A Phase II study conducted by Boehringer Ingelheim has reported positive results for its once-daily tiotropium (spiriva) delivered via the Respimat Soft Mist Inhaler (SMI) in adolescents with symptomatic, moderate, persistent asthma when added to standard care.
Tiotropium is a long-acting muscarinic antagonist (LAMA) that works by opening narrowed airways by targeting a dominant reversible mechanism - cholinergic bronchoconstriction and helping to keep them open for 24 hours with once-daily dosing.
The four-week randomised double-blind placebo-controlled incomplete cross-over dose-ranging Phase II study included 105 patients aged 12 to 17 years with moderate, persistent asthma taking medium dose inhaled corticosteroids (ICS) with or without long-acting beta-agonist (LABA) or leukotriene receptor antagonists (LTRA).
The study demonstrated that all included dosages of once daily tiotropium (1.25mcg, 2.5mcg, 5mcg) increased lung function parameters tested (peak FEV1(0-3h), FEV1AUC(0-3h) and trough FEV1) compared to placebo.
The results are consistent with the previous Phase II proof of concept studies that demonstrated positive clinical activity of tiotropium in adult patients with asthma.
Consultant in respiratory medicine and honorary professor of medicine at University Hospital of Leicester NHS Trust Ian Pavord said the data showed that treatment with tiotropium via the Respimat SMI might positively impact lung function despite the fact that all study patients were already receiving usual care maintenance treatment as defined by GINA guidelines.
Boehringer Ingelheim medical director Charles de Wet said the positive Phase II trial results in moderate asthma provide the company with further confidence for the Phase III clinical trial programme.
"We designed UniTinA-asthma to evaluate the full potential of tiotropium in this indication and will announce first results later this year," de Wet added.
The comprehensive confirmatory Phase III trial named UniTinA-asthma programme includes a number of clinical trials in adults, adolescents and paediatrics involving over 4,000 patients to evaluate the potential of the long-acting bronchodilator in the treatment of asthma.