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OpenTrials
Completed

NCT Number: NCT04287621

Registry of Asthma Patients Initiating DUPIXENT®

The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting to understand the attributes of treated patients in real life.

This includes characterization of:

* Patient demographics (eg, gender, age, and race) * Patient baseline characteristics (eg, prior medications and procedures, medical history, asthma history, weight, height)

The secondary objectives of the study are:

* To characterize real-world use patterns of DUPIXENT® for asthma * To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting * To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT® * To collect long-term 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

St. Paul's Hospital, Vancouver, British Columbia, Canada

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About this study

3-year registry of real-world use of DUPIXENT® for asthma in patients age 12 and over

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Willing and able to comply with the required clinic visits, study procedures and assessments
  • Able to understand and complete study-related questionnaires
  • Provide signed informed consent; for patients under the age of 18, both parental (legal guardian) consent and patient assent are required
  • Initiating treatment with DUPIXENT® for a primary indication of asthma according to the country-specific prescribing information

Key Exclusion Criteria:

  • Patients who have a contraindication to DUPIXENT® according to the country-specific prescribing information
  • Treatment with dupilumab within 6 months before the screening visit, or within 6 months of the baseline visit if the screening and baseline occur on the same day
  • Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study or personal conditions and circumstances that can predictably prevent the patient from adequately completing the schedule of visits and assessments.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Treatment and study plan

Dupixent®

Drug

There is no investigational product provided by the study sponsor and no therapeutic intervention regulated by this protocol. As a condition for eligibility, patients are required to initiate DUPIXENT® for asthma, according to the country-specific prescribing information, prescribed by their physician as part of their normal care (ie, not for the purpose of enrolling in the registry). Once patients enter the study, there are no protocol requirements regarding DUPIXENT® or any other treatments.

Other names: dupilumab, REGN668, SAR231893

Primary outcomes

  1. Demography

    Time frame: At Baseline

    Including gender, age, race

  2. Baseline Characteristics

    Time frame: At Baseline

    Including prior medications and procedures, medical history, asthma history, weight, height

Secondary outcomes

  1. Baseline Treatment Characteristics

    Time frame: At Baseline

    Including but not limited to treatment dose, frequency, duration and asthma treatment associations.

  2. Incidence of adverse events (AEs)

    Time frame: Baseline up to 3 years

    Including but not limited to: frequency, percentage and exposure-adjusted incidence rate of AEs

  3. Physician Assessment: - Spirometry

    Time frame: Baseline up to 3 years

    Assessment collected as per standard of care. Includes forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory flow (FEF) between 25% to 75% of vital capacity (FEF25%-75%), post-bronchodilator FEV1.

  4. Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)

    Time frame: Baseline up to 3 Years

    Assessment collected as per standard of care.

  5. Patient Reported Outcome: Asthma Control Questionnaire, 6-item (ACQ-6)

    Time frame: Baseline up to 3 Years

    Questionnaire assessing the most common asthma symptoms during the previous week, using a 7-point Likert scale (0=fully controlled; 6=severely uncontrolled). Higher score indicates worse asthma control.

  6. Patient Reported Outcome: Mini Asthma Quality of Life Questionnaire (MiniAQLQ)

    Time frame: Baseline up to 3 Years

    Questionnaire answered using a 7-point Likert scale (1=maximum impairment; 7=no impairment). Higher score indicates less impact of asthma on quality of life.

  7. Patient Reported Outcome: Global Patient Assessment

    Time frame: Baseline up to 3 Years

    Assessing patient's symptom severity over the past week and the patient's overall satisfaction with their asthma treatment. Higher scores indicate higher severity of asthma symptoms and lower satisfaction with asthma treatment.

  8. Patient Reported Outcome: Physical Activity Limitation Questionnaire (PALQ)

    Time frame: Baseline up to 3 Years

    Assessing patient's physical activity in their free time. Higher score indicates more health-related quality of life impairment.

  9. Patient Reported Outcome in patients with allergic rhinitis: Allergic Rhinitis Visual Analog Scale (AR-VAS)

    Time frame: Baseline up to 3 Years

    Assessing severity of rhinits symptoms where higher score indicates more bothersome allergic symptoms.

  10. Patient Reported Outcome in patients with allergic rhinitis: Standardized Rhinoconjunctivitis Quality of Life Questionnaire for patients 12 years of age and older (RQLQ[S]+12)

    Time frame: Baseline up to 3 Years

    Health-related quality of life signs and symptoms that are most problematic, as a result of perennial or seasonal allergic rhinitis. RQLQ(S)+12 responses are based on 7-point Likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled). Higher score indicates more health-related quality of life impairment.

  11. Patient Reported Outcome in patients with chronic (rhino) sinusitis and/or nasal polyps: Sino-Nasal Outcome Test (SNOT-22)

    Time frame: Baseline up to 3 Years

    Questionnaire to assess the impact of chronic rhinosinusitis on quality of life. Lower score represents better health related quality of life.

  12. Patient Reported Outcome in patients with atopic dermatitis: Patient Oriented Eczema Measure (POEM)

    Time frame: Baseline up to 3 Years

    Questionnaire assessing eczema severity with lower score representing impact of lower severity of less severe eczema.

  13. Patient Reported Outcome: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-asthma)

    Time frame: Baseline up to 3 Years

    Questionnaire to measure impairments in work and activities with higher score indicating greater impairment and less productivity.

  14. Healthcare Utilization: Healthcare Resource Utilization Questionnaire (HCRUQ)

    Time frame: Baseline up to 3 years

    The HCRUQ collects information on unscheduled healthcare resource encounters related to asthma

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study title

Registry of Asthma Patients Initiating DUPIXENT® (RAPID)

Acronym: RAPID

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2020
Registry last updated
Jun 4, 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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