GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Tiotropium; Drug: Placebo; Drug: GSK573179

Study type: Interventional

Funder types: Industry

Identifiers

NCT00950807

113073

Details and patient eligibility

About

The study will evaluate the dose response, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD.

Full description

This is multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-way cross-over, incomplete block design study to evaluation of 5 doses of GSK573719 administered once-daily and 3 doses of GSK573719 administered twice-daily over 14 days in subjects with COPD and will include tiotropium as an open-label active control. The pharmacokinetic profile of GSK573719 will also be evaluated.

Enrollment: 176 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A signed and dated written informed consent prior to study participation
• Males or females of non-childbearing potential
• 40 to 80 years of age
• COPD diagnosis
• 10 pack-years history or greater of cigarette smoking
• Post-bronchodilator FEV1/FVC ratio of 0.70 or less
• Post-bronchodilator FEV1 of 35 to 70% of predicted normal

Exclusion criteria

• Asthma
• Other significant respiratory disorders besides COPD, including alpha-1 deficiency
• Previous lung resection surgery
• Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening
• Hospitalization for COPD or pneumonia within 3 months of screening
• Any significant disease that would put subject at risk through study participation
• BMI greater than 35
• Pacemaker
• Significantly abnormal ECG, Holter, or clinical lab finding (including Hepatitis B or C)
• Cancer
• Allergy or hypersensitivity to anticholinergics or inhaler excipients
• Diseases that would contra-indicate the use of anticholinergics
• Use of oral corticosteroids within 6 weeks of screening
• Use of long-acting beta-agonists within 48 hours of screening
• Use of tiotropium within 14 days of screening
• Use of theophyllines or anti-leukotrienes within 48 hours of screening
• Use of short-acting bronchodilators within 4 to 6 hours of screening
• Use of investigational medicines within 30 days of screening
• Use of high dose inhaled corticosteroids
• Use of long-term oxygen therapy, CPAP or NIPPV
• Previous use of GSK573719

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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176 participants in 10 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Tiotropium

Active Comparator group

Description:

Tiotropium

Treatment:

Drug: Tiotropium

Arm 1

Experimental group

Description:

GSK573719 1000mcg once daily

Treatment:

Drug: GSK573179

Arm 2

Experimental group

Description:

GSK573719 500mcg once daily

Treatment:

Drug: GSK573179

Arm 3

Experimental group

Description:

GSK573719 250mcg once daily

Treatment:

Drug: GSK573179

Arm 4

Experimental group

Description:

GSK573719 125mcg once daily

Treatment:

Drug: GSK573179

Arm 5

Experimental group

Description:

GSK573719 62.5 mcg once daily

Treatment:

Drug: GSK573179

Arm 6

Experimental group

Description:

GSK573719 250mcg twice daily

Treatment:

Drug: GSK573179

Arm 7

Experimental group

Description:

GSK573719 125mcg twice daily

Treatment:

Drug: GSK573179

Arm 8

Experimental group

Description:

GSK573719 62.5mcg twice daily

Treatment:

Drug: GSK573179