Study information for participants: investigating a possible treatment for chronic rhinosinusitis without nasal polyps
Quick Reference:
What is the purpose of this study?
Where is my nearest study site?
What is the purpose of this study?
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.)
Where is my nearest study site?
Here is a list of all of the sites who are currently recruiting for this study:
- Brisbane, QLD
- Sunshine Coast, QLD
- Melbourne, VIC
- Spearwood, WA
Who can participate?
To take part in this study, you will need to meet all the following:
- 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 applicabl
Who cannot participate?
Unfortunately, if any of the following apply to you, this study is not the right fit for you:
- 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.
What is involved?
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.
If you take part in the research study, there will be:
- Reimbursement of costs: For out-of-pocket expenses, such as travel and parking
- Free study-related medical care: You may gain access to new research treatments, before they are widely available.
- No overnight stays: All study visits are day clinic visits and telephone calls only.
Who is involved?
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.
FOR MORE INFORMATION OR TO REGISTER YOUR INTEREST, VISIT trials.evrima.com/chronic-sinusitis-study
This trial has been approved by an independent ethics committee
Ready to register? Click here to register your interest and start your clinical trial journey.
Upon completion of your form, your form responses will determine if you are eligible to proceed to the next stage of the clinical trail being conducted by our study partner Citeline.
Still have questions? Use the form below and one of our patient experience team members will be in touch to assist with your enquiry!