin 1 Receptor Antagonist (IL1ra)	518 pg/ml Interval 400.0 to 828.0	587 pg/ml Interval 429.0 to 1240.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

Population: those completing the entire study

biomarker determined by enzyme-linked immunosorbant assay.

Outcome measures

Measure	Placebo n=21 Participants This is all participants who received placebo, whether in first or second intervention	Montelukast n=21 Participants This is all patients who received montelukast, whether in the first or second intervention period
Epithelial Cell-derived Neutrophil-activating Peptide 78 (ENA-78)	631 pg/ml Interval 441.0 to 1190.0	527 pg/ml Interval 175.0 to 1060.0

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Montelukast

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 Julie Johnson, PI

University of Florida

Phone: 352-273-6007

Email: johnson@cop.ufl.edu

Results disclosure agreements

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