28-day Repeat Dose Study of GSK573719

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: GSK573719 125mcg; Drug: Placebo; Drug: GSK573719 500mcg; Drug: GSK573719 250mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01030965

113589

Details and patient eligibility

About

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

Full description

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 3 doses of GSK573719 administered once-daily over 28 days in subjects with COPD.

Enrollment: 285 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 25 to 70% of predicted normal

Exclusion criteria

• Asthma
• Other significant respiratory disorders besides COPD, including alpha-1 deficiency
• Previous lung resection surgery
• Chest X-ray or CP scan showing clinically significant abnormalities not due to COPD
• 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 or clinical lab finding (including Hepatitis B or C)
• Cancer
• Allergy or hypersensitivity to anticholinergics or inhaler excipients
• Diseases that would contraindicate 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
• Participation in acute phase of pulmonary rehabilitation program
• History of alcohol or drug abuse within 2 years prior to screening
• History of psychiatric disease limiting validity of consent
• Affiliation with the investigative site
• Previous use of GSK573719

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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285 participants in 4 patient groups, including a placebo group

GSK573719 125mcg

Experimental group

Description:

125mcg once-daily via novel dry powder inhaler

Treatment:

Drug: GSK573719 125mcg

GSK573719 250mcg

Experimental group

Description:

250mcg once-daily via novel dry powder inhaler

Treatment:

Drug: GSK573719 250mcg

GSK573719 500mcg

Experimental group

Description:

500mcg once-daily via novel dry powder inhaler

Treatment:

Drug: GSK573719 500mcg

Placebo

Placebo Comparator group

Description:

once-daily via novel dry powder inhaler

Treatment:

Drug: Placebo