You need to have an account to save this trial. Enter your email to create one or login.

Open your email and follow the link to log in.

Back to search

Your journey

1What's a trial

2Find

3Review

4Get in touch

More info

Your journey

What's a trial

Not sure you're well informed about clinical trials? Learn more about their benefits, risks and other important details.

Find

Enter your details like condition, age, gender and other preferences and we will show you a list of all relevant clinical trials.

Review

Review the summary of the selected clinical trial and all the locations near you in order to see if it's of interest to you.

Get in touch

You've found an interesting trial? We'll need a bit more information about you so we can connect you to the doctor in charge.

You can access this

clinical trial

if you have

Asthma, Aspirin-Induced

and you are

over 18

years old

This is a second phase trial assessing

efficacy and side effects of the new treatment.

Show me locations

The purpose

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.

Provided treatments

Drug: Ifetroban Oral Capsule
Drug: Placebo Oral Capsule

Wondering what is the locations section for?

We will connect you to the doctor responsible for this trial and help you get more information.

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.

Full eligibility criteria for NCT03028350

Ages eligible for Study	18 Years and older
Genders eligible for Study	All
Accepts Healthy Volunteers	No

Inclusion Criteria:

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 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.

Exclusion Criteria:

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.
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

All locations for NCT03028350

18 locations

United States (18)

Banner University of Arizona Medical Center, Asthma & Airway Disease Research Center
Tucson, Arizona, United States, 85724
recruiting
Put me in touch!
Antelope Valley Clinical Trials
Lancaster, California, United States, 93534
active not recruiting
Scripps Clinic - Carmel Valley
San Diego, California, United States, 92130
terminated
Stanford University
Stanford, California, United States, 94305
recruiting
Put me in touch!
The Research Center
Hialeah, Florida, United States, 33013
recruiting
Put me in touch!
Emory
Atlanta, Georgia, United States, 30308
recruiting
Put me in touch!
Deaconess Clinic
Evansville, Indiana, United States, 47713
recruiting
Put me in touch!
Kansas City Allergy and Asthma Associates, PA
Overland Park, Kansas, United States, 66210
recruiting
Put me in touch!
Advanced ENT & Allergy
Louisville, Kentucky, United States, 40207
recruiting
Put me in touch!
Montefiore
Bronx, New York, United States, 10461
active not recruiting
Rochester Regional Health
Rochester, New York, United States, 14607
recruiting
Put me in touch!
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27104
terminated
Clinical Research Trials , LLC
Canton, Ohio, United States, 44718
withdrawn
Bend Memorial Clinic
Bend, Oregon, United States, 97701
withdrawn
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
recruiting
Put me in touch!
Vanderbilt University Medical
Nashville, Tennessee, United States, 37232
recruiting
Put me in touch!
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9035
terminated
University of Virginia
Charlottesville, Virginia, United States, 22908
active not recruiting

All Locations

View full eligibility

Results

Tris trial is registered with FDA with number: NCT03028350. The sponsor of the trial is Cumberland Pharmaceuticals and it is looking for 76 volunteers for the current phase.

Official trial title:
A Phase 2 Multicenter, Double-blind, Randomized, Placebo-Controlled Trial to Evaluate Oral Ifetroban in Subjects With Symptomatic Aspirin Exacerbated Respiratory Disease (AERD)

Your journey

1What's a trial

2Find

3Review

4Get in touch

More info

Your journey

What's a trial

Not sure you're well informed about clinical trials? Learn more about their benefits, risks and other important details.

Find

Enter your details like condition, age, gender and other preferences and we will show you a list of all relevant clinical trials.

Review

Review the summary of the selected clinical trial and all the locations near you in order to see if it's of interest to you.

Trial details

Get in touch

You've found an interesting trial? We'll need a bit more information about you so we can connect you to the doctor in charge.

Hello. We will connect you with the medical team running this clinical trial. Let them know who you are!

My name is

Nice to meet you, !
Enter your email to receive important details about the trial.

My email is

We will automatically create an account for you in our system. This will enable you to track the trials that you are interested in.

Please accept the Terms of Use and Privacy Policy.

I have read and agree to the Terms of Use and Privacy Policy

I consent to the processing of personal data related to my health condition

We need to verify your email.

Please check your email and click on the button in it to continue. Or you can paste the code from your e-mail in the field below.

The code from my email is

Great! In order to identify whether this trial is a right match for you we may need to call you.

My phone number is

My condition is

I am a healthy volunteer

We recommend that you share some of your medical history. This will help doctors and speed up the process.

Proceed

Consult your doctor?

Some people want to consult their doctor before considering participation in a clinical trial. This is absolutely normal as your doctor should know your medical history and should be able to advise you. If you want you can easily share the information for this trial with your doctor by clicking on the button below.

Consult my doctor

Cancel

FindMeCure

Future treatments within your reach

A company backed by

Links

Search
Blog
Contact us
Help
Foundation

Legal

Facebook

Twitter

Youtube

support@findmecure.com