Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT04550962

CompletedN/A

Sponsor: Sanofi

Conditions: Asthma

Interventions: Dupilumab SAR231893

Countries: Argentina, Chile, Colombia, Israel, Kuwait, Lebanon, Mexico, Qatar

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.

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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.
Locations (41)
  • La Plata, Buenos Aires, Argentina
  • Villa Rosa, Buenos Aires, Argentina
  • Ciudad Autonoma Bs As, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • San Miguel de Tucumán, Argentina
  • Santa Fe, Argentina
  • Santiago, Reg Metropolitana de Santiago, Chile
  • Quillota, Valparaiso, Chile
  • Barranquilla, Colombia
  • Bogotá, Colombia
  • Bucaramanga, Colombia
  • Ashdod, Israel
  • Ashkelon, Israel
  • Jerusalem, Israel
  • Jerusalem, Israel
  • Kfar Saba, Israel
  • Rehovot, Israel
  • Tel Aviv, Israel
  • Kuwait City, Kuwait
  • Beirut, Lebanon
  • Beirut, Lebanon
  • El Achrafiyé, Lebanon
  • Durango, Mexico
  • Doha, Qatar
  • Chelyabinsk, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Rostov-on-Don, Russia
  • Saratov, Russia
  • Stavropol, Russia
  • + 11 more on CT.gov