En studie for å observere hvordan ungdomspasienter med alvorlig atopisk dermatitt til tross for mindre omfattende hudlesjoner (eksemområde og alvorlighetsindeksscore < 16) reagerer på Dupilumab-behandling (AD-BEASCUITS)
En prospektiv observasjonsstudie av ungdomspasienter med alvorlig atopisk dermatitt til tross for mindre omfattende hudlesjoner (eksemområde og alvorlighetsindeksscore < 16) som får dupilumab
Hos ungdom behandlet med dupilumab viste kliniske studier signifikant forbedring av tegn og symptomer på atopisk dermatitt (AD), med en god sikkerhetsprofil. I disse kliniske studiene ble bare pasienter med eksemområde og alvorlighetsindeks (EASI) score høyere enn eller lik (≥) 16 registrert, og effektiviteten på sensitive/synlige områder ble ikke spesifikt evaluert. Ytterligere data om effektiviteten av dupilumab hos ungdommer med moderat til mild EASI-score og alvorlig kløe og/eller lokalisert AD er derfor nødvendig for bedre å forstå de potensielle kliniske fordelene med dupilumab i disse populasjonene.
Dette er en italiensk multisenter, 52-ukers observasjonsstudie (ikke-intervensjonell) som vil samle inn data om egenskapene til ungdom (i alderen 12 til 17 år) deltakere som lider av alvorlig AD med EASI-score mindre enn (<) 16, kvalifisert for systemisk dupilumabbehandling i henhold til italienske refusjonskriterier. Den vil studere den virkelige effektiviteten og sikkerheten til dupilumab i denne populasjonen, effekten av dupilumab på kløe (pruritus), søvn, livskvalitet og relaterte utfall, lokalisert AD i sensitive/synlige områder, og på sameksisterende atopiske tilstander hos ungdom. deltakere som får dupilumab for AD. Den vil også dokumentere dupilumabbehandlingstilfredshet og seponering av dupilumab hos studiedeltakerne.
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Studietype
Registrering (Antatt)
Registrering
Kontakter og plasseringer
Studiekontakt
Studiekontakt
- Navn: Trial Transparency email recommended (Toll free for US & Canada)
- Telefonnummer: option 6 800-633-1610
- E-post: contact-us@sanofi.com
Studiesteder
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Bologna, Italia, 40138
- Rekruttering
- Investigational Site Number: 002
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Brescia, Italia, 25123
- Rekruttering
- Investigational Site Number: 006
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Florence, Italia, 50139
- Rekruttering
- Investigational Site Number: 004
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Milan, Italia, 20122
- Rekruttering
- Investigational Site Number: 001
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Naples, Italia, 80131
- Rekruttering
- Investigational Site Number: 010
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Naples, Italia, 80138
- Rekruttering
- Investigational Site Number: 011
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Roma, Italia, 00133
- Rekruttering
- Investigational Site Number: 005
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Roma, Italia, 00168
- Rekruttering
- Investigational Site Number: 009
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Verona, Italia, 37134
- Rekruttering
- Investigational Site Number: 014
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Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inklusjonskriterier:
- Mann eller kvinne, i alderen 12 til 17 år ved baseline-besøket
- Pasienter med AD som har blitt foreskrevet dupilumab i henhold til refusjonskriteriene for Agenzia Italiana del Farmaco (AIFA) og som oppfyller følgende kriterier:
Pasienter med EASI<16 og
- Children's Dermatology Life Quality Index (CDLQI) ≥ 10 eller
- Peak Pruritus Numerical Rating Scale (PP-NRS) ≥ 7 eller
lokalisering i synlige eller sensitive områder (hode/nakke/hender eller kjønnsorganer)
- Pasienter i stand til å forstå og fylle ut studierelaterte spørreskjemaer
- Forutsatt signert informert samtykke eller samtykke fra foreldre/juridisk akseptable representanter og pasientsamtykke der det er aktuelt
Ekskluderingskriterier:
- Tidligere bruk av dupilumab innen 6 måneder før studiestart
- Pasienter som for tiden deltar i en intervensjonell klinisk studie som endrer pasientbehandling
- Enhver tilstand som, etter etterforskerens oppfatning, kan forstyrre pasientens mulighet til å delta i studien (f.eks. rusmisbruk)
Informasjonen ovenfor er ikke ment å inneholde alle hensyn som er relevante for en potensiell deltakelse i en klinisk studie.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Antall grupper / kohorter
Kohorter og intervensjoner
Gruppe / KohortGruppe / Kohort |
Intervensjon / BehandlingIntervensjon / Behandling |
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Pediatric patients with AD
Pediatric participants (6 months to 17 years) who suffer from severe AD with EASI score < 16 for adolescents (age 12-17 years) and < 21 for children (6 months to 11 years), eligible for systemic dupilumab treatment according to Italian reimbursement criteria.
