Asthma, Aspirin-InducedPhase 2NCT03028350
Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)
A Phase 2 study testing Ifetroban Oral Capsule in people with Asthma, Aspirin-Induced, run by Cumberland Pharmaceuticals at 16 sites in United States.
Trial summary
The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Aspirin-Induced
- What is being tested?
- Ifetroban Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 16 sitesUnited States
- Study dates
- 17 Jul 2017to 25 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of physician-diagnosed asthma
- History of nasal polyposis
- History of at least two reactions to oral aspirin or other nonselective cyclooxygenase inhibitor with features of lower airway involvement (cough, chest tightness, wheezing, dyspnea), or one reaction that was life-threatening and required hospitalization, or a diagnosis of AERD by a physician-conducted challenge to aspirin in the last five years before starting treatment.
- Stable asthma (post-bronchodilator forced expiratory volume in 1 second (FEV1) of ≥ 60%, no glucocorticoid burst for at least two weeks prior to starting treatment, no hospitalizations or emergency room visits for asthma at least three months prior to starting treatment and not on a dose >1000 µg fluticasone or equivalent daily).
- ≥ 18 years of age
- Exhibit symptomatic AERD within three weeks of starting treatment by demonstrating a score of at least 20 on the Sino-nasal Outcome Test (SNOT) - 22.
Who cannot join
- Current smoking, defined as daily tobacco smoking in the last six months and at least one instance of tobacco smoking in the last three months.
- Current pregnancy or breastfeeding
- Use of oral or systemic steroids (e.g. prednisone or equivalent) > 20 mg daily in the last four weeks before starting treatment.
- Daily use of long-acting antihistamines in the last two weeks before starting treatment.
- Less than 12 months of allergy shots (maintenance dose of allergy shots are allowed if treatment duration exceeds 12 months). Less than 1 month of 5-lipoxygenase inhibitors (e.g. zileuton) and/or leukotriene receptor antagonists (e.g. montelukast).
- Any use of nonsteroidal anti-inflammatory drugs (NSAIDs) or any drug that inhibits the cyclooxygenase enzyme in the last two weeks before starting treatment.
Show all 12Show fewer
- History of bleeding diathesis or use of anticoagulant or antiplatelet drugs in the last two weeks before starting treatment.
- Any immunosuppressive treatment including but not limited to methotrexate, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, and cyclophosphamide in the last two weeks before starting treatment (maintenance dose of allergy shots are allowed if treatment duration exceeds 12 months). Biologics/immunotherapies such as Xolair or Nucala are permitted if duration exceeds three months.
- Endoscopic sinus surgery / polypectomy within the past three months
- Previously treated in a clinical trial with ifetroban within the past three months.
- Previously treated with other investigational drugs within eight weeks or five half-lives, whichever is longer, before screening
- Conditions/concomitant disease which make them unevaluable for the efficacy endpoints
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Emory University School of Medicine, Sinus, Nasal, and Allergy Center
Atlanta, Georgia, 30308
University of Virginia Medical Center
Charlottesville, Virginia, 22908
UT Southwestern Medical Center
Dallas, Texas, 75390-9035
Deaconess Clinic
Evansville, Indiana, 47713
The Research Center
Hialeah, Florida, 33013
Antelope Valley Clinical Trials
Lancaster, California, 93534
Advanced ENT & Allergy
Louisville, Kentucky, 40207
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Kansas City Allergy and Asthma Associates, PA
Overland Park, Kansas, 66210
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Rochester Regional Health
Rochester, New York, 14607
Scripps Clinic - Carmel Valley
San Diego, California, 92130
Stanford University Medical Center
Stanford, California, 94305
Montefiore Medical Center
The Bronx, New York, 10461
Banner University of Arizona Medical Center, Asthma & Airway Disease Research Center
Tucson, Arizona, 85724
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27104
About this study
Official title: A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects With Symptomatic Aspirin Exacerbated Respiratory Disease (AERD)
The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs.
Read the detailed description
This is a randomized, placebo-controlled, double-blind phase 2 trial evaluating approximately 76 subjects with symptomatic AERD on the safety and efficacy of 8 weeks of oral ifetroban treatment. Eligible AERD subjects will be randomized to receive 8 weeks of either oral ifetroban daily or matching placebo followed by a 2-week post-treatment period.
- Conditions
- Asthma, Aspirin-Induced
- Being tested
- Ifetroban Oral Capsule, Placebo Oral Capsule
- Medical subject headings
- Asthma, Aspirin-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ifetroban Oral CapsuleDrug
Also called Ifetroban
Subjects will be treated with oral ifetroban daily for 8 weeks
Placebo Oral CapsuleDrug
Also called Placebo
Subjects will be treated with oral placebo daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ifetroban Oral Capsule | Experimental | Oral ifetroban, 200 mg daily for 8 weeks Receives: Drug: Ifetroban Oral Capsule |
| Placebo Oral Capsule | Placebo comparator | Oral placebo daily for 8 weeks Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Sinonasal Outcome Test-22 Score
Sinonasal Outcome Test-22 (SNOT-22) score is a scale with a minimum score of 0 and a maximum score of 110 based on the presence and severity of symptoms and outcomes of rhinosinusitis. Higher scores indicate worse symptoms and/or outcomes.
Measured: Baseline and 8 weeks
Secondary outcomes (6)
Change From Baseline in Asthma Control Questionnaire -7 Score
The Asthma Control Questionnaire-7 is a scoring system with a minimum score of 0 and a maximum score of 6 based on the severity and frequency of asthma symptoms. Higher scores indicate worse control of asthma symptoms.
