Trial · NCT02348203
Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers
NCT02348203, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-03-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers. Trials, record NCT02348203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02348203
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers
- NCT number
- NCT02348203
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 63 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Tobacco Use Disorder
- Interventions
- Aspirin, Laboratory Biomarker Analysis, Placebo Administration, Placebo Administration, Zileuton
- First posted
- 2015-01-28
- Last updated
- 2022-06-02
- Results first posted
- 2020-03-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in a Smoking-related Gene Expression Signature Score in the Nasal Epithelium of Current Smokers | Baseline to 12 weeks (End-of-intervention) | Change in a nasal smoking-related gene expression signature score derived from prior research was compared between the two study arms. Prior research showed that a higher score was observed in never smokers compared to current smokers. An increased score implicated a more favorable intervention effect. There is no minimum or maximum score. |
| Secondary | Changes in Three Lung Cancer Gene Signatures (an 80-gene Bronchial Signature, a PI3K Pathway Gene Signature and a Nasal Diagnostic Gene Signature) in the Nasal Epithelium of Current Smokers | Baseline to 12 weeks (End of Intervention) | Change in three lung cancer gene signatures (an 80-gene bronchial signature, a PI3K pathway gene signature and a nasal diagnostic gene signature) derived from prior research was compared between the two study arms. A decreased signature score implicated a more favorable intervention effect. There is no minimum or maximum score. |
| Secondary | Changes in a Smoking-related Gene Expression Signature Score in the Nasal Epithelium of Current Smokers 10-14 Days Post Intervention | Baseline to 14 days post intervention | Change (from baseline to 10-14 days off intervention) in a nasal smoking-related gene expression signature score derived from prior research was compared between the two study arms. Prior research showed that a higher score was observed in never smokers compared to current smokers. An increased score implicated a more favorable intervention effect. There is no minimum or maximum score. |
| Secondary | Changes in Three Lung Cancer Gene Signatures (an 80-gene Bronchial Signature, a PI3K Pathway Gene Signature and a Nasal Diagnostic Gene Signature) in the Nasal Epithelium of Current Smokers 10-14 Days Post Intervention | Baseline to 14 days post intervention | Change (from baseline to 10-14 days off intervention) in three lung cancer gene signatures (an 80-gene bronchial signature, a PI3K pathway gene signature and a nasal diagnostic gene signature) derived from prior research was compared between the two study arms. A decreased signature score implicated a more favorable intervention effect. There is no minimum or maximum score. |
| Secondary | Change in Urinary PGE-M Levels | Baseline to 12 weeks (End-of-intervention) | |
| Secondary | Change in Urinary LTE (4) Levels | Baseline to 12 weeks (End-of-intervention) | |
| Secondary | Number of Participants Experiencing Possibly/Probably/Definitely-related Adverse Events | Up to 2 weeks post-treatment | |
| Secondary | Gender Effect on Smoking-related Gene Expression Signature | Baseline to 12 weeks (End-of-intervention) | Change in a nasal smoking-related gene expression signature score derived from prior research was analyzed by gender. Prior research showed that a higher score was observed in never smokers compared to current smokers. An increased score implicated a more favorable intervention effect. There is no minimum or maximum score. |
