| Tiotropium 5microg via Respimat and 18microg via HandiHaler; efficacy and safety in Japanese COPD patients. | |
| | |
MedLine Citation:
|
PMID: 19969446 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
BACKGROUND AND OBJECTIVES: To compare the efficacy and safety of tiotropium inhaled via Respimat Soft Mist Inhaler, a multidose propellant-free inhaler and HandiHaler, a single-dose dry powder inhaler, in a phase 2 study of Japanese COPD patients. METHODS: Patients with FEV(1)<or=70% predicted, FEV(1)/FVC<or=70% and a smoking history of >10 pack-years received tiotropium once daily via Respimat (5microg) and HandiHaler (18microg) for 4 weeks each in a randomised, double-blind, double-dummy, two-way crossover study. Lung function, adverse events, pharmacokinetics and safety were assessed. RESULTS: Of 184 patients screened, 134 were evaluable. The trough FEV(1) response on Day 29 showed Respimat to be non-inferior to HandiHaler (mean treatment difference, 0.008L; 95% CI, -0.009 to +0.024L; p<0.001). Peak and average FEV(1) and FVC responses on Day 1 and Day 29 were very similar for the two treatments. Tiotropium plasma levels and excretion kinetics showed a similar profile of systemic exposure for the two formulations of tiotropium. Adverse events were reported by similar numbers of patients on each treatment, i.e. 27.9 and 30.6% in the Respimat and HandiHaler groups, respectively. CONCLUSIONS: In Japanese patients with COPD, tiotropium Respimat 5microg and tiotropium HandiHaler 18microg showed a similar profile of efficacy, safety and pharmacokinetics. |
| | |
Authors:
|
M Ichinose; T Fujimoto; Y Fukuchi |
Related Documents
:
|
12197896 - Treatment of oral pemphigoid with intravenous immunoglobulin as monotherapy. long-term ... 8058076 - Effects of reducing or discontinuing inhaled budesonide in patients with mild asthma. 15083076 - Monoclonal antibody treatment of orbital lymphoma. 7669646 - The treatment of pemphigus vulgaris. experience with 48 patients seen over an 11-year p... 18425796 - Botulinum toxin for recurrent anal fissure following lateral internal sphincterotomy. 8582826 - Women's patterns of activity over 6 months after coronary artery bypass surgery. |
Publication Detail:
|
Type: Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2009-12-06 |
Journal Detail:
|
Title: Respiratory medicine Volume: 104 ISSN: 1532-3064 ISO Abbreviation: Respir Med Publication Date: 2010 Feb |
Date Detail:
|
Created Date: 2010-02-03 Completed Date: 2010-09-22 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 8908438 Medline TA: Respir Med Country: England |
Other Details:
|
Languages: eng Pagination: 228-36 Citation Subset: IM |
Affiliation:
|
Third Department of Internal Medicine, Wakayama Medical University, Kimiidera, Wakayama, Japan. masakazu@wakayama-med.ac.jp |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Administration, Inhalation Adult Aged Aged, 80 and over Bronchodilator Agents / administration & dosage*, adverse effects, pharmacokinetics Cross-Over Studies Double-Blind Method Drug Administration Schedule Female Forced Expiratory Volume Humans Male Metered Dose Inhalers / utilization Middle Aged Pulmonary Disease, Chronic Obstructive / drug therapy*, metabolism, physiopathology Respiratory Function Tests / methods Scopolamine Derivatives / administration & dosage*, adverse effects, pharmacokinetics Treatment Outcome |
| Chemical | |
Reg. No./Substance:
|
0/Bronchodilator Agents; 0/Scopolamine Derivatives; 136310-93-5/tiotropium |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Effect of isoquinoline alkaloids from two Hippeastrum species on in vitro acetylcholinesterase activ...
Next Document: [F(18)]-fluoroethylcholine combined in-line PET-CT scan for detection of lymph-node metastasis in hi...