Trial · NCT03326063
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban
NCT03326063, Phase 2, Completed, Brigham and Women's Hospital; results first posted 2023-07-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban. Trials, record NCT03326063. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03326063
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban
- NCT number
- NCT03326063
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Nasal Polyps, Asthma, Aspirin-Induced, Aspirin-exacerbated Respiratory Disease, Aspirin-Sensitive Asthma With Nasal Polyps
- Interventions
- Ifetroban, Placebo
- First posted
- 2017-10-30
- Last updated
- 2023-07-14
- Results first posted
- 2023-07-14
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Provocative Dose 2 (PD2) During Aspirin Challenge | 6 weeks from screening visit ( at visit 2) | The calculated dose of aspirin that induces an increase in the Total Nasal Symptom Score (TNSS) of 2 from the pre-aspirin challenge value, "PD2" TNSS: A higher TNSS score suggests more severe symptoms, on a scale from 0-65 PD2: A higher PD2 suggests that the patient's threshold of reactivity of aspirin was higher |
| Secondary | Percentage Change From Baseline of FEV1 During Aspirin Challenge (Bronchoconstriction) | At Visit 2. The change in FEV1 from the morning baseline to the aspirin-induced lowest value in FEV1 during reaction to aspirin challenge later that same day. | Severity of bronchoconstriction during the aspirin-induced reaction at Visit 2, compared between patients on placebo vs ifetroban, with the changes also analyzed with provocative aspirin dose as a covariate. Measured by an aspirin-induced decrease in FEV1. |
| Secondary | Aspirin-induced Leukotriene E4 (LTE4) Levels | Visit 2. The change in LTE4 levels from the morning baseline to the aspirin-induced highest value in LTE4 during reaction to aspirin challenge that same day. | Increase of urinary levels of LTE4 during aspirin-induced reaction from Visit 2 pre-aspirin levels, compared between patients on placebo vs ifetroban, with the changes also analyzed with provocative aspirin dose as a covariate. LTE4 levels were calculated in a specialized laboratory. |
| Secondary | Change in Chronic Disease Control by Measurement of Lung Function Through FEV1 | 1 month (between Visit 1 and Visit 2) | Change from Visit 1 in baseline FEV1,compared between patients on placebo vs ifetroban. |
| Secondary | Change in Chronic Disease by Measurement of Asthma Control Through Asthma Control Questionnaire (ACQ) Score | 1 month (between Visit 1 and Visit 2) | Change from Visit 1 in baseline ACQ (Asthma Control Questionnaire) score, compared between patients on placebo vs ifetroban. ACQ is a patient-reported questionnaire measurement of asthma control from 0-6, where lower scores suggest better asthma control. The score is the average result of the answer choices picked by the patient. |
| Secondary | Clinical Improvement of Chronic Disease - Sino-Nasal Outcome Test (SNOT-22) Score | 1 month (between Visit 1 and Visit 2) | Change from Visit 1 in baseline SNOT-22 score at Visit 2, compared between patients on placebo vs ifetroban. The SNOT-22 is a patient-reported questionnaire with a summed scale that goes from 0-110 and a lower score suggests better sinonasal control. |
| Secondary | Fractional Exhaled Nitric Oxide (FeNO) | 1 month (between Visit 1 and Visit 2) | Change from Visit 1 in baseline FeNO levels at Visit 2, compared between patients on placebo vs ifetroban. |
| Other | Percent Change in Urinary Eicosanoid (TXB2 and LTE4) Levels | 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2) | Change in levels of other urinary eicosanoids,from Visit 1 to Visit 2 pre-aspirin challenge and Visit 2 pre-aspirin to during the aspirin-induced reaction at Visit 2, compared between patients on placebo vs ifetroban, with the changes also analyzed with provocative aspirin dose as a covariate. Measurements include urinary thromboxane B2 (TXB2) and LTE4. |
| Other | Nasal Eicosanoid Changes | 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2) | Change in levels of nasal eicosanoids, from Visit 1 to Visit 2 pre-aspirin challenge and Visit 2 pre-aspirin to during the aspirin-induced reaction at Visit 2, compared between patients on placebo vs ifetroban, with the changes also analyzed with provocative aspirin dose as a covariate. |
| Other | Plasma/Serum Tryptase Changes | 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2) | Change in levels of plasma/serum tryptase, from Visit 1 to Visit 2 pre-aspirin challenge and Visit 2 pre-aspirin to during the aspirin-induced reaction at Visit 2, compared between patients on placebo vs ifetroban, with the changes also analyzed with provocative aspirin dose as a covariate. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Provocative Dose 2 (PD2) During Aspirin Challenge | 6 weeks from screening visit ( at visit 2) | mg | MEAN | |
