The efficacy of tiotropium administered via Respimat® Soft Mist™ Inhaler or HandiHaler® in COPD patients - 08/08/11
, P.J.G. Cornelissen b, J.-L. Aumann c, J. Platz b, A. Mueller b, C. Fogarty d
Corresponding author. Department of Respiratory Diseases, Atrium Medisch Centrum, Henri Dunantstraat 5, 6419 PC Heerlen, The Netherlands. Tel.: +31 45 5766104; fax: +31 45 5767534.Summary |
Background |
Tiotropium, a once daily inhaled anticholinergic delivered via HandiHaler®, provides bronchodilation for >24h and improves patient-centred outcomes. The Respimat® Soft Mist™ Inhaler (SMI), a novel, propellant-free inhaler, has been developed and proposed as an alternative delivery device for use with tiotropium.
Methods |
In a pre-specified, pooled analysis of two 30-week, double-blind, double-dummy, crossover studies, 207 patients with Chronic Obstructive Pulmonary Disease (COPD) were randomised to receive once daily tiotropium 5μg or 10μg (aqueous solution delivered via Respimat SMI), tiotropium 18μg (inhalation powder via HandiHaler) or placebo. The primary endpoint was trough forced expiratory volume in 1s (FEV1) response. Forced vital capacity (FVC), peak expiratory flow rate (PEFR), rescue medication use, safety and pharmacokinetics (in a subgroup of patients) were also assessed.
Results |
Both tiotropium doses delivered by Respimat SMI were significantly superior to placebo and non-inferior to tiotropium 18μg HandiHaler on the primary endpoint (all p<0.0001). All active treatments were significantly superior to placebo (all p<0.0001) and both doses of tiotropium Respimat SMI were non-inferior to tiotropium 18μg HandiHaler on the secondary spirometry variables and rescue medication use. The systemic exposure was similar between tiotropium 5μg Respimat SMI and tiotropium 18μg HandiHaler but was higher for tiotropium 10μg Respimat SMI. All active treatments were well tolerated.
Conclusions |
Tiotropium 5μg Respimat SMI is comparable with tiotropium 18μg HandiHaler in terms of efficacy, pharmacokinetics and safety. Respimat SMI is an effective alternative, multi-dose delivery device for tiotropium.
Le texte complet de cet article est disponible en PDF.Keywords : Anticholinergics, Bronchodilators, Chronic obstructive pulmonary disease, Inhalation therapy, Respimat®, Tiotropium
Plan
 | Co-ordinating centres of this multicentre study were the Atrium Medisch Centrum, Heerlen and Spartanburg Clinical Research, USA. |
Vol 103 - N° 1
P. 22-29 - janvier 2009 Retour au numéro
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