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OpenTrials
Completed

NCT Number: NCT04550962

Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT)

Primary Objective:

The primary objective of the study is to characterize patients initiating DUPIXENT for asthma in a real-world setting, with respect to their medical history, including asthma history and asthma treatment history, socio-demographic, biomarkers (including Fractional exhaled nitric oxide [FeNO]), and concomitant treatments for asthma.

Secondary Objectives:

The secondary objectives of the study are:

* To characterize real-world use patterns of DUPIXENT for asthma (eg, most commonly used regimens, reason for initiation of new asthma treatments, concomitant therapies, treatment durations, and reasons for discontinuation and/or switching) * To assess the effectiveness of DUPIXENT in asthma patients in a real world setting (lung function improvement, exacerbation rate, asthma control) * To assess comorbid type 2 conditions (atopic/allergic) and patterns of use and effects of treatment in comorbid conditions in asthma patients treated with Dupixent * To collect data on HealthCare Resource Utilization (HCRU) * To collect safety data on study participants in the real-world setting.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number : 0320005, La Plata, Buenos Aires, Argentina

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About this study

Each patient will be followed for up to 36 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, 12 years or older
  • Initiating treatment with Dupixent for asthma according to the country-specific prescribing information
  • Willing and able to comply with the required clinic visits, study procedures and assessments.
  • Provided signed informed consent

Exclusion criteria

  • Patients who have a contraindication to Dupixent according to the country-specific prescribing information
  • Treatment with Dupixent within 6 months before the baseline visit. Note: for patients who have been treated previously with DUPIXENT a washout period of 6 months is required before Visit 1.
  • Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments
  • Patients currently participating in any interventional clinical trial which modifies patient care.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Dupilumab SAR231893

Drug

Pharmaceutical form:solution Route of administration: subcutaneous

Dose regimen:

Other names: Dupixent

Primary outcomes

  1. Baseline Characteristics: Socio-demographics

    Time frame: At baseline

    Socio-demographics including but not limited to gender, age, race, weight, and height

  2. Baseline Characteristics: Medical history

    Time frame: At baseline

    Including asthma history and asthma treatment history

  3. Baseline Characteristics: Disease characteristics

    Time frame: At baseline

    Disease characteristics including asthma, comorbid conditions, family history and history of inflammatory diseases

  4. Baseline Characteristics: Biomarkers

    Time frame: At baseline

    Including fractional exhaled nitric oxide (FeNo), blood eosinophils count, immunoglobulin E (IgE total/specific)

  5. Baseline Characteristics: Concomitant treatments for asthma

    Time frame: At baseline

Secondary outcomes

  1. Dupixent and other asthma treatment use patterns

    Time frame: Baseline to Month 36

    Including doses and dose frequency, treatment duration, asthma treatment associations (eg, Dupixent monotherapy, Dupixent + inhaled corticosteroids (ICS), Dupixent + ICS + additional controllers, oral corticosteroid (OCS) burst), and reasons for initiation and for discontinuation/switching.

  2. Lung function

    Time frame: Baseline to Month 36

    Pre and post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) over time.

  3. Annualized exacerbation rate

    Time frame: Baseline to Month 36

    A severe exacerbation event is defined as a deterioration of asthma requiring:

    • Use of systemic corticosteroids for ≥3 days; or
    • Hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.

  4. Patient reported outcomes: Asthma Control Questionnaire (6-item) (ACQ-6)

    Time frame: Baseline to Month 36

    To evaluate asthma control

  5. Patient reported outcomes: Patient Oriented Eczema Measure (POEM) among participants with atopic dermatitis

    Time frame: Baseline to Month 36

    Among participants with atopic dermatitis

  6. Patient reported outcomes: Allergic Rhinitis Visual Analogue Scale (AR-VAS) among participants with allergic rhinitis

    Time frame: Baseline to Month 36

    Among participants with allergic rhinitis

  7. Patient reported outcomes: Sino-nasal Outcome Test (SNOT-22)

    Time frame: Baseline to Month 36

    Among participants with chronic rhinosinusitis with nasal polyps [CRSwNP] and chronic rhinosinusitis [CRS] without nasal polyps [NP])

  8. Healthcare Resource Utilization

    Time frame: Baseline to Month 36

    The Healthcare Resource Utilization (HCRU) collects information on unscheduled healthcare resource encounters including inpatient visits, emergency room visits, physician office visits related to asthma, including the dates of visits and duration of any hospitalizations, together with the reason for the visits

  9. Number of participants with adverse events (AE) and serious adverse events (SAE)

    Time frame: Baseline to Month 36

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

PRospEctiVe charactErization of Asthma Patients Treated With DupilumAb in reaL World Setting

Acronym: REVEAL

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2020
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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