NCT01039675

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Combination of GSK573719 and GW642444 in Subjects With COPD

Completed Phase 2 Results posted Last updated 8 November 2017

What this trial tests

Phase 2 trial testing 500mcg/25mcg once daily in Pulmonary Disease, Chronic Obstructive in 51 participants. Completed in 20 April 2010.

Timeline

1 January 2010

Primary endpoint
1 April 2010

20 April 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	51
Start date	1 January 2010
Primary completion	1 April 2010
Estimated completion	20 April 2010
Sites	4 locations across United States

Drugs / interventions tested

• 500mcg/25mcg once daily — full drug profile →
• Placebo once daily — full drug profile →

Conditions studied

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

Sponsor

GlaxoSmithKline — full company profile →

Who can join

40 and older, 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 Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at Day 28 Primary · Baseline and Day 28

Pulse rate is defined as the number of heartbeats in a minute. The weighted mean pulse rate was derived by calculating the area under the pulse rate/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean pulse rate was calculated using the 0 to 6 hours post dose measurements at Day 28, which included pre-dose, and post-dose 15 minutes, 45 minutes, 1.5 hours, 3 hours and 6 hours. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the weighted mean pulse rate at Day 28 minus the

Group	Value	95% CI
Placebo	1.4	± 2.20
UMEC/VI 500/25 µg QD	0.9	± 1.05

Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at Day 1 and Day 14 Secondary · Baseline, Day 1, and Day 14

Pulse rate is defined as the number of heartbeats in a minute. The weighted mean pulse rate was derived by calculating the area under the pulse rate/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean pulse rate was calculated using the 0 to 6 hours post dose measurements on Day 1 and Day 14, which included pre-dose, and post-dose 15 minutes, 45 minutes, 1.5 hours, 3 hours and 6 hours. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the weighte

Day 1, n=9, 42

Group	Value	95% CI
Placebo	-1.2	± 2.04
UMEC/VI 500/25 µg QD	-0.6	± 0.92

Day 14, n=9, 39

Group	Value	95% CI
Placebo	-1.7	± 2.70
UMEC/VI 500/25 µg QD	3.1	± 1.26

Change From Baseline in Maximum and Minimum Pulse Rate 0 to 6 Hours Post-dose on Days 1, 14, and 28 Secondary · Baseline, Day 1, Day 14 and Day 28

Pulse rate is defined as the number of heartbeats in a minute (m). A maximum post-Baseline pulse rate was derived as the maximum value recorded at Days 1, 14 and 28. A minimum post-Baseline pulse rate was derived as the minimum value recorded at Days 1, 14 and 28. The maximum and minimum pulse rates were calculated using the 0 to 6 hours (h) post dose measurements on Days 1, 14 and 28, which included pre-dose, and post-dose 15 m, 45 m, 1.5 h, 3 h and 6 h. Maximum and minimum post-Baseline rate were calculated using the nominal 0-6 h post-dose records, and only records collected during the actu

Maximum pulse rate, Day 1, n=9, 42

Group	Value	95% CI
Placebo	4.5	± 2.53
UMEC/VI 500/25 µg QD	6.4	± 1.15

Maximum pulse rate, Day 14, n=9, 40

Group	Value	95% CI
Placebo	4.9	± 2.93
UMEC/VI 500/25 µg QD	9.7	± 1.37

Maximum pulse rate, Day 28, n=9, 35

Group	Value	95% CI
Placebo	7.4	± 2.45
UMEC/VI 500/25 µg QD	6.1	± 1.19

Minimum pulse rate, Day 1, n=9, 42

Group	Value	95% CI
Placebo	-7.0	± 2.10
UMEC/VI 500/25 µg QD	-6.7	± 0.95

Minimum pulse rate, Day 14, n=9, 40

Group	Value	95% CI
Placebo	-7.2	± 2.78
UMEC/VI 500/25 µg QD	-3.2	± 1.28

Minimum pulse rate, Day 28, n=9, 35

Group	Value	95% CI
Placebo	-6.8	± 2.37
UMEC/VI 500/25 µg QD	-5.1	± 1.15

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: 0/9 (0%)

Deaths: —

UMEC/VI 500/25 µg QD

Serious: 0/42 (0%)

Deaths: —

Other adverse events (1 terms — click to expand)

Reaction	System	Placebo	UMEC/VI 500/25 µg QD
Sinusitis	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT01039675 adverse events section.

Sponsor's own description

The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of inhaled GSK573719 and GW64244 compared to placebo, in subjects with COPD.

Publications & conference data

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

1. Once daily long-acting beta2-agonists and long-acting muscarinic antagonists in a combined inhaler versus placebo for chronic obstructive pulmonary disease.
   Maqsood U, Ho TN, Palmer K, Eccles FJ, et al · · 2019 · cited 17× · PMID 30839102 · DOI 10.1002/14651858.cd012930.pub2