| SECONDARY | Percentage Change From Baseline of FEV1 During Aspirin Challenge (Bronchoconstriction) | At Visit 2. The change in FEV1 from the morning baseline to the aspirin-induced lowest value in FEV1 during reaction to aspirin challenge later that same day. | percentage change from baseline | MEAN | |
| SECONDARY | Aspirin-induced Leukotriene E4 (LTE4) Levels | Visit 2. The change in LTE4 levels from the morning baseline to the aspirin-induced highest value in LTE4 during reaction to aspirin challenge that same day. | ng/mg creatinine | MEAN | |
| SECONDARY | Change in Chronic Disease Control by Measurement of Lung Function Through FEV1 | 1 month (between Visit 1 and Visit 2) | percent change from baseline | MEAN | |
| SECONDARY | Change in Chronic Disease by Measurement of Asthma Control Through Asthma Control Questionnaire (ACQ) Score | 1 month (between Visit 1 and Visit 2) | scores on a scale | MEAN | |
| SECONDARY | Clinical Improvement of Chronic Disease - Sino-Nasal Outcome Test (SNOT-22) Score | 1 month (between Visit 1 and Visit 2) | scores on a scale | MEAN | |
| SECONDARY | Fractional Exhaled Nitric Oxide (FeNO) | 1 month (between Visit 1 and Visit 2) | parts per billion | MEAN | |
| OTHER_PRE_SPECIFIED | Percent Change in Urinary Eicosanoid (TXB2 and LTE4) Levels | 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2) | |||
| OTHER_PRE_SPECIFIED | Nasal Eicosanoid Changes | 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2) | |||
| OTHER_PRE_SPECIFIED | Plasma/Serum Tryptase Changes | 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2) |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Provocative Dose 2 (PD2) During Aspirin Challenge | Ifetroban | 121 | Standard Error 48 | mg | |
| Provocative Dose 2 (PD2) During Aspirin Challenge | Placebo | 142 | Standard Error 46 | mg | |
| Percentage Change From Baseline of FEV1 During Aspirin Challenge (Bronchoconstriction) | Ifetroban | -18.8 | Standard Deviation 3.6 | percentage change from baseline | |
| Percentage Change From Baseline of FEV1 During Aspirin Challenge (Bronchoconstriction) | Placebo | -8.4 | Standard Deviation 2.1 | percentage change from baseline | |
| Aspirin-induced Leukotriene E4 (LTE4) Levels | Ifetroban | 0.72 | Standard Deviation 0.30 | ng/mg creatinine | |
| Aspirin-induced Leukotriene E4 (LTE4) Levels | Placebo | 0.15 | Standard Deviation 0.10 | ng/mg creatinine | |
| Change in Chronic Disease Control by Measurement of Lung Function Through FEV1 | Ifetroban | -0.2 | Standard Deviation 1.3 | percent change from baseline | |
| Change in Chronic Disease Control by Measurement of Lung Function Through FEV1 | Placebo | -0.5 | Standard Deviation 1.2 | percent change from baseline | |
| Change in Chronic Disease by Measurement of Asthma Control Through Asthma Control Questionnaire (ACQ) Score | Ifetroban | 0.17 | Standard Deviation 0.16 | scores on a scale | |
| Change in Chronic Disease by Measurement of Asthma Control Through Asthma Control Questionnaire (ACQ) Score | Placebo | -0.03 | Standard Deviation 0.11 | scores on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ifetroban | 18 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | COMPLETED | Ifetroban | 17 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | NOT COMPLETED | Ifetroban | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events32
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 | Upper Respiratory Tract Infection/Sinusitis, Grade 2 | Respiratory, thoracic and mediastinal disorders | Placebo | 2 | 18 | 2 |
| other | Upper Respiratory Tract Infection/Sinusitis, Grade 2 | Respiratory, thoracic and mediastinal disorders | Ifetroban | 0 | 18 | 0 |
| other | Pregnant partner | Pregnancy, puerperium and perinatal conditions | Placebo | 1 | 18 | 1 |
| other | Pregnant partner | Pregnancy, puerperium and perinatal conditions | Ifetroban | 0 | 18 | 0 |
| other | Rash, maculo-papular, Grade 1 | Skin and subcutaneous tissue disorders | Placebo | 2 | 18 | 2 |
| other | Rash, maculo-papular, Grade 1 | Skin and subcutaneous tissue disorders | Ifetroban | 0 | 18 | 0 |
| other | Ear Pain, Grade 1 | Ear and labyrinth disorders | Placebo | 1 | 18 | 1 |
| other | Ear Pain, Grade 1 | Ear and labyrinth disorders | Ifetroban | 0 | 18 | 0 |
| other | Stomach Pain, Grade 1 | Gastrointestinal disorders | Placebo | 1 | 18 | 1 |
| other | Stomach Pain, Grade 1 | Gastrointestinal disorders | Ifetroban | 0 | 18 | 0 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 18 |
| Total, all-cause mortality | Ifetroban | 0 | 18 |
| Total, other adverse events | Placebo | 11 | 18 |
| Total, other adverse events | Ifetroban | 12 | 18 |
| Total, serious adverse events | Placebo | 0 | 18 |
| Total, serious adverse events | Ifetroban | 0 | 18 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ifetroban vs Placebo: deaths from any cause | Trial comparisons |
| Ifetroban vs 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/NCT03326063
GET https://conductscience.org/api/trials/v1/NCT03326063/events?page=2