ATLAS – 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

Purpose of trial

Dupilumab has demonstrated significant reduction in exacerbations and improvement in lung function compared to placebo as an add-on therapy for patients with moderate-to-severe asthma. Dupilumab may have the potential to prevent or slow therate of lung function decline over time in patients with uncontrolled moderate to severe asthma. The aim of this phase III/IV randomized study is to determine whether patients treated with dupilumab demonstrate prevention or slowing of lung function decline over a period of 3- years compared to standard of care therapy. Overall, this study will generate information on lung function in patients with moderate-to-severe asthma.

Eligibility

• Participant must be at least 19 years old
• They must have asthma, diagnosed by a doctor, for ≥12 months
• They must be taking a medium to high dose ICS in combination with a second medication (eg, LABA, LTRA) with a stable dose ≥1 month prior to Visit 1.
• Patients who need a thirdcontroller medication may still be eligible for this study, if they are on a stable dose of the third controller for ≥1 month prior to Visit 1.
• Patients requiring a fourth controller (Montelukast) for another condition will be considered eligible for this study, and should be on a stable dose for ≥1 month prior to Visit 1

Resources

National Library of Medicine trial link