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Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers

Primary Purpose

Tobacco Use Disorder, Smoking

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Aspirin 325 mg daily

Celecoxib 200 mg BID

About this trial

This is an interventional prevention trial for Tobacco Use Disorder

Eligibility Criteria

35 Years - 90 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Male gender
Age ≥35
Current smoker of at least 10 cigarettes per day with history of ≥10 pack-years (py)
Former smoker, quit no more than 15 years ago with a history of at least 25 py
Ability to comply with the design of the study
Capacity to freeze urine sample at participant's residence if this participant desires to store the urine specimens in this manner
Baseline urine PGE-M > 13 ng/mg creatinine
Serum thromboxane > 150 μg/L

Exclusion Criteria:

History of aspirin use 1-14 days prior to screening
NSAID (ibuprofen, naprosyn, meloxicam, etc) use 1-7 days prior to screening
Inhaled glucocorticoid use 1-7 days prior to screening
Systemic glucocorticoid use 1-14 days prior to screening
History of peptic ulcer disease
Current or recent clinically significant bleeding
Allergy, intolerance or contraindication to aspirin or NSAID use
Thrombocytopenia (platelet count < 100,000) in 30 days prior to screening visit
Severe hepatic insufficiency
GFR < 30 mL/min/1.73 m2 in 30 days prior to screening visit
History of aspirin or celecoxib allergy
Elevated INR (>1.5) in 30 days prior to screening visit
Current diagnosis of malignancy or history of non-skin malignancy in last 5 years
Current use of systemic anticoagulants (e.g., warfarin (Coumadin), enoxaparin (Lovenox), Fondaparinux (Arixtra), dabigatran (Pradaxa))
Diagnosis of COPD
Intake of > 250 mg of fish oil supplementation daily

Sites / Locations

Vanderbilt University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Celecoxib, aspirin, followed by aspirin/celecoxib

Arm Description

Celecoxib 200 mg twice daily x3 days, aspirin 325 mg daily x10 days, celecoxib 200 mb twice daily + aspirin 325 mg daily x 3 days

Outcomes

Primary Outcome Measures

Change in COX-2 dependent urinary PGE-M (ng/mg Cr) production after 16 days of aspirin treatment

Baseline urinary PGE-2 metabolite (PGE-M) will be measured. Then after 3 days of COX-2 blockade with celecoxib, it will again be measured. Participants will then undergo 10 days of treatment with aspirin and urinary PGE-M will be measured. Finally, participants will be treated with combined aspirin and celecoxib for 3 days and urinary PGE-M will be measured one last time. Using these values, the degree of aspirin inhibition of COX-2 specific urinary PGE-M production can be calculated.

Secondary Outcome Measures

Full Information

NCT ID

NCT01796951

First Posted

February 14, 2013

Last Updated

March 30, 2017

Sponsor

Vanderbilt University

1. Study Identification

Unique Protocol Identification Number

NCT01796951

Brief Title

Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers

Official Title

Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

February 2013 (Actual)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Regular aspirin use has been associated with a reduction in the development of a number of different malignancies including lung cancer. The mechanism of aspirin's cancer prevention is not known. This study will evaluate whether once daily aspirin use can reduce the production of a protein named prostaglandin E2 (PGE-2), which is known to promote cancer. Specifically, this study will evaluate if aspirin can inhibit the production of PGE-2 by blocking an enzyme named cycloxygenase-2 (COX-2). To accomplish these goals, participants will take either aspirin 325 mg daily, celecoxib 200 mg twice daily, or the combination of both during various days of this 16-day study. Urine be collected to evaluate for PGE-2 production at 4 timepoints in this 16-day study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Use Disorder, Smoking

7. Study Design

Primary Purpose

Prevention

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Celecoxib, aspirin, followed by aspirin/celecoxib

Arm Type

Experimental

Arm Description

Celecoxib 200 mg twice daily x3 days, aspirin 325 mg daily x10 days, celecoxib 200 mb twice daily + aspirin 325 mg daily x 3 days

Intervention Type

Drug

Intervention Name(s)

Aspirin 325 mg daily

Intervention Description

In this single-arm trial, participants will take celecoxib 200 mg BID for 5 doses, followed by aspirin 325 mg daily for 10 days, followed by combination of celecoxib 200 mg BID for 5 doses and aspirin 325 mg daily for 3 days.

Intervention Type

Drug

Intervention Name(s)

Celecoxib 200 mg BID

Intervention Description

Primary Outcome Measure Information:

Title

Change in COX-2 dependent urinary PGE-M (ng/mg Cr) production after 16 days of aspirin treatment

Description

Time Frame

16 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male gender Age ≥35 Current smoker of at least 10 cigarettes per day with history of ≥10 pack-years (py) Former smoker, quit no more than 15 years ago with a history of at least 25 py Ability to comply with the design of the study Capacity to freeze urine sample at participant's residence if this participant desires to store the urine specimens in this manner Baseline urine PGE-M > 13 ng/mg creatinine Serum thromboxane > 150 μg/L Exclusion Criteria: History of aspirin use 1-14 days prior to screening NSAID (ibuprofen, naprosyn, meloxicam, etc) use 1-7 days prior to screening Inhaled glucocorticoid use 1-7 days prior to screening Systemic glucocorticoid use 1-14 days prior to screening History of peptic ulcer disease Current or recent clinically significant bleeding Allergy, intolerance or contraindication to aspirin or NSAID use Thrombocytopenia (platelet count < 100,000) in 30 days prior to screening visit Severe hepatic insufficiency GFR < 30 mL/min/1.73 m2 in 30 days prior to screening visit History of aspirin or celecoxib allergy Elevated INR (>1.5) in 30 days prior to screening visit Current diagnosis of malignancy or history of non-skin malignancy in last 5 years Current use of systemic anticoagulants (e.g., warfarin (Coumadin), enoxaparin (Lovenox), Fondaparinux (Arixtra), dabigatran (Pradaxa)) Diagnosis of COPD Intake of > 250 mg of fish oil supplementation daily

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John A Oates, MD

Organizational Affiliation

Vanderbilt University

Official's Role

Study Director

Facility Information:

Facility Name

Vanderbilt University

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

12. IPD Sharing Statement

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Low Dose Aspirin Inhibition of COX-2 Derived PGE2 in Male Smokers

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