| Secondary | Changes in the Metabolomics Profile of the Arachidonic Acid Pathway | Baseline to 12 weeks (End-of-intervention) | Two sample t tests will be performed to evaluate whether or not there are significant differences in changes in oxylipin metabolome between the treatment and placebo groups. In addition, system biology methods will also be used to analyze the oxylipin metabolome data. |
| Secondary | Number of Genes Differentially Expressed After Aspirin and Zileuton Intervention Compared to Placebo | Baseline to 12 weeks (End-of-intervention) | Number of genes differentially expressed after aspirin and zileuton intervention compared to placebo using whole-genome gene expression data |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in a Smoking-related Gene Expression Signature Score in the Nasal Epithelium of Current Smokers | Baseline to 12 weeks (End-of-intervention) | The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics. | score on a scale | MEAN |
| SECONDARY | Changes in Three Lung Cancer Gene Signatures (an 80-gene Bronchial Signature, a PI3K Pathway Gene Signature and a Nasal Diagnostic Gene Signature) in the Nasal Epithelium of Current Smokers | Baseline to 12 weeks (End of Intervention) | The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics. | score on a scale | MEAN |
| SECONDARY | Changes in a Smoking-related Gene Expression Signature Score in the Nasal Epithelium of Current Smokers 10-14 Days Post Intervention | Baseline to 14 days post intervention | The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics. | score on a scale | MEAN |
| SECONDARY | Changes in Three Lung Cancer Gene Signatures (an 80-gene Bronchial Signature, a PI3K Pathway Gene Signature and a Nasal Diagnostic Gene Signature) in the Nasal Epithelium of Current Smokers 10-14 Days Post Intervention | Baseline to 14 days post intervention | The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics. | score on a scale | MEAN |
| SECONDARY | Change in Urinary PGE-M Levels | Baseline to 12 weeks (End-of-intervention) | ng/mg creatinine | MEAN | |
| SECONDARY | Change in Urinary LTE (4) Levels | Baseline to 12 weeks (End-of-intervention) | pg/mg creatinine | MEAN | |
| SECONDARY | Number of Participants Experiencing Possibly/Probably/Definitely-related Adverse Events | Up to 2 weeks post-treatment | All participants who have received at least one dose of the study agent. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Gender Effect on Smoking-related Gene Expression Signature | Baseline to 12 weeks (End-of-intervention) | The number of participants analyzed is different from the numbers provided in the Participant Flow Module because gene expression analysis was restricted to samples that met quality metrics. | score on a scale | MEAN |
| SECONDARY | Changes in the Metabolomics Profile of the Arachidonic Acid Pathway | Baseline to 12 weeks (End-of-intervention) | Data were not collected. | ||
| SECONDARY | Number of Genes Differentially Expressed After Aspirin and Zileuton Intervention Compared to Placebo | Baseline to 12 weeks (End-of-intervention) | gene | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in a Smoking-related Gene Expression Signature Score in the Nasal Epithelium of Current Smokers | Arm I (Aspirin, Zileuton) | -0.15 | Standard Deviation 2.89 | score on a scale | |
| Changes in a Smoking-related Gene Expression Signature Score in the Nasal Epithelium of Current Smokers | Arm II (Double Placebo) | 0.26 | Standard Deviation 2.26 | score on a scale | |
| Changes in Three Lung Cancer Gene Signatures (an 80-gene Bronchial Signature, a PI3K Pathway Gene Signature and a Nasal Diagnostic Gene Signature) in the Nasal Epithelium of Current Smokers | Arm I (Aspirin, Zileuton) | bronchial smoking signature | -1.0 | Standard Deviation 2.87 | score on a scale |
| Changes in Three Lung Cancer Gene Signatures (an 80-gene Bronchial Signature, a PI3K Pathway Gene Signature and a Nasal Diagnostic Gene Signature) in the Nasal Epithelium of Current Smokers | Arm II (Double Placebo) | bronchial smoking signature | -0.43 | Standard Deviation 3.37 | score on a scale |
