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(352) 733-0111

Aroma

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The primary objectives of the study are:

  • To longitudinally characterize the long-term effectiveness of DUPIXENT® through assessment of patient-reported symptoms, Health-Related Quality of Life (HRQoL) related to Chronic rhinosinusitis with nasal polyposis (CRSwNP) and other type 2 comorbidities, and their change over-time.

  • To characterize patients who receive DUPIXENT® for CRSwNP in a real-world setting with respect to their medical history, demographic and disease characteristics, and type 2 comorbidities

The secondary objectives of the study are:

  • To characterize real-world utilization of DUPIXENT® for patients with CRSwNP

  • To collect patient and physician global assessment of disease severity and treatment satisfaction for patients receiving DUPIXENT® for CRSwNP

  • To collect long-term safety data for patients receiving DUPIXENT® for CRSwNP

Details

Full study title Assessing Long-Term Outcomes of Dupixent? Treatment in Patients with Chronic Rhinosinusitis with Nasal Polyposis (Aroma)
Protocol number OCR41509
ClinicalTrials.gov ID NCT04959448

Eligibility

Key Inclusion Criteria:

  • All patients who are newly initiated on DUPIXENT® for the treatment of CRSwNP according to the respective prescribing information (Product Label or SmPC)

  • Willing and able to comply with clinic visits and study-related procedures as per protocol

  • Provide informed consent signed by study patient or legally acceptable representative

  • Able to understand and complete study-related questionnaires as per protocol

Key Exclusion Criteria:

  • Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information

  • Any previous treatment with DUPIXENT® for any condition

  • Any condition that, in the opinion of the investigator, may interfere with the patient's ability to participate in the study per protocol

  • Participation in an ongoing interventional or observational study that might, in the treating physician's opinion, influence the assessments for the current study per protocol

Lead researcher

  • Jeb M Justice, MD
    Ear, Nose and Throat Specialist (Otolaryngologist)
    Jeb M Justice

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.