NEW YORK (Reuters Health) – A new study provides preliminary evidence that tiotropium, a long-acting anticholinergic drug used for chronic obstructive pulmonary disease (COPD), is safe and effective in preschool-age children with asthma symptoms not well controlled by inhaled corticosteroids.
“Treatment options for the management of persistent asthmatic symptoms in the preschool patient population are scarce and are often associated with safety concerns,” the study team notes in their Lancet Respiratory Medicine report online January 16. “Data on the safety and efficacy of potential asthma medications in very young children (age <=5 years) are scarce, mainly because of the few available assessments of efficacy parameters and no consensus over diagnostic criteria.”
In a 12-week randomized trial, Dr. Elianne Vrijlandt from the University of Groningen, the Netherlands, and colleagues assessed the safety and efficacy of tiotropium (2.5 or 5 micrograms via the Respimat inhaler) or placebo, added to inhaled corticosteroids with or without additional controller medication. The participants were 102 children (ages 1 to 5) with persistent asthma symptoms.
The trial was conducted at 32 hospitals, clinics, and clinical research units in 11 countries in Asia, Europe, and North America.
Tiotropium had a “favorable safety profile, similar to that of placebo,” they report, and reduced the risk of asthma exacerbations compared with placebo. Asthma exacerbations were reported in 10 of 34 (29%) children on placebo, compared with five of 36 (14%) on the lower tiotropium dose and two of 31 (6%) on the higher tiotropium dose.
Tiotropium, however, had no apparent effect on daytime asthma symptom scores. “The changes in adjusted weekly mean combined daytime asthma symptom scores between baseline and week 12 were not significantly different between any of the groups,” the investigators write.
They caution that the number of patients in the study was small, and further research is needed to confirm the potential of tiotropium to lower the risk of asthma exacerbations in young children.
“Our results on asthma exacerbation risk provide an important starting point for future trials, suggesting that tiotropium might be a complementary treatment strategy for managing young children with persistent asthmatic symptoms – a population for whom treatment options are scarce and often associated with safety concerns,” Dr. Vrijlandt and colleagues conclude.
In a linked comment, Dr. Alvaro Cruz from the Program for the Control of Asthma, Federal University of Bahai School of Medicine in Salvador, Brazil, notes that the study team had to “overcome the problem of being unable to perform spirometry in most children, which reduced the certainty of asthma diagnoses and caused an inability to use the usual lung function endpoints to measure efficacy. Furthermore, the clinical and ethical concerns of conducting clinical trials in young children had to be addressed.”
This “ambitious” study brings “much-needed preliminary evidence of the safety and efficacy of a new controller medication to add on to inhaled corticosteroids in young children with uncontrolled asthma,” he writes.
Boehringer Ingelheim, maker of tiotropium Respimat, funded the study and has financial relationships with several of the authors.
SOURCES: http://bit.ly/2n5URZu and http://bit.ly/2Gae0kY
Lancet Respir Med 2018.
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