A randomized, parallel group study to evaluate the effect of Umeclidinium (UMEC) added to Inhaled corticosteroid/ long-acting beta-agonist combination therapy in subjects with Chronic Obstructive Pulmonary Disease COPD (study 201314)

Phase 4

Completed

• Conditions: COPD; chronic obstructive pulmonary disease; 10038716

• Registration Number: NL-OMON41117
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

* 40 years of age or above.
* An established clinical history of COPD in accordance with the definition by the ATS/ERS.
* Current or former cigarette smokers with a history of cigarette smoking of *10 pack-years (see protocol page 26 for details).
* Pre and post-salbutamol FEV1/FVC ratio of <0.70 and post-salbutamol FEV1 of *70% of predicted.
* Must be on the dose and frequency of one of the ICS/LABA combinations approved for COPD and for the study at least 30 days prior screening (see protocol page 26-27 for details).
* Score of *2 on the mMRC.
* Females of childbearing potential: adequate method of contraception. See protocol page 26 for details.

Exclusion Criteria

* Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
* Lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1.
* Unstable or life threatening cardiac disease. See protocol page 27-28 for details.
* Defined prior therapies. See protocol page 28-29 for details.
* Pregnancy or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Trough FEV1 on day 85, Incidence of adverse events.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Main: Weighted mean 0-6 hour FEV1 obtained post-dose on Treatment Day 84.</p><br>