A three-year clinical trial found that tiotropium, an inhaled asthma medication, is safe for preschool children ages one to five but does not reduce severe asthma attacks better than standard therapy alone, leading researchers to conclude it should not be routinely used in younger children with uncontrolled asthma.
- Tiotropium did not meaningfully reduce severe asthma exacerbations requiring hospitalization or systemic steroids compared to placebo
- The drug was confirmed safe with no new safety concerns; adverse events were similar between tiotropium (397) and placebo (450) groups
- Secondary analysis showed potential benefits including fewer nighttime awakenings, though findings lacked statistical significance
- Researchers concluded tiotropium should not be routinely used in preschoolers, despite FDA approval for children aged six and older
A new paper published in eClinical Medicine, part of The Lancet Discovery Science, shared the mixed results of a prescription inhaled medicine that relaxes muscles in the lungs and opens the airways to ease breathing. The study evaluated the drug tiotropium and its benefits to preschool-aged children with severe asthma when added to standard therapy. Its findings are detailed in the paper, “Efficacy and Safety of Tiotropium in Partial and Uncontrolled Preschool Asthma (TIPP): A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.”
Researchers conducting the phase 3 TIPP trial evaluated the drug’s effectiveness in 100 children ages one to five with partially controlled or uncontrolled asthma over a three-year period. The study followed participants for one year across 13 medical centers in Germany. Although tiotropium did not meaningfully reduce the risk of severe asthma attacks in preschoolers when added to standard inhaled corticosteroid therapy, its researchers reported it safe for long-term use in that population.
According to the study, investigators measured the time until participants experienced their first severe asthma exacerbation that required hospitalization or systemic steroid treatment. Children who received tiotropium experienced no greater benefit in reducing the attack than those who were given a placebo.
Nearly all participants experienced some adverse events during the study period, the study’s authors noted, but these were largely reflected in common childhood illnesses and asthma-related complications. Researchers found no new safety concerns associated with tiotropium use. A total of 397 adverse events were reported in the tiotropium group compared to 450 in the placebo group.
Investigators did report some potential benefits of tiotropium use that were revealed in their secondary analysis. These included fewer nighttime awakenings in children receiving tiotropium. Lung function assessments in a small subgroup of older preschoolers also showed numerical improvements, they said, although these findings did not reach statistical significance and require further research.
Researchers acknowledged early recruitment barriers, including ongoing debates over asthma diagnosis in young children, the COVID-19 pandemic and competing respiratory infections such as RSV and influenza. These obstacles reduced enrollment to a smaller number of participants, they said.
Tiotropium is already FDA-approved as an add-on asthma treatment for children aged six years and older. However, the study’s authors concluded that this trial does not support its routine use in younger preschool children with uncontrolled asthma.
