Randomized controlled phase 2 trial of hydroxychloroquine in childhood interstitial lung disease.

ABSTRACT:

Background

No results of controlled trials are available for any of the few treatments offered to children with interstitial lung diseases (chILD). We evaluated hydroxychloroquine (HCQ) in a phase 2, prospective, multicentre, 1:1-randomized, double-blind, placebo-controlled, parallel-group/crossover trial. HCQ (START arm) or placebo were given for 4 weeks. Then all subjects received HCQ for another 4 weeks. In the STOP arm subjects already taking HCQ were randomized to 12 weeks of HCQ or placebo (= withdrawal of HCQ). Then all subjects stopped treatment and were observed for another 12 weeks.

Results

26 subjects were included in the START arm, 9 in the STOP arm, of these four subjects participated in both arms. The primary endpoint, presence or absence of a response to treat

SUBMITTER: Griese M 

PROVIDER: S-EPMC9308121 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature