A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The compound GW642444 has previously been found to be well tolerated with no significant side effects in subjects with asthma and healthy volunteers. This study will assess the safety and tolerability of GW642444 in subjects with COPD in order to obtain information to support dosing in a broader population of subjects with COPD
Full description
A multicentre, randomised, placebo-controlled, double-blind, 4-arm parallel-group, 2-week study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of GW642444H (100 administered once daily in the morning via DISKUS™ dry-powder inhaler) compared with SEREVENT (salmeterol) (50mcg administered twice daily via DISKUS dry-powder inhaler) and placebo in subjects with moderate COPD.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- females must be of non-childbearing potential
- moderately severe COPD
Exclusion criteria
- Subjects with a main diagnosis of asthma
- subjects with poorly controlled COPD
- subjects with significant heart, renal, endocrine, psychiatric, immunological or neurological disease.
Trial design
Primary purpose
Allocation
Interventional model
Masking
68 participants in 4 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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