Trial · NCT03326063
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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. |
| Other | Nasal Tryptase Changes | 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2) | Change in levels of nasal 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. |
| Other | Platelet Activation - Numbers of Activated Platelets | 1 month (between Visit 1 and Visit 2) and during aspirin challenge visit | Change in numbers of activated platelets in the peripheral blood from Visit 1 to Visit 2 baseline (pre-aspirin administration) and during the aspirin-induced reaction at Visit 2 from Visit 2 baseline, compared between patients on placebo vs ifetroban, with the changes also analyzed with provocative aspirin dose as a covariate. |
| Other | Platelet Activation - Percentages of Activated Platelets | 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2) | Change in percentages of activated platelets in the peripheral blood from Visit 1 to Visit 2 baseline (pre-aspirin administration) and during the aspirin-induced reaction at Visit 2 from Visit 2 baseline, compared between patients on placebo vs ifetroban, with the changes also analyzed with provocative aspirin dose as a covariate. |
| Other | Platelet Activation - Numbers of Platelet-leukocyte Aggregates | 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2) | Change in numbers of platelet-leukocyte aggregates in the peripheral blood from Visit 1 to Visit 2 baseline (pre-aspirin administration) and during the aspirin-induced reaction at Visit 2 from Visit 2 baseline, compared between patients on placebo vs ifetroban, with the changes also analyzed with provocative aspirin dose as a covariate. |
| Other | Platelet Activation - Percentages of Platelet-leukocyte Aggregates | 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2) | Change in percentages of platelet-leukocyte aggregates in the peripheral blood from Visit 1 to Visit 2 baseline (pre-aspirin administration) and during the aspirin-induced reaction at Visit 2 from Visit 2 baseline, compared between patients on placebo vs ifetroban, with the changes also analyzed with provocative aspirin dose as a covariate. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT03326063/registered