Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Combination of GSK573719 and GW642444 in Subjects With COPD

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: 500mcg/25mcg once daily; Drug: Placebo once daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT01039675

113120

Details and patient eligibility

About

The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of inhaled GSK573719 and GW64244 compared to placebo, in subjects with COPD.

Full description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of the combination of GSK573719 (500mcg) Inhalation Powder and GW642444 (25mcg) Inhalation Powder administered once-daily via a novel dry powder inhaler (Novel DPI) over 28 days in subjects with COPD

Enrollment: 51 patients

Sex: All

Ages: 40+ 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 or more 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 80% or less of predicted normal

Exclusion criteria

• Current diagnosis of asthma
• Other significant respiratory disorders besides COPD, including alpha-1 deficiency
• Previous lung resection surgery
• Significant abnormalities in chest x-ray presentation
• Use of oral steroids, antibiotics or hospitalization for a COPD exacerbation within 3 motnhs prior 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 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 or GW642444

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups, including a placebo group

GSK573719/GW642444

Experimental group

Treatment:

Drug: 500mcg/25mcg once daily

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo once daily