Introduction and objectives A Phase II trial has shown that tiotropium Respimat® (tioR) is an effective, safe, and well-tolerated bronchodilator in patients aged 6–11 years with moderate symptomatic asthma.1 To further assess the efficacy and safety of once-daily tioR add-on therapy, a Phase III trial was carried out in patients aged 6–11 years with moderate symptomatic asthma.
Methods This 48-week, Phase III, randomised, double-blind, placebo-controlled, parallel-group study (CanoTinA-asthma®; NCT01634139) was performed in patients aged 6–11 years with moderate symptomatic asthma. Patients received once-daily tioR 5μg (2 puffs, 2.5 µg), tioR 2.5 μg (2 puffs, 1.25 µg) or placebo Respimat® (pboR; 2 puffs) as add-on to maintenance treatment of at least medium-dose inhaled corticosteroid (ICS) (200–400 µg budesonide or equivalent) alone or in combination with another controller medication. The primary end point was peak FEV1 within 3 hours post-dosing (FEV1(0–3 h)). Secondary end points included trough FEV1 (key end point), FEV1 area under the curve (AUC) (0–3 h), and peak FVC (0–3 h); all measured as response (change from baseline) at Week 24. Adverse events (AEs) were analysed descriptively.
Results Of 403 patients randomised, 401 were treated. Baseline demographics and disease characteristics were balanced between treatment groups. TioR 5 µg and 2.5 µg provided statistically significant improvements in lung function versus pboR at Week 24 (Table) with adjusted mean difference ± standard error peak FEV1 (0–3 h) improvements of 164 ± 31 ml (p < 0.0001) and 170 ± 31 ml (p < 0.0001), respectively. The frequency of patients with AEs was similar across treatment arms, with a low incidence of drug-related and serious AEs (Table); no deaths occurred. The most common AEs were asthma worsening/exacerbation (lower incidence in tioR 5µg and 2.5 µg [34.1% and 36.3%] vs pboR [43.5%]), decreased peak expiratory flow rate (21.5% and 23% vs 20.6%), nasopharyngitis (8.9% and 11.1% vs 9.9%) and respiratory tract infection (9.6% and 8.1% vs 12.2%).
Conclusion In patients aged 6–11 years with moderate symptomatic asthma, once-daily tioR add-on to ICS with or without other maintenance therapy significantly improves lung function compared with pboR. The safety profile of tioR was similar to that of pboR.
Vogelberg C, et al. Respir Res 2015;16(1):20.
ReferencePlease refer to page A272 for declarations of interest in relation to abstract P156.
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