A Phase 2 interventional study of Ifetroban and Placebo in Nasal Polyps, Asthma, Aspirin-Induced and Aspirin-exacerbated Respiratory Disease, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-14.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment
The overall aim of the study is to determine the efficacy of oral ifetroban, a novel antagonist of T prostanoid (TP) receptors, as a treatment for patients with aspirin-exacerbated respiratory disease (AERD).
The protocol involves a 4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban in patients with AERD. At the end of the 4-week treatment phase (ifetroban or placebo) each subject will undergo a graded oral aspirin desensitization procedure in order to initiate high-dose aspirin therapy, which is standard-of-care at our institution and is the only available therapy known to modify the course of AERD.
236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.
This study's enrollment of 38 is below the median of 60 across 181 interventional studies indexed under Nasal Polyps.
Browse Nasal Polyps studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
History of AERD, defined as meeting the diagnostic triad with:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be randomized to receive ifetroban (200 mg dose per day) for 4 weeks.
Drug: Ifetroban
Subjects will be randomized to receive placebo for 4 weeks.
Drug: Placebo
4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD
Also known as: ifetroban sodium
4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD
Provocative Dose 2 (PD2) During Aspirin Challenge
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
Time frame: 6 weeks from screening visit ( at visit 2)
Percentage Change From Baseline of FEV1 During Aspirin Challenge (Bronchoconstriction)
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.
Time frame: 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.
Aspirin-induced Leukotriene E4 (LTE4) Levels
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.
Time frame: 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.
Change in Chronic Disease Control by Measurement of Lung Function Through FEV1
Change from Visit 1 in baseline FEV1,compared between patients on placebo vs ifetroban.
Time frame: 1 month (between Visit 1 and Visit 2)
Change in Chronic Disease by Measurement of Asthma Control Through Asthma Control Questionnaire (ACQ) Score
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.
Time frame: 1 month (between Visit 1 and Visit 2)
Clinical Improvement of Chronic Disease - Sino-Nasal Outcome Test (SNOT-22) Score
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.
Time frame: 1 month (between Visit 1 and Visit 2)
Fractional Exhaled Nitric Oxide (FeNO)
Change from Visit 1 in baseline FeNO levels at Visit 2, compared between patients on placebo vs ifetroban.
Time frame: 1 month (between Visit 1 and Visit 2)
Percent Change in Urinary Eicosanoid (TXB2 and LTE4) Levels
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.
Time frame: 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2)
Nasal Eicosanoid Changes
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.
Time frame: 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2)
Plasma/Serum Tryptase Changes
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.
Time frame: 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2)
Nasal Tryptase Changes
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.
Time frame: 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2)
Platelet Activation - Numbers of Activated Platelets
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.
Time frame: 1 month (between Visit 1 and Visit 2) and during aspirin challenge visit
Platelet Activation - Percentages of Activated Platelets
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.
Time frame: 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2)
Platelet Activation - Numbers of Platelet-leukocyte Aggregates
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.
Time frame: 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2)
Platelet Activation - Percentages of Platelet-leukocyte Aggregates
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.
Time frame: 1 month (between Visit 1 and Visit 2) and 6 weeks from screening visit ( at visit 2)
A total of 38 potential participants were screened at Brigham and Women's Hospital.
| Milestone | Ifetroban | Placebo |
|---|---|---|
| Started | 18 | 18 |
| Completed | 17 | 18 |
| Not completed | 1 | 0 |
| Withdrew: Covid pandemic: subject recalled to her country | 1 | 0 |
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
| mg | Ifetroban | Placebo |
|---|---|---|
| Provocative Dose 2 (PD2) During Aspirin Challenge | 121 ± 48 | 142 ± 46 |
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.
| percentage change from baseline | Ifetroban | Placebo |
|---|---|---|
| Percentage Change From Baseline of FEV1 During Aspirin Challenge (Bronchoconstriction) | -18.8 ± 3.6 | -8.4 ± 2.1 |
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.
| ng/mg creatinine | Ifetroban | Placebo |
|---|---|---|
| Aspirin-induced Leukotriene E4 (LTE4) Levels | 0.72 ± 0.30 | 0.15 ± 0.10 |
Change from Visit 1 in baseline FEV1,compared between patients on placebo vs ifetroban.
| percent change from baseline | Ifetroban | Placebo |
|---|---|---|
| Change in Chronic Disease Control by Measurement of Lung Function Through FEV1 | -0.2 ± 1.3 | -0.5 ± 1.2 |
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.
| scores on a scale | Ifetroban | Placebo |
|---|---|---|
| Change in Chronic Disease by Measurement of Asthma Control Through Asthma Control Questionnaire (ACQ) Score | 0.17 ± 0.16 | -0.03 ± 0.11 |
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.
| scores on a scale | Ifetroban | Placebo |
|---|---|---|
| Clinical Improvement of Chronic Disease - Sino-Nasal Outcome Test (SNOT-22) Score | 1.5 ± 3.0 | -2.0 ± 2.3 |
Change from Visit 1 in baseline FeNO levels at Visit 2, compared between patients on placebo vs ifetroban.
| parts per billion | Ifetroban | Placebo |
|---|---|---|
| Fractional Exhaled Nitric Oxide (FeNO) | 7.9 ± 9.0 | -3.4 ± 3.0 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over Adverse events were reported from the time of randomized subject enrollment through study completion, about 8 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/18 (0%) | 0/18 (0%) | 11/18 (61.1%) |
| Ifetroban | 0/18 (0%) | 0/18 (0%) | 12/18 (66.7%) |
| Event | Placebo | Ifetroban |
|---|---|---|
| Systemic reaction to aspirin challenge with extrapulmonary symptomsInjury, poisoning and procedural complications | 2/18 | 3/18 |
| Upper Respiratory Tract Infection/Sinusitis, Grade 2Respiratory, thoracic and mediastinal disorders | 2/18 | 0/18 |
| Rash, maculo-papular, Grade 1Skin and subcutaneous tissue disorders | 2/18 | 0/18 |
| Wheezing, Grade 1Respiratory, thoracic and mediastinal disorders | 0/18 | 2/18 |
| Pregnant partnerPregnancy, puerperium and perinatal conditions | 1/18 | 0/18 |
| Ear Pain, Grade 1Ear and labyrinth disorders | 1/18 | 0/18 |
| Stomach Pain, Grade 1Gastrointestinal disorders | 1/18 | 0/18 |
| Eye disorder- Stye, Grade 1Eye disorders | 0/18 | 1/18 |
| Lung Infection (influenza B-related pneumonia), Grade 2Infections and infestations | 0/18 | 1/18 |
| Sinus disorder (bloody nose), Grade 1Blood and lymphatic system disorders | 0/18 | 1/18 |
| Age, Categorical(Participants) | Ifetroban | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 18 | 17 | 35 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Ifetroban | Placebo | Total |
|---|---|---|---|
| Female | 11 | 7 | 18 |
| Male | 7 | 11 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Ifetroban | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 16 | 16 | 32 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Ifetroban | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 16 | 16 | 32 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Ifetroban | Placebo | Total |
|---|---|---|---|
| United States | 18 | 18 | 36 |
| Provocative Dose 2 (PD2) During Aspirin Challenge(mg) | Ifetroban | Placebo | Total |
|---|---|---|---|
| Mean | 121 ± 48 | 142 ± 46 | 132 ± 47 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Ifetroban
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