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CompletedNCT00379808Updated Jul 23, 2012Results posted

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

An interventional study of montelukast and Placebo in Coronary Heart Disease, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-23.

Sponsored by University of Florida · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether a particular substance involved in inflammation, called leukotrienes, is involved in causing heart disease to occur or to progress.

Read the detailed description

The focus of this study is to better understand why some adults develop heart disease and others do not. There are many known factors which play a role in causing heart disease, such as diet and lifestyle. Also, we know that inflammation, a process in the body which causes painful joints in arthritis or swelling at a site if injury, also contributes to heart disease. In particular, we will address whether leukotrienes, a component of inflammation, is involved in promoting heart disease. We will study this by giving subjects at high risk for heart disease a drug called montelukast which causes leukotrienes to have a reduced effect in the body. In addition for comparison, we will give other subjects a placebo for the same amount of time. These subjects will then be crossed-over and will receive either montelukast or placebo depending on which treatment they received first. We will compare these subjects using blood tests to see if subjects who take montelukast show signs of less inflammation caused by early heart disease as compared to subjects who do not.

02

Conditions studied

  • Coronary Heart Disease

Keywords

  • coronary heart disease
  • montelukast
  • inflammation
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 22 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

-Current hypertension (blood pressure > 140/90 mmHg) or current use of anti-hypertensive medications AND

Exclusion criteria

Exclusion Criteria:

  • Current use of lipid-lowering medications
  • Current use of montelukast
  • Poorly controlled hypertension, where systolic blood pressure is greater than 160 or diastolic blood pressure is greater than 100
  • Use of steroid drugs, non-steroidal anti-inflammatory drugs or other anti-inflammatory medications in the two weeks prior to enrollment. (low dose aspirin ( \< 325 mg) is OK, but indication must be cardiovascular)
  • Current recreational drug use
  • Other cardiovascular disease or previous cardiovascular event. These include:
  • history of angina pectoris
  • history of heart failure
  • presence of a cardiac pacemaker
  • history of myocardial infarction
  • previous revascularization procedure
  • history cerebrovascular disease including stroke and transient ischemic attack
  • Pregnancy or lactation
  • Diabetes mellitus
  • Lactose intolerance
  • Contraindications to montelukast therapy
  • Alcoholism
  • Known hepatic disease
  • Existing chronic obstructive pulmonary disease, asthma, allergic rhinitis
  • Active chronic immune, infectious, neoplastic or inflammatory diseases requiring therapy (such as active Hepatitis B, Hepatitis C, human immunodeficiency virus (HIV))
  • Immunosuppressant therapy or known immunosuppression due to disease high density lipoprotein (HDL) \< 40 mg/dL (although this would be a risk factor for heart disease, because of preliminary data which indicates that montelukast may lower HDL levels, we will exclude patients with abnormally low HDL from study)
  • Other criteria at investigator discretion that are deemed to make the subject a poor candidate for the study
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
22 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    1 lactose-containing capsule daily for 1 month

    Drug: Placebo

  • Active comparator
    Montelukast 10 mg

    1 montelukast 10 mg tablet (masked by capsule) daily for 1 month

    Drug: montelukast

Interventions

  • Drugmontelukast

    10 mg tablet (masked by capsule) daily for 1 month

    Also known as: Singulair

  • DrugPlacebo

    1 lactose-containing capsule daily for 1 month

06

What researchers measure

Primary outcomes

  1. High-sensitivity C-reactive Protein

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

    Time frame: 1 month

Secondary outcomes

  1. High Density Lipoprotein (HDL)-Cholesterol

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

    Time frame: 1 month

Other outcomes

  1. Triglycerides

    measured by a clinical laboratory; Quest Laboratories

    Time frame: 1 month

  2. Monocyte Chemotactic Protein-1 (MCP-1)

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

    Time frame: 1 month

  3. Interleukin 1 Receptor Antagonist (IL1ra)

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

    Time frame: 1 month

  4. Epithelial Cell-derived Neutrophil-activating Peptide 78 (ENA-78)

    biomarker determined by enzyme-linked immunosorbant assay.

    Time frame: 1 month

07

Results

Posted Jul 23, 2012
Limitations and caveats
Because there were no order effects, the placebo groups were combined and the montelukast groups were combined. Therefore results from each of these are not reported by arm.

