Nasal PolypsPhase 2NCT03326063
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease With Ifetroban
A Phase 2 study testing Ifetroban in people with Nasal Polyps and Asthma, Aspirin-Induced, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasal Polyps, Asthma, Aspirin-Induced, Aspirin-exacerbated Respiratory Disease
- What is being tested?
- Ifetroban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2018to 15 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of AERD, defined as meeting the diagnostic triad with:
- History of physician-diagnosed asthma and
- History of physician-diagnosed nasal polyposis and
- History of pathognomonic reactions aspirin or other nonselective cyclooxygenase (COX) inhibitors.
- Stable asthma (post-bronchodilator forced expiratory volume at one second (FEV1) of ≥70%, no glucocorticoid burst for at least 2 weeks prior to Visit 1, and no hospitalizations or ER visits for asthma for at least the prior 6 months)
- Age between 18 and 70 years
- No current smoking (not more than one instance of smoking in the last 3 months)
- Non-pregnant
Who cannot join
- Hypersensitivity to montelukast
- Current use of zileuton
- History of bleeding diathesis or use of anticoagulant or antiplatelet drugs
- Current use of any NSAIDs aside from the aspirin provided during the study
- Current use of beta blockers
- Use of any biologics within the last 4 months prior to initiating the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Asthma Research Center, Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Therapeutic Control of Aspirin-Exacerbated Respiratory Disease
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).
Read the detailed description
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.
- Conditions
- Nasal Polyps, Asthma, Aspirin-Induced, Aspirin-exacerbated Respiratory Disease, Aspirin-Sensitive Asthma With Nasal Polyps
- Being tested
- Ifetroban, Placebo
- Medical subject headings
- Nasal Polyps, Asthma, Aspirin-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IfetrobanDrug
Also called ifetroban sodium
4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD
PlaceboDrug
4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD
| Study group | Role | What they receive |
|---|---|---|
| Ifetroban | Active comparator | Subjects will be randomized to receive ifetroban (200 mg dose per day) for 4 weeks. Receives: Drug: Ifetroban |
| Placebo | Placebo comparator | Subjects will be randomized to receive placebo for 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks from screening visit ( at visit 2)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 month (between Visit 1 and Visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start26 Apr 2018
- Primary completion30 Mar 2022
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elliot Israel, MD, Brigham and Women's Hospital
- Investigators
- Elliot Israel, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326063
- Sponsor's protocol ID
- 2017P001523
- Status last verified
- Jun 2023
- First submitted
- 16 Aug 2017
- Last updated
- 14 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Control of Aspirin-Exacerbated Respiratory Disease
- ClinicalTrials.gov ID
- NCT03326063
- Acronym / sponsor ID
- 2017P001523
- Conditions
- Nasal Polyps, Asthma, Aspirin-Induced, Aspirin-exacerbated Respiratory Disease, Aspirin-Sensitive Asthma With Nasal Polyps
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Posted 14 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ifetroban | Active comparator | Drug: IfetrobanSubjects will be randomized to receive ifetroban (200 mg dose per day) for 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will be randomized to receive placebo for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- History of AERD, defined as meeting the diagnostic triad with:
- Stable asthma (post-bronchodilator forced expiratory volume at one second (FEV1) of ≥70%, no glucocorticoid burst for at least 2 weeks prior to Visit 1, and no hospitalizations or ER visits for asthma for at least the prior 6 months)
- Age between 18 and 70 years
- No current smoking (not more than one instance of smoking in the last 3 months)
- Non-pregnant
Key exclusion criteria (6 listed)
- Hypersensitivity to montelukast
- Current use of zileuton
- History of bleeding diathesis or use of anticoagulant or antiplatelet drugs
- Current use of any NSAIDs aside from the aspirin provided during the study
- Current use of beta blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IfetrobanAlso: ifetroban sodium4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD | Drug | Ifetroban |
| Placebo4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD | Drug | Placebo |
Primary outcome
Provocative Dose 2 (PD2) During Aspirin Challenge
Time frame: 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
6 secondary outcomes
Percentage Change From Baseline of FEV1 During Aspirin Challenge (Bronchoconstriction)
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
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
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
Time frame: 1 month (between Visit 1 and Visit 2)
Clinical Improvement of Chronic Disease - Sino-Nasal Outcome Test (SNOT-22) Score
Time frame: 1 month (between Visit 1 and Visit 2)
Fractional Exhaled Nitric Oxide (FeNO)
Time frame: 1 month (between Visit 1 and Visit 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliot Israel, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ifetroban in people with Nasal Polyps and Asthma, Aspirin-Induced, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provocative Dose 2 (PD2) During Aspirin Challenge (time frame: 6 weeks from screening visit ( at visit 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.