As part of your treatment, you will receive DUPIXENT. We would like to learn what the experiences of patients are with this medical product and if you notice any changes. The aim of the study is to better understand the characteristics of patients…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms benign (excl mesotheliomas)
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Descriptive summary of symptoms, HRQoL, and change over time
• Descriptive summary of patients and disease characteristics with CRSwNP, and
type 2 comorbidities
Secondary outcome
• Descriptive summaries of DUPIXENT and other CRSwNP treatments used during the
study, including most commonly used treatments, dosage, adherence,
interruption, place, and frequency of administration (home or clinic)
• Reasons for initiation of new CRSwNP treatment(s), concomitant therapies,
treatment durations, and reasons for discontinuation and/or switching
• Global assessment of disease severity and treatment satisfaction (patient and
physician)
• Descriptive summary of adverse events
Background summary
Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a chronic disease of
the airways behind the nostrils and sinuses (cavities in the nose that hold
mucus) that affect patients (loss of smell, facial pain) and worsens quality of
life. Dupixent has been studied in randomized control trials as an extra
treatment to standard of care (nasal steroids) but real world data is needed.
This study will focus on the assessment of the use patterns of DUPIXENT for
CRSwNP with details concerning the most common treatment regimens, dosage,
place and device of administration, and reason for starting or stopping, as
well as switching to other therapies. Finally, this registry study aims to
collect long-term safety and effectiveness data on patients with CRSwNP treated
with DUPIXENT. This data will help the development for a better treatment
against CRSwNP.
Study objective
As part of your treatment, you will receive DUPIXENT. We would like to learn
what the experiences of patients are with this medical product and if you
notice any changes. The aim of the study is to better understand the
characteristics of patients who receive DUPIXENT for CRSwNP and the treatment
patterns used in a real-world setting. The study will also collect data on the
long-term effectiveness and safety of DUPIXENT. DUPIXENT is approved in
multiple countries for specific indications and age ranges to treat patients
with atopic dermatitis, asthma, and/or chronic rhinosinusitis with nasal
polyps. Your study physician can provide more detailed information regarding
approved indications in your country.
You have been prescribed DUPIXENT by your doctor, because it is necessary for
your treatment and not in the context of this investigation. That means that
you can collect the medical product at your own pharmacy and possibly have to
pay the normal personal contribution.
Study design
Assessing long-teRm Outcomes of dupiluMAb (AROMA) is a global, prospective,
observational, multicenter, real world study to characterize the safety and
effectiveness of DUPIXENT by evaluating objective findings and patient-reported
outcomes (PROs) in patients with CRSwNP. It will expand on the data from prior
randomized clinical studies and aims to fill the knowledge gaps noted in the
objectives in a real-world setting.
Study burden and risks
It is an observational questionnaire study without intervention. There is no
risk for the patient.
Old Saw Mill River Road 777
Tarrytown, NY 10591
US
Old Saw Mill River Road 777
Tarrytown, NY 10591
US
Listed location countries
Age
Inclusion criteria
1. Patients >=18 years at initiation
2. All patients who are newly initiated on DUPIXENT for the treatment of CRSwNP
according to the respective prescribing information (Product Label or SmPC)
3. Willing and able to comply with clinic visits and study-related procedures
as per protocol
4. Provide informed consent signed by study patient or legally acceptable
representative
5. Able to understand and complete study-related questionnaires as per protocol
Exclusion criteria
1. Patients who have a contraindication to DUPIXENT according to the country
specific prescribing information
2. Any previous treatment with DUPIXENT for any condition
3. Any condition that, in the opinion of the investigator, may interfere with
the patient*s ability to participate in the study, such as short life
expectancy, substance abuse, severe cognitive impairment, or other medical,
social, or personal conditions and circumstances that can predictably prevent
the patient from adequately completing the schedule of visits and assessments
4. Participation in an ongoing interventional or observational study that
might, in the treating physician*s opinion, influence the assessments for the
current study*
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04959448 |
| CCMO | NL80896.028.22 |