NCT01030965

28-day Repeat Dose Study of GSK573719

Completed Phase 2 Results posted Last updated 9 March 2018

What this trial tests

Phase 2 trial testing GSK573719 125mcg in Pulmonary Disease, Chronic Obstructive in 285 participants. Completed in 4 July 2010.

Timeline

15 December 2009

Primary endpoint
4 July 2010

4 July 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	285
Start date	15 December 2009
Primary completion	4 July 2010
Estimated completion	4 July 2010
Sites	20 locations across Estonia, United States, Germany, Poland

Drugs / interventions tested

• GSK573719 125mcg — full drug profile →
• GSK573719 250mcg — full drug profile →
• GSK573719 500mcg — full drug profile →
• Placebo

Conditions studied

• Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 40 to 80, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29 Primary · Baseline and Day 29

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 29 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 28. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between trough on Day 29 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline (BL), country, sex, age, treatment, smoking status, day, day by Base

Group	Value	95% CI
Placebo	0.013	± 0.025
UMEC 125 µg	0.171	± 0.025
UMEC 250 µg	0.181	± 0.025
UMEC 500 µg	0.163	± 0.025

Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28 Secondary · Baseline, Day 1, and Day 28

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean was calculated using the 0-6 hour post-dose measurements at Days 1 and 28, which included pre-dose (30 minutes prior to dosing on Day 1, or 24 hours after the previous day's dose on Day 28), and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Baseline is defined

Day 1, n=70, 70, 71, 70

Group	Value	95% CI
Placebo	0.005	± 0.015
UMEC 125 µg	0.211	± 0.015
UMEC 250 µg	0.224	± 0.014
UMEC 500 µg	0.173	± 0.015

Day 28, n=65, 64, 68, 64

Group	Value	95% CI
Placebo	0.009	± 0.024
UMEC 125 µg	0.220	± 0.024
UMEC 250 µg	0.204	± 0.023
UMEC 500 µg	0.122	± 0.024

Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28 Secondary · Baseline, Day 1, and Day 28

Serial spirometry assessments were conducted on Day 1 and Day 28 over the course of 24 hours and were obtained 0 (Day 28 only), 1, 3, 6, 23, and 24 hours after dosing. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between FEV1 on Days 1 and 28 and Baseline.

Day 1, 1 hour, n=70, 71, 72, 71

Group	Value	95% CI
Placebo	0.013	± 0.015
UMEC 125 µg	0.196	± 0.015
UMEC 250 µg	0.212	± 0.015
UMEC 500 µg	0.145	± 0.015

Day 1, 3 hours, n=70, 71, 72, 71

Group	Value	95% CI
Placebo	0.008	± 0.018
UMEC 125 µg	0.255	± 0.018
UMEC 250 µg	0.274	± 0.018
UMEC 500 µg	0.227	± 0.018

Day 1, 6 hours, n=70, 71, 72, 70

Group	Value	95% CI
Placebo	-0.004	± 0.019
UMEC 125 µg	0.232	± 0.019
UMEC 250 µg	0.221	± 0.019
UMEC 500 µg	0.186	± 0.019

Day 1, 23 hours, n=70, 70, 72, 70

Group	Value	95% CI
Placebo	-0.036	± 0.019
UMEC 125 µg	0.171	± 0.019
UMEC 250 µg	0.186	± 0.019
UMEC 500 µg	0.107	± 0.019

Day 1, 24 hours, n=69, 71, 72, 70

Group	Value	95% CI
Placebo	-0.002	± 0.019
UMEC 125 µg	0.211	± 0.018
UMEC 250 µg	0.216	± 0.018
UMEC 500 µg	0.153	± 0.018

Day 28, 0 hours, n=67, 64, 69, 65

Group	Value	95% CI
Placebo	-0.017	± 0.024
UMEC 125 µg	0.165	± 0.024
UMEC 250 µg	0.203	± 0.024
UMEC 500 µg	0.140	± 0.024

Day 28, 1 hour, n=67, 64, 68, 65

Group	Value	95% CI
Placebo	-0.008	± 0.025
UMEC 125 µg	0.207	± 0.026
UMEC 250 µg	0.182	± 0.025
UMEC 500 µg	0.067	± 0.026

Day 28, 3 hours, n=67, 65, 67, 64

Group	Value	95% CI
Placebo	0.008	± 0.026
UMEC 125 µg	0.267	± 0.026
UMEC 250 µg	0.204	± 0.026
UMEC 500 µg	0.168	± 0.026

Adverse events — posted to ClinicalTrials.gov

Time frame: On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 0/71 (0%)

Deaths: —

UMEC 125 µg

Serious: 1/71 (1%)

Deaths: —

UMEC 250 µg

Serious: 1/72 (1%)

Deaths: —

UMEC 500 µg

Serious: 1/71 (1%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	Placebo	UMEC 125 µg	UMEC 250 µg	UMEC 500 µg
Retinal detachment	Eye disorders	—	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Placebo	UMEC 125 µg	UMEC 250 µg	UMEC 500 µg
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—

Most-reported serious reactions: Retinal detachment, Gastroenteritis viral, Chronic obstructive pulmonary disease.

Data from ClinicalTrials.gov NCT01030965 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mechanisms, Pathophysiology and Currently Proposed Treatments of Chronic Obstructive Pulmonary Disease.
   Rodrigues SO, Cunha CMCD, Soares GMV, Silva PL, et al · · 2021 · cited 61× · PMID 34681202 · DOI 10.3390/ph14100979