A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive; Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: GW856553

Study type: Interventional

Funder types: Industry

Identifiers

NCT00392587

MKI106209

Details and patient eligibility

About

The purpose of this study is to assess the safety of GW856553 in COPD patients and to assess its affects on their COPD disease after 14 days.

Enrollment: 30 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women of childbearing potential
• Established history of COPD
• Cigarette smoking history greater than 10 pack years
• FEV1 between 40 and 80% of predicted normal for height, age and sex.

Exclusion criteria

• Morbidly obese patients (body mass index >40)
• Hospitalisation or treatment for worsening of COPD in past 6 weeks
• History of increased liver function tests
• hypersensitivity to salbutamol or ipratropium bromide
• Blood pressure > 155/95

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind