A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily via a Novel Dry Powder Inhaler in Subjects with Chronic Obstructive Pulmonary Disease (DB2113361)

A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily via a Novel Dry Powder Inhaler in Subjects with Chronic Obstructive Pulmonary Disease (DB2113361) - DB2113361

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36160

Enrollment

100

Registered

2011-02-04

Start date

2011-04-04

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Interventions

Treatment with GSK573719/GW642444, GSK573719, GW642444 or placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • COPD patients >=40 years of age. • (Ex) smokers, at least 10 pack years. • Post salbutamol FEV1/FVC ratio =2 on the Modified Medical Research Council Dyspnea Scale at Visit 1. • Safe contraception for women of childbearing potential.

Exclusion criteria

Exclusion criteria: • Pregnancy. • Bronchial asthma. • Oral steroids in the past 6 weeks. • Hospitalization for COPD or pneumonia in the past 12 weeks. • Significant ECG abnormalities (see protocol for details). • Treatment with specified (mainly COPD) therapies within a specified time frame (see protocol for details). • Previous use of GSK573719, GW642444, the GSK573719/GW642444 combination or the Fluticasone Furoate/GW642444 combination.

Design outcomes

Primary

Measure	Time frame
Change from baseline in trough FEV1 on Day 169.	—

Secondary

Measure	Time frame
PK, PK-PD.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)