| Changes in Three Lung Cancer Gene Signatures (an 80-gene Bronchial Signature, a PI3K Pathway Gene Signature and a Nasal Diagnostic Gene Signature) in the Nasal Epithelium of Current Smokers | Arm I (Aspirin, Zileuton) | PI3 pathway gene signature | -0.32 | Standard Deviation 1.57 | score on a scale |
| Changes in Three Lung Cancer Gene Signatures (an 80-gene Bronchial Signature, a PI3K Pathway Gene Signature and a Nasal Diagnostic Gene Signature) in the Nasal Epithelium of Current Smokers | Arm II (Double Placebo) | PI3 pathway gene signature | 0.42 | Standard Deviation 1.68 | score on a scale |
| Changes in Three Lung Cancer Gene Signatures (an 80-gene Bronchial Signature, a PI3K Pathway Gene Signature and a Nasal Diagnostic Gene Signature) in the Nasal Epithelium of Current Smokers | Arm I (Aspirin, Zileuton) | nasal diagnostic gene signature | 1.82 | Standard Deviation 8.63 | score on a scale |
| Changes in Three Lung Cancer Gene Signatures (an 80-gene Bronchial Signature, a PI3K Pathway Gene Signature and a Nasal Diagnostic Gene Signature) in the Nasal Epithelium of Current Smokers | Arm II (Double Placebo) | nasal diagnostic gene signature | 2.17 | Standard Deviation 11.21 | score on a scale |
| Changes in a Smoking-related Gene Expression Signature Score in the Nasal Epithelium of Current Smokers 10-14 Days Post Intervention | Arm I (Aspirin, Zileuton) | -0.24 | Standard Deviation 3.04 | score on a scale | |
| Changes in a Smoking-related Gene Expression Signature Score in the Nasal Epithelium of Current Smokers 10-14 Days Post Intervention | Arm II (Double Placebo) | -1.16 | Standard Deviation 3.55 | score on a scale |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I (Aspirin, Zileuton) | 31 | |
| Overall Study | STARTED | Arm II (Double Placebo) | 32 | |
| Overall Study | COMPLETED | Arm I (Aspirin, Zileuton) | 21 | |
| Overall Study | COMPLETED | Arm II (Double Placebo) | 22 | |
| Overall Study | NOT COMPLETED | Arm I (Aspirin, Zileuton) | 10 | |
| Overall Study | NOT COMPLETED | Arm II (Double Placebo) | 10 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Arm I (Aspirin, Zileuton) | 2 | 31 | |
| other | Diarrhea | Gastrointestinal disorders | Arm II (Double Placebo) | 1 | 32 | |
| other | Dyspepsia | Gastrointestinal disorders | Arm I (Aspirin, Zileuton) | 5 | 31 | |
| other | Dyspepsia | Gastrointestinal disorders | Arm II (Double Placebo) | 4 | 32 | |
| other | Nausea | Gastrointestinal disorders | Arm I (Aspirin, Zileuton) | 2 | 31 | |
| other | Nausea | Gastrointestinal disorders | Arm II (Double Placebo) | 0 | 32 | |
| other | Vomiting | Gastrointestinal disorders | Arm I (Aspirin, Zileuton) | 2 | 31 | |
| other | Vomiting | Gastrointestinal disorders | Arm II (Double Placebo) | 0 | 32 | |
| other | Weight gain | Investigations | Arm I (Aspirin, Zileuton) | 3 | 31 | |
| other | Weight gain | Investigations | Arm II (Double Placebo) | 1 | 32 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I (Aspirin, Zileuton) | 0 | 31 |
| Total, all-cause mortality | Arm II (Double Placebo) | 0 | 32 |
| Total, other adverse events | Arm I (Aspirin, Zileuton) | 25 | 31 |
| Total, other adverse events | Arm II (Double Placebo) | 17 | 32 |
| Total, serious adverse events | Arm I (Aspirin, Zileuton) | 0 | 31 |
| Total, serious adverse events | Arm II (Double Placebo) | 0 | 32 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA023074 | University of Arizona Cancer Center - Cancer Center Support Grant | THEODORESCU, DAN | UNIVERSITY OF ARIZONA | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I (Aspirin, Zileuton) vs Arm II (Double Placebo): Number of Participants Experiencing Possibly/Probably/Definitely-related Adverse Events | Trial comparisons |
| Arm I (Aspirin, Zileuton) vs Arm II (Double Placebo): deaths from any cause | Trial comparisons |
| Arm I (Aspirin, Zileuton) vs Arm II (Double Placebo): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02348203
GET https://conductscience.org/api/trials/v1/NCT02348203/results?page=2