A Study in Male and Female Adolescent Participants With Severe Uncontrolled Asthma Starting Treatment With Dupilumab Injection (Dupixent®)

Asthma Clinical Trial

— PEDIASTHMA  

Official title:

National, Multicentre, Non-interventional, Prospective and Retrospective Study in Adolescent Patients With Severe Uncontrolled Asthma Starting Treatment With Dupilumab (Dupixent®)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05070663
• Other study ID #: OBS17083
• Secondary ID: U1111-1256-9593
• Status: Recruiting
• Start date: November 4, 2021
• Est. completion date: December 15, 2025

Study information

• Verified date: August 2023
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Primary objective: - Describe the characteristics of enrolled severe asthma patients Secondary objectives: - Assess the control of asthma under dupilumab (Dupixent®) treatment until 1 year - Assess the clinical objectives of the asthma care - Assess comorbidities associated with Type 2 inflammation - Assess safety during the year of treatment

Description:

52 weeks

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 15, 2025
• Est. primary completion date: October 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Adolescents, for whom initiation of dupilumab (Dupixent®) for the severe uncontrolled asthma indication was decided by the investigator before the inclusion in the study
• Adolescents = 12 and < 18 years of age at the time of the initiation of Dupixent® treatment

Exclusion Criteria:

• Adult participants = 18 years of age The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
France	Investigational site France	France

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical history (including history of asthma)	Relevant medical history other than asthma according to the investigator (including documented comorbidities associated with type 2 inflammation). Asthma history includes patient age at the time of diagnosis and family history.	At the start of treatment with Dupixent® (day 1)
Primary	Previous treatments for asthma	Background asthma treatments (doses and international nonproprietary name (INN) of inhaled corticosteroids (ICS), long-acting beta-2 agonist (LABA) and oral corticosteroids (OCS), etc) including cumulative yearly dose of OCS. Use of oral corticosteroids due to exacerbation of asthma (dose, INN). Use of emergency treatments (short-acting beta-2 agonist (SABA)) (number of times per week).	At the start of treatment with Dupixent® (day 1)
Primary	Demographic characteristics	Age and gender.	At the start of treatment with Dupixent® (day 1)
Primary	Disease characteristics	Disease characteristics at the inclusion including severity (Global Initiative for Asthma (GINA) step), number of severe exacerbations during the past year, number of days in intensive care unit (ICU) for severe exacerbation since the diagnosis, forced expiratory volume per second (FEV1), Asthma Control Test (ACT) score.	At the start of treatment with Dupixent® (day 1)
Primary	Concomitant medication	Relevant concomitant medication other than medication for asthma according to the investigator.	At the start of treatment with Dupixent® (day 1)
Secondary	Change from baseline to week 52 in asthma control test (ACT) score at each subsequent visit over the year of treatment	ACT score range: 5-25; higher score indicates better asthma control.	From baseline (day 1) to week 52
Secondary	Change from baseline to week 52 in number of annualized exacerbations and description of exacerbation setting	An exacerbation is defined as deterioration of asthma requiring use of systemic corticosteroids for =3 days; or increase in oral corticosteroids (OCS) dose at =2 times the current dose for =3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.	From baseline (day 1) to week 52
Secondary	Change from baseline to week 52 in Paediatric Asthma Quality of Life Questionnaire (PAQLQ) score	Questionnaire including 23 questions in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered).	From baseline (day 1) to week 52
Secondary	Change from baseline to week 52 in corticosteroid dose	Change in corticosteroid dose.	From baseline (day 1) to week 52
Secondary	Change from baseline to week 52 in pre- bronchodilator forced expiratory volume per second (FEV1)	FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.	From baseline (day 1) to week 52
Secondary	Change from baseline to week 52 in number of food allergic reactions	Following food allergic reactions will be recorded: allergic symptoms and anaphylaxis in real life or during an oral food challenge.	From baseline (day 1) to week 52
Secondary	Change from baseline to week 52 in in visual analogue scale (VAS) score for allergic rhinitis	VAS score range: 0 ('no symptoms') to 100 ('severe symptoms').	From baseline (day 1) to week 52
Secondary	Change from baseline to week 52 in in Score for atopic dermatitis (SCORAD) score for atopic dermatitis	SCORAD is a clinical tool for assessing the severity (i.e., extent, intensity) of atopic dermatitis as objectively as possible with scores ranging from 0-100. The higher the score indicates more severe atopic dermatitis.	From baseline (day 1) to week 52
Secondary	Change from baseline to week 52 in sinonasal symptoms of nasal polyposis of food allergies	Following sinonasal symptoms will be recorded: nasal congestion, loss in smell, posterior nasal discharge, anterior nasal discharge.	From baseline (day 1) to week 52
Secondary	Responder rates at week 52 for ACT (according to the minimal important difference (MID))	A participant is defined as responder if he/she has a change from baseline of 3 points or more at week 52 on the ACT score. ACT score range: 5-25; higher score indicates better asthma control.	At week 52
Secondary	Responder rates at week 52 for PAQLQ (according to the MID))	A participant is defined as responder if he/she has a change from baseline of 0.5 points or more at week 52 on the PAQLQ score. The PAQLQ(S) overall score is calculated by adding points of individual responses to all questions, with the higher scores indicating less impairment that is, a better quality of life. Questionnaire including 23 questions in 3 domains (symptoms, activity limitation, emotional function) and a 7-point scale (7 = not bothered at all; 1 = extremely bothered).	At week 52
Secondary	Reasons for Dupixent® discontinuation	All reasons for treatment discontinuation.	Day 1 to week 52
Secondary	Collection of adverse events	Number of adverse events.	Day 1 to week 52
Secondary	Collection of serious adverse events	Number of serious adverse events.	Day 1 to week 52