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Tiotropium Respimat effective, safe as add-on therapy for pediatric asthma

The use of tiotropium Respimat as an add-on treatment to medium dose-inhaled corticosteroids improved lung function in children with symptomatic asthma and did not show an increase in adverse events, according to study results.

Researchers in Germany, Lithuania and the United States conducted a phase 2, double blind, placebo-controlled, incomplete-crossover dose-ranging study on children, aged 6 to 11 years, in six countries from August 2011 to September 2012. They sought to determine the efficacy of tiotropium Respimat (tiotropium bromide inhalation spray, Boehringer Ingelheim) as an additional treatment to inhaled corticosteroids.

The researchers randomly assigned participants to receive once-daily tiotropium Respimat 5 µg (n = 76), 2.5 µg (n = 74), and 1.25 µg (n = 75) or placebo (n = 76) during a 12-week period.

Peak forced expiratory volume in 1 second (FEV₁) response after 4 weeks of treatment increased significantly at each dose of tiotropium Respimat when compared with placebo. The highest peak FEV₁ was seen in tiotropium Respimat 2.5 µg, an increase of 104 mL (P < .0001).

An adjusted mean trough was observed in each tiotropium Respimat dose group when compared with placebo. The biggest difference was observed in dosages of 2.5 µg (105 mL, P < .0001) and 5 µg (98 mL, P < .0001).

Adverse events were comparable between all tiotropium and placebo groups. There were no deaths, nor adverse events that led to study discontinuation.

The researchers acknowledged that the study was limited by its design and duration.

“The short duration of the study meant that the focus was on assessment of lung function, and did not allow for a full assessment of asthma symptom control or exacerbation rate,” the investigators concluded. – by Ryan McDonald

Disclosure: Vogelberg reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.