drugset / Trial / NCT00364273

GSK159802 In Healthy Male Subjects And Asthmatics

NCT00364273

Phase 1 Completed 43 enrolled GlaxoSmithKline
RandomizedSingle-groupTreatment

Summary

GSK159802 is a potent, inhaled, long acting selective beta-2-receptor agonist (LABA), which is being developed for once daily treatment of asthma and COPD as part of a combination product with a once daily inhaled corticosteroid and also as a standalone product for the treatment of COPD. Stimulation of the beta-2-agonist in the lung mainly relaxes bronchial smooth muscle cells which results in bronchodilation. Unwanted systemic side effects related with beta-2-agonist treatment such as tachycardia, tremor, hyperglycemia and hypokalemia are limited by local administration and also tend to show tachyphylaxis. The LABAs that are currently available (e.g., salmeterol, formoterol) require twice-daily administration, given their duration of action. Therefore, there is significant opportunity for a once-daily inhaled medication to improve patient compliance and overall disease management by providing sustained, 24-hour bronchodilation.

Timeline

Start
2005-08-24
Primary completion
2006-07-06
Completion
2006-07-06

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK159802 Unknown 150 ug Inhaled
Subject GSK159802 Unknown 300 ug Inhaled
Subject GSK159802 Unknown 600 ug Inhaled
Subject GSK159802 Unknown 900 ug Inhaled
Subject GSK159802 Unknown 1200 ug Inhaled
Subject Salmeterol Other / unclassified 50 ug Inhaled