Measured: Baseline and 8 weeks
Change From Baseline in Total Nasal Symptom Score (Morning)
The Total Nasal Symptom Score is a scoring system with a minimum score of 0 and maximum score of 15 based on severity of nasal symptoms. Higher scores indicate worse nasal symptoms.
Measured: Baseline and 8 weeks
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Change From Baseline in Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Measured: Baseline and 8 weeks
Change From Baseline in Peak Nasal Inspiratory Flow Rate (PNIFR)
Change From Baseline in Peak Nasal Inspiratory Flow Rate (PNIFR) at 8 weeks
Measured: Baseline and 8 weeks
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at 8 weeks
Measured: Baseline and 8 weeks
Change From Baseline in Total Nasal Symptom Score (Afternoon/Evening)
The Total Nasal Symptom Score is a scale with a minimum score of 0 and maximum score of 15 based on severity of nasal symptoms. Higher scores indicate worse nasal symptoms.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start17 Jul 2017
- Primary completion25 Apr 2023
- Study completion25 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 Asthma, Aspirin-InducedStudies of the same condition, open and under way.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew White, MD, Principal investigator, Scripps Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03028350
- Sponsor's protocol ID
- CPI-IFE-006
- Status last verified
- Jun 2024
- First submitted
- 19 Jan 2017
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects With Symptomatic Aspirin Exacerbated Respiratory Disease (AERD)
- ClinicalTrials.gov ID
- NCT03028350
- Acronym / sponsor ID
- CPI-IFE-006
- Conditions
- Asthma, Aspirin-Induced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Posted 28 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this phase 2 study is to assess the safety and efficacy of oral ifetroban for the treatment of aspirin-exacerbated respiratory disease (AERD). AERD is a disease that involves asthma, recurring nasal polyps, and respiratory reactions to aspirin and other nonsteroidal anti-inflammatory drugs.
Detailed description
This is a randomized, placebo-controlled, double-blind phase 2 trial evaluating approximately 76 subjects with symptomatic AERD on the safety and efficacy of 8 weeks of oral ifetroban treatment. Eligible AERD subjects will be randomized to receive 8 weeks of either oral ifetroban daily or matching placebo followed by a 2-week post-treatment period.
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 Oral Capsule | Experimental | Drug: Ifetroban Oral CapsuleOral ifetroban, 200 mg daily for 8 weeks |
| Placebo Oral Capsule | Placebo comparator | Drug: Placebo Oral CapsuleOral placebo daily for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- History of physician-diagnosed asthma
- History of nasal polyposis
- History of at least two reactions to oral aspirin or other nonselective cyclooxygenase inhibitor with features of lower airway involvement (cough, chest tightness, wheezing, dyspnea), or one reaction that was life-threatening and required hospitalization, or a diagnosis of AERD by a physician-conducted challenge to aspirin in the last five years before starting treatment.
- Stable asthma (post-bronchodilator forced expiratory volume in 1 second (FEV1) of ≥ 60%, no glucocorticoid burst for at least two weeks prior to starting treatment, no hospitalizations or emergency room visits for asthma at least three months prior to starting treatment and not on a dose >1000 µg fluticasone or equivalent daily).
- ≥ 18 years of age
Key exclusion criteria (12 listed)
- Current smoking, defined as daily tobacco smoking in the last six months and at least one instance of tobacco smoking in the last three months.
- Current pregnancy or breastfeeding
- Use of oral or systemic steroids (e.g. prednisone or equivalent) > 20 mg daily in the last four weeks before starting treatment.
- Daily use of long-acting antihistamines in the last two weeks before starting treatment.
- Less than 12 months of allergy shots (maintenance dose of allergy shots are allowed if treatment duration exceeds 12 months). Less than 1 month of 5-lipoxygenase inhibitors (e.g. zileuton) and/or leukotriene receptor antagonists (e.g. montelukast).
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 |
|---|---|---|
| Ifetroban Oral CapsuleAlso: IfetrobanSubjects will be treated with oral ifetroban daily for 8 weeks | Drug | Ifetroban Oral Capsule |
| Placebo Oral CapsuleAlso: PlaceboSubjects will be treated with oral placebo daily for 8 weeks | Drug | Placebo Oral Capsule |
Primary outcome
Change From Baseline in Sinonasal Outcome Test-22 Score
Time frame: Baseline and 8 weeks
Sinonasal Outcome Test-22 (SNOT-22) score is a scale with a minimum score of 0 and a maximum score of 110 based on the presence and severity of symptoms and outcomes of rhinosinusitis. Higher scores indicate worse symptoms and/or outcomes.
6 secondary outcomes
Change From Baseline in Asthma Control Questionnaire -7 Score
Time frame: Baseline and 8 weeks
Change From Baseline in Total Nasal Symptom Score (Morning)
Time frame: Baseline and 8 weeks
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline and 8 weeks
Change From Baseline in Peak Nasal Inspiratory Flow Rate (PNIFR)
Time frame: Baseline and 8 weeks
Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Baseline and 8 weeks
Change From Baseline in Total Nasal Symptom Score (Afternoon/Evening)
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- 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.
Andrew White, MD principal investigator
Scripps Research Institute
16 sites 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 Oral Capsule in people with Asthma, Aspirin-Induced, run by Cumberland Pharmaceuticals at 16 sites 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 6 inclusion and 12 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 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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 28 Jun 2024). 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?
Change From Baseline in Sinonasal Outcome Test-22 Score (time frame: Baseline and 8 weeks). 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 10 Jul 2024.