GlaxoSmithKline Initiates Phase II Trial for COPD Treatment
Posted on: Thursday, 1 November 2007, 15:00 CDT
GlaxoSmithKline has initiated a Phase II clinical study of an investigational compound for the treatment of chronic obstructive pulmonary disease.
The Phase II double-blind, randomized study is designed to evaluate the safety and efficacy of GSK961081 doses administered once daily for 14 days in a dry powder inhaler. Approximately 40 patients will be randomized to receive the drug dosed once-daily; salmeterol dosed twice-daily plus tiotropium dosed once-daily; or placebo, in this crossover design study.
The goal of this program is to develop a once-a-day medicine with improved efficacy relative to existing therapies of inhaled beta2-adrenoceptor agonists and anti-muscarinic drugs used for the treatment of chronic obstructive pulmonary disease (COPD).
The bifunctional muscarinic antagonist-beta2 agonist compound was discovered by Theravance and is being developed by GlaxoSmithKline under an agreement between the companies.
Michael Kitt, senior vice president of development at Theravance, said: "By combining the activities of the two approaches to COPD treatment, along with high lung selectivity, in one MABA compound, we aim to develop a medicine with greater efficacy than single mechanism bronchodilators, such as tiotropium or salmeterol, and with equal or better tolerability."
Source: Datamonitor
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