Boehringer Ingelheim recently announced new results showing that Spiriva Respimat (tiotropium bromide) improved lung function in asthmatic children ages 6 to 11. Data also suggested the drug is safe in children ages 6 to 17 and the drug’s safety profile is consistent in both younger children and adults.
The findings were presented at the European Respirator Society International Congress (ERS 2016) Sept. 3-7 in London.
Tiotropium is an inhaled long-acting, anticholinergic bronchodilator that works by opening airways and helping to keep them open for a minimum of 24 hours. In the U.S., Spiriva Respimat inhalation spray is approved for the long-term maintenance treatment of asthma in people ages 12 or older. But it’s not approved for sudden asthma symptoms.
“Asthma is the most common chronic childhood disease, but many children still continue to experience asthma symptoms despite taking other maintenance therapies,” Christina Vogelberg, professor at Germany’s University Children’s Hospital Dresden, said in a press release.
“These new results showed significant lung function improvements for children with asthma and importantly confirm that the safety profile of tiotropium Respimat in children aged one year and above is comparable to placebo,” she said.
At ERS 2016, Boehringer Ingelheim presented the results of a series of 18 clinical studies included in the Phase 2 and Phase 3 UniTinA-asthma clinical development program, which were conducted at more than 150 sites worldwide with more than 6,000 patients, 1,800 of whom were children and teens ages 1 to 17.
Included in the clinical development program were the Phase 3 trials CanoTinA-asthma (NCT01634139); VivaTinA-asthma (NCT01634152); RubaTinA-asthma (NCT01257230); and PensieTinA-asthma (NCT01277523). The trials investigated tiotropium Respimat as an add-on therapy for children who were already on inhaled corticosteroids (ICS) or an ICS combination with other therapies.
Results from the Phase 3 CanoTinA-asthma trial showed that adding Spiriva Respimat to maintenance asthma therapy significantly improved lung function in children ages 6 to 11, as measured by forced expiratory volume in one second (FEV1) from 0 to 3 hours post-dosage, compared to a placebo.
In addition, a pooled analysis from the four trials also presented at ERS 2016 showed that adding Spiriva Respimat to maintenance therapy for children ages 6 to 17 had a comparable safety profile to a placebo. The drug was also shown to improve peak expiratory flow (PEF), a common measure of asthma control, in participants with the same age interval.
A third presentation, showing data taken from the NinoTinA-asthma trial only, revealed that the safety profile of Spiriva Respimat as maintenance therapy among children ages 1 to 5 was consistent to that found in older children as well as in adults.
“At Boehringer Ingelheim, we have a strong commitment to scientific research with the goal of improving the care of people living with serious respiratory diseases, such as asthma,” said Dr. William Mezzanotte, vice president and head of respiratory medicine at Boehringer Ingelheim. “Data from these studies build on the body of evidence that we have learned about tiotropium Respimat as an asthma therapy.”