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Denne studien vil ikke gi noen behandling, bare observere behandlingen slik den er foreskrevet i klinisk praksis.
Andre navn:
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Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Children and Adolescents: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score
Tidsramme: Baseline, Weeks 4, 16 and 52
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicating greater severity of AD. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. |
Baseline, Weeks 4, 16 and 52
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Children and Adolescents: Percentage (%) of participants with EASI-50
Tidsramme: Weeks 4, 16, 52
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicating greater severity of AD. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. |
Weeks 4, 16, 52
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Children and Adolescents: Percentage (%) of participants with EASI-75
Tidsramme: Weeks 4, 16, 52
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicating greater severity of AD. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. |
Weeks 4, 16, 52
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Children and Adolescents: Percentage (%) of participants with EASI-90
Tidsramme: Weeks 4, 16, 52
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EASI measures the severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicating greater severity of AD. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. |
Weeks 4, 16, 52
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Children and Adolescents: Change from baseline in Patient Oriented Eczema Measure (POEM) score
Tidsramme: Baseline, Weeks 4, 16, 52
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The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days).
The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease).
Higher scores indicate more severe disease and poor quality of life.
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Baseline, Weeks 4, 16, 52
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Children and Adolescents: Percentage (%) of children (6-11 years) and adolescents with a ≥ 6-point improvement from baseline in POEM score
Tidsramme: Baseline, Weeks 4, 16, 52
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The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days).
The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease).
Higher scores indicate more severe disease and poor quality of life.
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Baseline, Weeks 4, 16, 52
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Children and Adolescents: Percentage of Infants (6 months-5 years) with a ≥ 3-point Improvement From Baseline in POEM score
Tidsramme: Baseline, Weeks 4, 6 and 52
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The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days).
The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease).
Higher scores indicate more severe disease and poor quality of life.
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Baseline, Weeks 4, 6 and 52
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Children and Adolescents: Percentage (%) of participants with adverse events
Tidsramme: Baseline to Week 52
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Baseline to Week 52
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Children only: Mean Absolute Change from Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score
Tidsramme: Baseline, Weeks 4,6 and 52
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The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20). |
Baseline, Weeks 4,6 and 52
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Children only: Percentage Change from Baseline in SCORAD
Tidsramme: Baseline, Weeks 4, 16 and 52
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The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20). |
Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage (%) change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) at 4, 16, 52 weeks
Tidsramme: Baseline, Weeks 4, 16 and 52
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The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
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Baseline, Weeks 4, 16 and 52
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Adolescents: Participant assessment: Percentage (%) of participants with a ≥4-point improvement from baseline in PP-NRS at 4, 16, 52 weeks
Tidsramme: Baseline, Weeks 4, 16 and 52
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The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
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Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage (%) of participants with a PP-NRS score of 0, 1 to 3, and 4 to 6 at 4, 16, 52 weeks (only patients with baseline PP-NRS ≥ 7
Tidsramme: Weeks 4, 16 and 52
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The PP-NRS is a single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD during the past 24 hours, with 0 = no itch and 10 = worst itch imaginable.
