CLINICAL TRIALS
Clinical Trials we offer

Spirair
Treating subjects with implant and delivery device for correction of cartilaginous septal deviation
To qualify for this study, potential study participants must:
- Be 21 years and older

Chronic Rhinosinusitis With Nasal Polyps
The CONTRAST-NP research study is assessingan investigational medicine for Chronic Rhinosinusitis with Nasal Polyps.
To qualify for this study, potential study participants must:
- Be 18 years and older
- Have been diagnosed with Chronic Rhinosinusitis with nasal polyps in both sides of your nose (bilateral)
- Have had treatment in past two years with (or are intolerant of) systemic corticosteroids and/or have had nasal polyp
- surgery
- Have ongoing symptoms such as nasal congestion for at least 8 weeks prior to study screening

Ibuzatrelvir
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With Coronavirus Disease 2019 (COVID-19) Who Are Not Hospitalized But Are at Risk For Severe Disease
- 12 to < 18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
- Presence of risk factors for progression to severe COVID-19 at the time of screening based on age:
- 12 to 49 years of age with at least two risk factors, where one must be moderate immunocompromise;
- 50 to 64 years of age with at least two risk factors;
- 65 to 74 years of age with at least one risk factor;
- For participants 75 years of age or older, there are no requirements related to risk factors.

Lebrikizumab
A study to evaluate the efficacy and safety of lebrikizumab in participants with chronic rhinosinusitis with nasal polyps treated with intranasal corticosteroids
- Adult participants ≥18 years of age at time of signing the informed consent form (ICF) and adolescent participants ≥12 to < 18 years of age and weighing ≥ 40 kg at Visit
- Physician-diagnosed CRS with bilateral NP.
- Prior treatment with SCS for CRS or CRSwNP within the last 2 years (or a medical contraindication or intolerance to SCS), prior surgery for NP, or both.
- Endoscopic bilateral NPS score of at least 5 out of 8, with a minimum score of 2 in each nasal cavity performed at screening (Visit 1) and baseline (Visit 3).
- Ongoing symptoms for at least 8 weeks prior to study entry (screening [Visit 1]), including:
- Nasal congestion with moderate or severe symptom severity (score 2 or 3) at screening (Visit 1) (single day for Visit 1) and a weekly average severity score of at least 1 (range 0 to 3) at randomization (average of the 14 days prior to Visit [baseline]), and
- At least one other symptom, such as, but not limited to, partial loss of smell (hyposmia), total loss of smell (anosmia), or anterior or posterior rhinorrhea.
- Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.

Itepekimab
A 52 week Phase 3 trial to investigate the efficacy, safety, and tolerability of itepekimab in adult participants with inadequatelycontrolled chronic rhinosinusitis with nasal polyps
- Participants must be 18 years of age or older, at the time of signing the informed consent.
- Participants with a history of CRSwNP for at least 1 year prior to screening.
- Participants must have at least one of the following features:
- Prior sinonasal surgery for NP.
- Worsening symptoms of CRS requiring treatment with SCS within the prior 2 years before screening (Visit 1).
- Worsening symptoms of CRS in the past 2 years which would have required treatment with SCS, however participant is intolerant or has a contraindication to SCS.
- An endoscopic bilateral NPS of at least 5 out of maximum score of 8 (with a minimum score of 2 in each nasal cavity) at screening and randomization.
- Ongoing symptoms (for at least 12 weeks before Visit 1) of:
- Nasal congestion/blockade/obstruction with moderate or severe (symptom severity score 2 or 3) at Visit 1 and a weekly average severity of greater than 1 in the week before randomization (Visit 2),
- At least one of the following two symptoms: loss of smell or rhinorrhea (anterior/posterior).score of 2 in each nasal cavity) at screening and randomization.

VivAer
Do you suffer from chronic nasal obstruction
- Are 22 years of age or older
- Experience severe nasal airway obstruction
- Plan to undergo the VivAer procedure to help improve your nasal breathing
Why be part of a Clinical Trial at Breathe Clear Institute?
Our mission is to bring clinical research to as many lives as possible while delivering compassionate, respectful and exceptional care. We are dedicated to clinical research because the medical discoveries can improve the health of current and future generations. We want to serve our community by offering new and innovative treatment options and diagnostic techniques.
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What is a Clinical Trial and what are the benefits?
A clinical trial is a type of research study that helps determine how effective new medications, treatments, and devices are for patients. The information from the study adds to medical knowledge, indicating what is safe and will work to help treat different diseases and conditions. Conducting a clinical trial allows us to comprehend the risks and benefits that may result from the study. Participating in a clinical trial has many potential benefits including access to innovative treatments that are not available outside of the trial setting and experiencing in-depth and attentive care from some of the best health professionals.