A 4-week Dose-Ranging, Dose-Interval, Efficacy, Safety and Tolerability Study of GSK961081 in Subjects with COPD.

Phase 2

Completed

• Conditions: COPD; 10038716

• Registration Number: NL-OMON36391
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

• COPD patients >=40 years of age.
• (Ex) smokers, at least 10 pack years.
• Post salbutamol FEV1/FVC ratio <70%.
• Post salbutamol FEV1 30-70% of predicted.
• Safe contraception for women of childbearing potential.

Exclusion Criteria

• Pregnancy.
• Bronchial asthma.
• Oral steroids in the past 6 weeks.
• Hospitalization in the past 12 weeks for COPD or pneumonia.
• Antibiotics for lower respiratory tract infection in the past 6 weeks.
• BMI >35 kg/m2.
• Pacemaker.
• Significant ECG abnormalities (see protocol for details).
• Contraindications for the use of anticholinergics.
• Treatment with specified (mainly COPD) therapies within a specified time frame (see protocol for details).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change from baseline in trough FEV1 on Day 29.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Weighted mean for 0 to 24 H serial FEV1, other pulmonary function parameters,<br /><br>adverse events, exacerbations, PK, PK-PD.</p><br>