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Weeks 4, 16 and 52
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Children: Absolute Change from Baseline in SCORAD itch VAS
Tidsramme: Baseline, Weeks 4, 16 and 52
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The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20). |
Baseline, Weeks 4, 16 and 52
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Children: Percentage of Patients with Mild or no Itch (SCORAD itch VAS < 4)
Tidsramme: Baseline, Weeks 4, 16 and 52
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The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20). |
Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage (%) change from baseline in Sleep Disturbance Numerical Rating Scale (SD-NRS) at 4, 16, 52 weeks
Tidsramme: Baseline, Weeks 4, 16 and 52
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The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD, with 0 being "no sleep loss related to the symptoms of atopic dermatitis" and 10 being "I did not sleep at all, due to the symptoms of atopic dermatitis".
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Baseline, Weeks 4, 16 and 52
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Children: Mean Absolute Change from Baseline in SCORAD sleep VAS
Tidsramme: Baseline, Weeks 4, 16, and 52
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The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20). |
Baseline, Weeks 4, 16, and 52
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Children: Percentage Change from Baseline in SCORAD Sleep VAS
Tidsramme: Baseline, Weeks 4, 16 and 52
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The SCORAD is a clinical tool used to assess the extent and severity of eczema. The SCORAD for each individual is A/5 + 7B/2 + C. Total score:0-103 A: Area: to determine extent, the sites affected by eczema are shaded on a drawing of a body. The rule of 9 is used to calculate the affected area (A) as a percentage of the whole body. The score for each area is added up. The total area is 'A', which has a possible maximum of 100 percent (%). B: Intensity: A representative area of eczema is selected. In this area, the intensity of each of the following signs is assessed as none (0), mild (1), moderate (2) or severe (3). The intensity scores are added together to give 'B' (maximum 18). C: Subjective symptoms (itch and sleeplessness) are each scored by the patient or relative using a visual analogue scale where 0 is no itch (or no sleeplessness) and 10 is the worst imaginable itch (or sleeplessness). These scores are added to give 'C' (maximum 20). |
Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage (%) change from baseline in Children's Dermatology Life Quality Index (CDLQI) at 4, 16, 52 weeks
Tidsramme: Baseline, Weeks 4, 16 and 52
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The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life.
The higher the score, the greater the impact is on the quality of life.
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Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage (%) of participants who achieve a ≥6-point reduction from baseline in CDLQI score at 4, 16, 52 weeks
Tidsramme: Baseline, Weeks 4, 16 and 52
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The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life.
The higher the score, the greater the impact is on the quality of life.
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Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage of Participants with cDLQI Score of 0-1
Tidsramme: Weeks 4, 16 and 52
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The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life.
The higher the score, the greater the impact is on the quality of life.
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Weeks 4, 16 and 52
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Adolescents: Percentage (%) of Participants with CDLQI Score of < 6 at 4, 16, 52 weeks (only patients with CDLQI ≥ 10 at baseline)
Tidsramme: Weeks 4, 16 and 52
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The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life.
The higher the score, the greater the impact is on the quality of life.
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Weeks 4, 16 and 52
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Children: Mean Absolute Change from Baseline cDLQI / Infants' Dermatitis Quality of Life Index (iDQoL) (for patients ˂ 4 years of age)
Tidsramme: Weeks 4, 16 and 52
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The iDQoL is a questionnaire completed by parents to assess the impact of atopic dermatitis on the quality of life of infants aged 0-3 years (i.e., up to 3 years 11 months.
The Index is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
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Weeks 4, 16 and 52
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Children: Percentage of Participants who Achieve a ≥ 6-point Reduction from Baseline in cDLQI / iDQoL (for patients ˂ 4 years of age)
Tidsramme: Weeks 4, 16 and 52
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The iDQoL is a questionnaire completed by parents to assess the impact of atopic dermatitis on the quality of life of infants aged 0-3 years (i.e., up to 3 years 11 months.
The Index is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
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Weeks 4, 16 and 52
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Children: Percentage of Participants with cDLQI / iDQoL (for patients ˂ 4 years of age) Score of 0-1
Tidsramme: Weeks 4, 16 and 52
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The iDQoL is a questionnaire completed by parents to assess the impact of atopic dermatitis on the quality of life of infants aged 0-3 years (i.e., up to 3 years 11 months.
The Index is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
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Weeks 4, 16 and 52
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Children: Percentage of Participants with cDLQI / iDQoL (for patients ˂ 4 years of age) score < 6
Tidsramme: Weeks 4, 16 and 52
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The iDQoL is a questionnaire completed by parents to assess the impact of atopic dermatitis on the quality of life of infants aged 0-3 years (i.e., up to 3 years 11 months.
The Index is calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
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Weeks 4, 16 and 52
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Adolescents: Percentage (%) change from baseline in Hospital Anxiety and Depression Scale (HADS) at 4, 16, 52 weeks
Tidsramme: Baseline, Weeks 4, 16 and 52
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The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week.
It is comprised of 7 items assessing anxiety and depression respectively.
A Total score is out of 42 (21 per subscale).
Higher scores indicate greater levels of anxiety and/or depression.
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Baseline, Weeks 4, 16 and 52
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Children: Percentage (%) Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) score
Tidsramme: Baseline, Weeks 4, 16 and 52
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PROMIS® is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children.
The total raw score is translated into a T-score for each participant by means of conversion table.
The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.
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Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage (%) change from baseline Atopic Dermatitis Control Tool (ADCT) score at 4, 16, 52 weeks
Tidsramme: Baseline, Weeks 4, 16 and 52
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ADCT is a six-item patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control.
The score ranges from 0-24 with higher scores indicating worsening disease control.
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Baseline, Weeks 4, 16 and 52
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Adolescents: Participant assessment: Percentage (%) of participants with ADCT < 7 at 4, 16, 52 weeks
Tidsramme: Weeks 4, 16 and 52
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ADCT is a six-item patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control.
The score ranges from 0-24 with higher scores indicating worsening disease control.
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Weeks 4, 16 and 52
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Children and Adolescents: Percentage (%) change from baseline the Dermatitis Family Impact (DFI) questionnaire at 4, 16, 52 weeks
Tidsramme: Baseline, Weeks 4, 16 and 52
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The DFI is a 10-item disease specific questionnaire assessing the impact of having a child with AD on family Quality of Life (QoL).
The DFI questions are scored on a four-point Likert scale ranging from 0 to 3, and the total DFI score ranges from 0 to 30.
The time frame of reference is the past week, and a higher DFI score indicates greater impairment in family QoL as affected by AD.
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Baseline, Weeks 4, 16 and 52
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Children and Adolescents: Percentage (%) of Participants with Physician's Global Assessment (PGA) Face 0 or (/) 1, PGA Feet 0/1, PGA Hands 0/1, PGA Genitals 0/1 and at least a 2-point Improvement from Baseline
Tidsramme: Baseline, Weeks 4, 16 and 52
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The PGA score is a measure used in clinical practice and clinical trials to assess the severity of a particular disease.
The PGA chosen for this study ranges from 0-5 point, and the following categories will be used: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
In this study, the Investigator will be evaluating four PGA scores, including PGA face, PGA feet, PGA hands, and PGA genitalia, in order to assess the severity of the localized lesions in AD patients at baseline and at week 4, 16 and 52.
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Baseline, Weeks 4, 16 and 52
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Adolescents: Percentage (%) of Participants with PGA Genitals 0/1 and at least a 2-point Improvement from Baseline
Tidsramme: Baseline, Weeks 4, 16 and 52
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The PGA score is a measure used in clinical practice and clinical trials to assess the severity of a particular disease.
The PGA chosen for this study ranges from 0-5 point, and the following categories will be used: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
In this study, the Investigator will be evaluating four PGA scores, including PGA face, PGA feet, PGA hands, and PGA genitalia, in order to assess the severity of the localized lesions in AD patients at baseline and at week 4, 16 and 52.
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Baseline, Weeks 4, 16 and 52
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Children and Adolescents: Time to Discontinuation and Reasons for Discontinuation
Tidsramme: Baseline up to Week 52
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Baseline up to Week 52
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Mean Time to First TCS/TCI Discontinuation.
Tidsramme: Baseline up to Week 52
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Baseline up to Week 52
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Children: Percentage of Patients that Discontinue Topical Corticosteroids (TCS) and Topical Calcineurin Inhibitors (TCI)
Tidsramme: Baseline, Weeks 4, 16 and 52
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Baseline, Weeks 4, 16 and 52
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Adolescents: Participant assessment: Mean score of Treatment Satisfaction Questionnaire for Medication (TSQM-9) score at 4, 16, 52 weeks
Tidsramme: Weeks 4, 16 and 52
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The 9-item TSQM (TSQM-9) is a questionnaire to assess treatment satisfaction, with scores ranging between 9 and 59, and lower scores indicating lower satisfaction with treatment.
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Weeks 4, 16 and 52
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Adolescents: Percentage (%) change from baseline in Asthma Control Questionnaire (ACQ-6) at 4, 16, 52 weeks in participants with concomitant asthma
Tidsramme: Baseline, Weeks 4, 16 and 52
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The ACQ-6 is a questionnaire that consists of six questions on a scale from 0 to 6 of symptoms.
The questions are about limitations due to asthma and symptoms in the past week.
A lower score corresponds with better asthma control.
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Baseline, Weeks 4, 16 and 52
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Children: Mean Absolute Change from Baseline in Pediatric Asthma Questionnaire (PAQ)
Tidsramme: Weeks 4, 16 and 52
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The PAQ is a 6-item measure for parents or caregivers of children aged 0-11 years with clinician-diagnosed asthma, or those with recurrent viral-associated wheezing with risk factors for persistent asthma, to assess both symptom control and asthma-specific HRQoL impact.
The PAQ features two items that measure asthma exacerbations which use a recall period of "the past month" while the remaining asthma symptoms (coughing a lot, difficulty breathing, or noisy breathing from the chest) and asthma-specific HRQoL items use "the past week".
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Weeks 4, 16 and 52
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Children: Percentage Change from Baseline in Pediatric Asthma Questionnaire (PAQ)
Tidsramme: Weeks 4, 16 and 52
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The PAQ is a 6-item measure for parents or caregivers of children aged 0-11 years with clinician-diagnosed asthma, or those with recurrent viral-associated wheezing with risk factors for persistent asthma, to assess both symptom control and asthma-specific HRQoL impact.
The PAQ features two items that measure asthma exacerbations which use a recall period of "the past month" while the remaining asthma symptoms (coughing a lot, difficulty breathing, or noisy breathing from the chest) and asthma-specific HRQoL items use "the past week".
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Weeks 4, 16 and 52
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Children and Adolescents: Percentage (%) change from baseline in Total Nasal Symptoms Score (TNSS) at 4, 16, 52 weeks in participants with concomitant chronic rhinitis
Tidsramme: Baseline, Weeks 4, 16 and 52
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The TNSS is the sum of scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea using a four-point scale (0-3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity.
TNSS is calculated by adding the score for each of the symptoms to a total out of 12.
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Baseline, Weeks 4, 16 and 52
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- Studieleder: Clinical Sciences & Operations, Sanofi
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- OBS18015
- U1111-1290-5921 (Registeridentifikator: ICTRP)
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