Clinical trial NCT04550962: Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT)
Official title: PRospEctiVe charactErization of Asthma Patients Treated With DupilumAb in reaL World Setting
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2020-09-16
Enrollment: 375
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with asthma initiating DUPIXENT for their asthma according to the prescribing information in effect in each country.

Brief summary: 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.

Detailed description: Each patient will be followed during 36 months.

Eligibility 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

- Most important exclusion criteria for potential participants 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.

Primary outcomes:
measure: Baseline Characteristics: Socio-demographics
timeFrame: At baseline
measure: Baseline Characteristics: Medical history
timeFrame: At baseline
measure: Baseline Characteristics: Disease characteristics
timeFrame: At baseline
measure: Baseline Characteristics: Concomitant treatments for asthma
timeFrame: At baseline
Secondary outcomes:
measure: Dupixent and other asthma treatment use patterns
timeFrame: Baseline to Month 54
measure: Lung function
timeFrame: Baseline to Month 54
measure: Annualized exacerbation rate
timeFrame: Baseline to Month 54
measure: Patient reported outcomes
timeFrame: Baseline to Month 54
measure: Healthcare Resource Utilization
timeFrame: Baseline to Month 54
measure: Number of participants with adverse events (AE) and serious adverse events (SAE)
timeFrame: Baseline to Month 54
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Investigational Site Number : 0320005
state: Buenos Aires
city: Villa Rosa
country: Argentina
facility: Investigational Site Number : 0320006
state: Buenos Aires
city: Ciudad Autonoma Bs As
country: Argentina
facility: Investigational Site Number : 0320001
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320008
city: San Miguel de Tucuman
country: Argentina
facility: Investigational Site Number : 0320009
city: Santa Fe
country: Argentina
facility: Investigational Site Number : 0320004
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Quillota
country: Chile
facility: Investigational Site Number : 1520002
state: Valparaíso
city: Barranquilla
country: Colombia
facility: Investigational Site Number : 1700009
city: Bogota
country: Colombia
facility: Investigational Site Number : 1700004
city: Bucaramanga
country: Colombia
facility: Investigational Site Number : 1700003
city: Ashdod
country: Israel
facility: Investigational Site Number : 3760008
city: Ashkelon
country: Israel
facility: Investigational Site Number : 3760004
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760005
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760003
city: Kfar Saba
country: Israel
facility: Investigational Site Number : 3760001
city: Rehovot
country: Israel
facility: Investigational Site Number : 3760006
city: Tel Aviv
country: Israel
facility: Investigational Site Number : 3760007
city: Kuwait
country: Kuwait
facility: Investigational Site Number : 4140001
city: Achrafieh
country: Lebanon
facility: Investigational Site Number : 4220003
city: Beirut
country: Lebanon
facility: Investigational Site Number : 4220002
city: Beirut
country: Lebanon
facility: Investigational Site Number : 4220001
city: Durango
country: Mexico
facility: Investigational Site Number : 4840003
city: Doha
country: Qatar
facility: Investigational Site Number : 6340001
city: Chelyabinsk
country: Russian Federation
facility: Investigational Site Number : 6430005
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430007
city: Moscow
country: Russian Federation
facility: Investigational Site Number : 6430004
city: Rostov-on-Don
country: Russian Federation
facility: Investigational Site Number : 6430006
city: Saratov
country: Russian Federation
facility: Investigational Site Number : 6430008
city: Stavropol
country: Russian Federation
facility: Investigational Site Number : 6430002
city: Jeddah
country: Saudi Arabia
facility: Investigational Site Number : 6820005
city: Makkah
country: Saudi Arabia
facility: Investigational Site Number : 6820004
city: Riyadh
country: Saudi Arabia
facility: Investigational Site Number : 6820002
city: Riyadh
country: Saudi Arabia
facility: Investigational Site Number : 6820001
city: Singapore
country: Singapore
facility: Investigational Site Number : 7020002
city: Singapore
country: Singapore
facility: Investigational Site Number : 7020001
city: Abu Dhabi
country: United Arab Emirates
facility: Investigational Site Number : 7840006
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number : 7840007
city: Dubai
country: United Arab Emirates
facility: Investigational Site Number : 7840001
city: Sharjah
country: United Arab Emirates
facility: Investigational Site Number : 7840004
city: Sharjah
country: United Arab Emirates
facility: Investigational Site Number : 7840002
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: