A randomized, double-blind, placebo controlled study assessing the long-term effect of dupilumab on prevention of lung function decline in patients with uncontrolled moderate to severe asthma (ATLAS)

Conditions

Asthma

Brief summary

Rate of change from week 8 to week 52 on post-BD FEV1 slope in FeNO population

Detailed description

Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population, Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population, Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations, Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations, Annualized severe exacerbation rate during the 52-week period in FeNO and Total populations, Change from baseline to week 52 in fractional exhaled nitric oxide (FeNO) levels in FeNO and Total populations, Change from baseline to week 52 in Asthma Control Questionnaire 7 items (ACQ-7) in FeNO and Total populations, Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations, Change from baseline to week 52 in Forced Vital Capacity (FVC) in FeNO and Total populations, Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population, Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations, Change from baseline to week 104 in post-BD FEV1 in FeNO and Total populations, Annualized severe exacerbation rate during the 104-week period in FeNO and Total populations, Change from baseline to week 104 in FeNO levels in FeNO and Total populations, Change from baseline to week 104 in ACQ-7 in FeNO and Total populations, Change from baseline to week 104 in pre-BD FEV1 % predicted in FeNO and Total populations, Change from baseline to week 104 FVC in FeNO and Total populations, Change from baseline to week 52 in Asthma Quality Of Life Questionnaire with Standardized Activities (AQLQ(S)) in FeNO and Total populations, Change from baseline to week 104 in AQLQ(S) in FeNO and Total populations, Rate of change from week 8 to week 156 on post-BD FEV1 slope in FeNO and Total populations, Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), Incidence of adverse events of special interest (AESIs)

Related papers

No related papers found yet.

Interventions

DRUGDupilumab

DRUGdupilumab placebo

DRUGsolution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rate of change from week 8 to week 52 on post-BD FEV1 slope in FeNO population	—

Secondary

Measure	Time frame
Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population, Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population, Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations, Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations, Annualized severe exacerbation rate during the 52-week period in FeNO and Total populations, Change from baseline to week 52 in fractional exhaled nitric oxide (FeNO) levels in FeNO and Total populations, Change from baseline to week 52 in Asthma Control Questionnaire 7 items (ACQ-7) in FeNO and Total populations, Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations, Change from baseline to week 52 in Forced Vital Capacity (FVC) in FeNO and Total populations, Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population, Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations, Change from	—

Measure

Time frame

Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population, Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population, Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations, Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations, Annualized severe exacerbation rate during the 52-week period in FeNO and Total populations, Change from baseline to week 52 in fractional exhaled nitric oxide (FeNO) levels in FeNO and Total populations, Change from baseline to week 52 in Asthma Control Questionnaire 7 items (ACQ-7) in FeNO and Total populations, Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations, Change from baseline to week 52 in Forced Vital Capacity (FVC) in FeNO and Total populations, Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population, Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations, Change from

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Countries

Belgium, Bulgaria, Greece, Hungary, Ireland, Romania, Slovakia

Outcome results

None listed