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

Intervention Period 1 (4 Weeks)
Participant flow — Intervention Period 1 (4 Weeks)
MilestonePlacebo Then MontelukastMontelukast Then Placebo
Started1111
Completed1111
Not completed00
Intervention Period 2 (4 Weeks)
Participant flow — Intervention Period 2 (4 Weeks)
MilestonePlacebo Then MontelukastMontelukast Then Placebo
Started1111
Completed1110
Not completed01
Withdrew: Lost to follow-up01

Outcome measures

PrimaryHigh-sensitivity C-reactive Protein

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

Time frame:
1 month
Reported as:
Median · mg/dl
High-sensitivity C-reactive Protein
mg/dlPlaceboMontelukast
High-sensitivity C-reactive Protein1.0 (0.6 to 5.4)1.0 (0.5 to 8.3)
Statistical analysis
  • Placebo vs Montelukast · Wilcoxon sign rank test · p = 0.22 · Median difference (net): 0
SecondaryHigh Density Lipoprotein (HDL)-Cholesterol

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

Time frame:
1 month
Reported as:
Median · mg/dl
High Density Lipoprotein (HDL)-Cholesterol
mg/dlPlaceboMontelukast
High Density Lipoprotein (HDL)-Cholesterol52 (46 to 68)50 (45 to 65)
Statistical analysis
  • Placebo vs Montelukast · Wilcoxon sign rank · p = 0.57 · Percent difference: 3.8
Other pre-specifiedTriglycerides

measured by a clinical laboratory; Quest Laboratories

Time frame:
1 month
Reported as:
Median · mg/dl
Triglycerides
mg/dlPlaceboMontelukast
Triglycerides94 (75 to 129)104 (73 to 139)
Statistical analysis
  • Placebo vs Montelukast · wilcoxon sign rank · p = 0.33 · Percent difference: 7.4
Other pre-specifiedMonocyte Chemotactic Protein-1 (MCP-1)

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

Time frame:
1 month
Reported as:
Median · pg/ml
Monocyte Chemotactic Protein-1 (MCP-1)
pg/mlPlaceboMontelukast
Monocyte Chemotactic Protein-1 (MCP-1)84 (72 to 105)94 (77 to 110)
Statistical analysis
  • Placebo vs Montelukast · Wilcoxon · p = 0.12 · Percent difference: 11.9
Other pre-specifiedInterleukin 1 Receptor Antagonist (IL1ra)

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

Time frame:
1 month
Reported as:
Median · pg/ml
Interleukin 1 Receptor Antagonist (IL1ra)
pg/mlPlaceboMontelukast
Interleukin 1 Receptor Antagonist (IL1ra)518 (400 to 828)587 (429 to 1240)
Statistical analysis
  • Placebo vs Montelukast · wilcoxon sign rank test · p = 0.03 · Percent difference: 13.3
Other pre-specifiedEpithelial Cell-derived Neutrophil-activating Peptide 78 (ENA-78)

biomarker determined by enzyme-linked immunosorbant assay.

Time frame:
1 month
Reported as:
Median · pg/ml
Epithelial Cell-derived Neutrophil-activating Peptide 78 (ENA-78)
pg/mlPlaceboMontelukast
Epithelial Cell-derived Neutrophil-activating Peptide 78 (ENA-78)631 (441 to 1190)527 (175 to 1060)
Statistical analysis
  • Placebo vs Montelukast · wilcoxon sign rank · p = 0.09 · Percent difference: 16.5

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/21 (0%)0/21 (0%)
Montelukast—0/22 (0%)0/22 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)All Participants
<=18 years0
Between 18 and 65 years22
>=65 years0
Age Continuous
Age Continuous(years)All Participants
All study participants50.8 ± 12.5
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female13
Male9
Region of Enrollment
Region of Enrollment(participants)All Participants
United States22
08

Study locations

1 site
  • University of Florida Family Practice Medical Group Clinic
    Gainesville, Florida 32601, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00379808
Lead sponsor
University of Florida
Collaborators
American Heart Association
Responsible party
Sponsor
First posted
Sep 22, 2006
Start date
Jul 2006
Primary completion
Jul 2009
Completion
Aug 2009
Results posted
Jul 23, 2012
Last update
Jul 23, 2012

Study contacts

Julie A Johnson, PharmD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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