Researchers wanted to see if children with a certain allele benefitted from receiving montelukast instead of long-acting beta-2 agonist/inhaled corticosteroid therapy.
A study presented this week at the European Respiratory Society International Congress hinted that prescribing according to genetics could benefit the quality of life of some children and teenagers with asthma.
The researchers at the virtual meeting said it was the first trial of its kind, which compared personalized asthma therapy with standard therapy.
Investigators sought to compare the benefit of treating patients based on differences in the A allele of rs1042713 (Arg16 amino acid), a genotype associated with poor response to standard long-acting beta-2 agonist (LABA) therapy among pediatric patients with asthma.
They randomized 241 participants aged 12 to 18 years 1:1 to either rs1042713 genotype-personalized therapy (n = 121) or standard therapy (n = 120). Personalized therapy included montelukast, while standard therapy included a LABA plus inhaled corticosteroid (ICS) treatment.
Results showed that personalized treatment resulted in somewhat improved quality of life as measured by the Asthma Quality of Life Questionnaire (AQLQ) compared with standard care, but results (0.16; 95% CI, 0.00-0.31; P = .049) were below the clinical threshold (0.25).
Children with 2 copies of the genotype showed the greatest improvement, with an average 0.42 increase in their AQLQ score (95% CI, 0.02-0.81; P = .041).
“The potential role of rs1042713 genotype-directed therapy in younger and more severe children’s asthma requires further exploration,” the authors concluded.
In a statement, one of the lead investigators said the modest effect may be due to the overall well-controlled asthma in the cohort, the participants of whom were recruited from primary care practices. “Larger trials, with a focus on those with poorer asthma control, may help us determine the true benefit for children of prescribing in this way," said Somnath Mukhopadhyay, MD, PhD, of Brighton & Sussex Medical School in England.
In the United States in March of this year, montelukast received a black box warning from the FDA to make sure health care providers are aware of the risk of severe mental health adverse effects, including thoughts of suicide, associated with the allergy and asthma drug.
Ruffles T, Jones C, Palmer C, et al. Effect of controller prescribing according to rs1042713 genotype on asthma related quality of life in young people (PACT): a randomized controlled trial. Presented at: Virtual ERS International Congress 2020; September 7-9, 2020. Abstract 4617.