Spiriva Respimat, previously indicated only in adults, can be used in patients aged 6 years and older with asthma who have experienced one or more exacerbations in the preceding year.
Professor David Halpin, Consultant Physician at the Royal Devon and Exeter Hospital, said: "Asthma is one of the most common long-term illnesses in childhood and yet there are relatively few treatments which have been proven to be of benefit in young patients. I welcome this expanded indication for Spiriva Respimat, which is based upon robust clinical trial evidence, and which recognises the efficacy and safety of tiotropium maintenance therapy in patients as young as 6 years old as well as adults."
Clinical study in children
The efficacy and safety of once-daily tiotropium as add-on therapy in children aged six to 11 years with severe symptomatic asthma were assessed in the 12-week VivaTinA study (n=401). Patients were randomised to receive once-daily tiotropium 5 microgram or 2.5 microgram, or placebo, administered through the Respimat device as add-on to background therapy (high-dose inhaled corticosteroid with ≥1 controller medications or medium-dose inhaled corticosteroid with ≥2 controller medications).
At 12 weeks the peak FEV1 within three hours after dosing (primary endpoint) was significantly improved in the tiotropium 5 microgram group compared with placebo (adjusted mean difference: 139ml [95% CI, 75—203]; p<0.001). The observed improvement in the tiotropium 2.5 microgram group was not significant (adjusted mean difference: 35ml [95% CI, -28 to 99]; p=0.27). Improvements in trough FEV1 response versus placebo after 12 weeks of treatment were also significant for the tiotropium 5 microgram dose (adjusted mean difference: 87ml [95% CI, 19—154], p=0.01) but not for the 2.5 microgram dose (adjusted mean difference: 18ml [95% CI, -48 to 85], p=0.59)
The PensieTinA study involved 392 adolescents aged 12 to 17 years with severe symptomatic asthma, who were randomised to receive once-daily tiotropium 5 microgram or 2.5 microgram, or placebo, delivered via the Respimat device as add-on therapy to inhaled corticosteroids plus ≥1 controller medications.
Numerical improvements in peak FEV1 within three hours after dosing were observed for the tiotropium 5 microgram dose (90ml; p=0.104) and significant improvements for the tiotropium 2.5 microgram dose (111ml; p=0.046) compared with placebo. Numerical improvements in trough FEV1 response and asthma control were observed with both tiotropium doses compared with placebo.
Safety and tolerability of tiotropium in clinical trials were similar to those oberved with placebo.