Have you been living with chronic sinusitis without nasal polyps for at least 12 weeks?

Trial ID: NCT06013241
You may be eligible to participate in a study that is evaluating a possible treatment for chronic rhinosinusitis without nasal polyps (CRSsNP)

About the Trial:

Qualified participants will be enrolled in the study for about 33 weeks (which includes a screening and a follow up period) and visit a study site approximately every 4 weeks. The study sponsor may cover travel expenses related to the study visits for the participant in applicable countries only.

Estimated Enrollment

270 Participants

Phase

2b

Can I Participate?

Participants must:

Inclusion Criteria

Participants must

  • Be available for the entire study.
  • Be between 18 and 75 years of age (both inclusive).
  • Have had previous nasal surgery for chronic rhinosinusitis and/or treatment with steroid medications or antibiotics for chronic rhinosinusitis within the last year.
  • Agree to use contraceptives as instructed by the study doctor, if applicable.

Participants must not:

Exclusion Criteria

Participants must not

  • Have chronic rhinosinusitis with nasal polyps.
  • Be scheduled for sinus surgery at any time during the study or had recent nasal surgery.
  • Have acute rhinosinusitis (temporary infection of nose or sinuses that often happens after a cold).
  • Have seasonal allergies whose symptoms are expected to occur during the study.
  • Have gum disease that is currently being treated or expected to be treated during the study.
  • Have any other illness or abnormal test results that the study doctor believes would affect your participation in the study or your safety.
  • Require treatment with medications or therapies that are not allowed during the study.

See if You are Eligible

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About the Study

Insmed Incorporated (the study sponsor) is evaluating the safety and efficacy of the study drug brensocatib in patients with chronic rhinosinusitis without nasal polyps. This study will include adults between the ages of 18 and 75 from around the world with ongoing runny and stuffy nose, facial pain, and a decreased sense of smell. The aim of this study is to see if an investigational product is effective in improving symptoms due to chronic rhinosinusitis without nasal polyps. Currently, there are no approved therapies for chronic rhinosinusitis without nasal polyps. Participants who qualify for the study will be randomly assigned to receive either brensocatib or a placebo (something that looks like the real medicine but does not contain any of the active ingredients of the medicine.)

What Will Happen in This Study

If you are interested in joining this study and prequalify, you will need to visit a clinical study site. A doctor will explain the study to you. If you agree to join, by reviewing and signing the Informed Consent Form (ICF), the doctors and study staff will perform an evaluation and ask you questions about your medical history to make sure you are eligible to take part in the study.

If eligible and you decide to join the study, you will be seen by a doctor and be randomly assigned into a treatment group, either receiving the study drug or a placebo pill. The medication should be taken once a day for 24 weeks, along with a nasal spray.

Your participation in the trial will last about 33 weeks (which includes a screening and a follow up period) and will include regular study visits, which will occur approximately every 4 weeks.

Full details about the study, visits, and examinations will be discussed with you before you decide to participate in the study.

What can you do next?

  1. Complete the prescreen questionnaire on this website
  2. Select a study site
  3. Share contact information with the study site coordinator
  4. Make contact and respond to the study site coordinator that you selected
  5. Share the NCT Identifier Number with your doctor: NCT06013241

Travel Support

Insmed Incorporated, the study sponsor, may cover travel expenses related to your study visits in applicable countries and only if applicable. Examples of expenses include:

  • bus icon Bus
  • train icon Train
  • car icon Personal vehicle reimbursement

This may be provided in the form of a stipend.

Additional information on travel support may be provided by the site staff should they decide to participate.

Where You Can Join

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Location
Pharmaceutical Research & Consulting Inc - CRN - PPDS
Status
Recruiting
Location
Instituto Médico de la Fundación Estudios Clínicos
Status
Recruiting
Location
St Paul's Hospital
Status
Not yet Recruiting
Location
University of Missouri
Status
Not yet Recruiting
Location
Allergy, Asthma, and Immunology Associates of Tampa Bay
Status
Recruiting
Location
Clinique Spécialisée en Allergie de la Capitale
Status
Recruiting
Location
Mount Sinai Hospital - Canada
Status
Not yet Recruiting
Location
Servicio de Investigacion de Patologias Alergicas-Instituto ABC
Status
Recruiting
Location
Penn State Hershey Medical Group
Status
Not yet Recruiting
Location
Centro de Especialidades Médicas Lobos
Status
Recruiting
Location
Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc. - SacENT
Status
Recruiting
Location
Hopital du Saint-Sacrement
Status
Not yet Recruiting
Location
McGill University Health Center
Status
Not yet Recruiting
Location
The Clinical Research Center LLC - CRN - PPDS
Status
Recruiting
Location
Saint Joseph's Health Care London
Status
Not yet Recruiting
Location
The Asthma and Allergy Center PC
Status
Not yet Recruiting
Location
Charleston ENT and Allergy North Charleston
Status
Recruiting
Location
Vitae Research Center
Status
Not yet Recruiting
Location
Johns Hopkins University
Status
Not yet Recruiting
Location
Memorial Hermann Medical Plaza
Status
Not yet Recruiting
Location
Rush University Medical Center -1725 W Harrison St
Status
Not yet Recruiting
Location
Colorado ENT & Allergy
Status
Not yet Recruiting
Location
Advanced ENT and Allergy
Status
Recruiting
Location
Essential Medical Research
Status
Recruiting
Location
Alfa Medical Research
Status
Not yet Recruiting
Location
Eastern Virginia Medical School
Status
Recruiting
Location
Empire Clinical Research-1060 E Foothill Blvd
Status
Not yet Recruiting
Location
Ear, Nose and Throat Associates of South Florida
Status
Recruiting
Location
Vital Prospects Clinical Research Institute, P.C.
Status
Recruiting
Location
Instituto de Especialidades de la Salud Rosario - Clínica del Tórax
Status
Recruiting
Location
Instituto de Investigaciones En Alergia Y Enfermedades Respiratorias
Status
Recruiting
Location
Centro de Investigaciones Médicas Tucumán
Status
Recruiting
Location
Alamo ENT Associates
Status
Recruiting
Location
Instituto Del Buen Aire
Status
Recruiting
Location
HDH Research, Inc.
Status
Recruiting

See if You are Eligible

Check Eligibility

We'll check to see if you are eligible by asking you some questions.

Share this Trial with a Family Member or Doctor

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Frequently Asked Questions (FAQs)