The efficacy of tiotropium administered via Respimat Soft Mist Inhaler or HandiHaler in COPD patients.
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 5 microg or 10 microg (aqueous solution delivered via Respimat SMI), tiotropium 18 microg (inhalation powder via HandiHaler) or placebo. The primary endpoint was trough forced expiratory volume in 1s (FEV(1)) 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 18 microg 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 18 microg HandiHaler on the secondary spirometry variables and rescue medication use. The systemic exposure was similar between tiotropium 5 microg Respimat SMI and tiotropium 18 microg HandiHaler but was higher for tiotropium 10 microg Respimat SMI. All active treatments were well tolerated.


CONCLUSIONS
Tiotropium 5 microg Respimat SMI is comparable with tiotropium 18 microg HandiHaler in terms of efficacy, pharmacokinetics and safety. Respimat SMI is an effective alternative, multi-dose delivery device for tiotropium.
van Noord
J A
JA
Department of Respiratory Diseases, Atrium Medisch Centrum, Heerlen, The Netherlands. j.a.vannoord@atriummc.nl
Cornelissen
P J G
PJ
Aumann
J-L
JL
Platz
J
J
Mueller
A
A
Fogarty
C
C
D000280:Administration, Inhalation; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D036501:Metered Dose Inhalers; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D012602:Scopolamine Derivatives / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D000069447:Tiotropium Bromide; D016896:Treatment Outcome
D001993:Bronchodilator Agents; D012602:Scopolamine Derivatives; D000069447:Tiotropium Bromide