A Phase 2 interventional study of 500mcg/25mcg once daily and Placebo once daily in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 4 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-11-08.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of inhaled GSK573719 and GW64244 compared to placebo, in subjects with COPD.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of the combination of GSK573719 (500mcg) Inhalation Powder and GW642444 (25mcg) Inhalation Powder administered once-daily via a novel dry powder inhaler (Novel DPI) over 28 days in subjects with COPD
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 51 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.
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Exclusion Criteria:
Drug: 500mcg/25mcg once daily
Drug: Placebo once daily
GSK573719/GW642444
Inactive, excipients only
Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at 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 Baseline value. Analysis was performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.
Time frame: Baseline and Day 28
Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at 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 weighted mean pulse rate at Day 1 or Day 14 minus the Baseline value. Analysis was performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.
Time frame: Baseline, Day 1, and Day 14
Change From Baseline in Maximum and Minimum Pulse Rate 0 to 6 Hours Post-dose on Days 1, 14, and 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 actual 0-7 h post-dose interval were used. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the maximum or minimum pulse rate minus the Baseline value. Analysis performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.
Time frame: Baseline, Day 1, Day 14 and Day 28
| Milestone | Placebo | UMEC/VI 500/25 µg QD |
|---|---|---|
| Started | 9 | 42 |
| Completed | 9 | 35 |
| Not completed | 0 | 7 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Lack of efficacy | 0 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Physician decision | 0 | 1 |
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 Baseline value. Analysis was performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.
| Beats per minutes (bpm) | Placebo | UMEC/VI 500/25 µg QD |
|---|---|---|
| Change From Baseline in Weighted Mean Pulse Rate Over 0 to 6 Hours Post-dose at Day 28 | 1.4 ± 2.20 | 0.9 ± 1.05 |
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 weighted mean pulse rate at Day 1 or Day 14 minus the Baseline value. Analysis was performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.
| Beats per minutes | Placebo | UMEC/VI 500/25 µg QD |
|---|---|---|
| Day 1, n=9, 42 | -1.2 ± 2.04 | -0.6 ± 0.92 |
| Day 14, n=9, 39 | -1.7 ± 2.70 | 3.1 ± 1.26 |
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 actual 0-7 h post-dose interval were used. Baseline pulse rate is the most recent result taken on or before pre-dose Day 1. Change from Baseline is the maximum or minimum pulse rate minus the Baseline value. Analysis performed using a repeated measures model with covariates of Baseline pulse rate, sex, age, smoking status, treatment and day and day by treatment and day by Baseline interactions.
| Beats per minutes | Placebo | UMEC/VI 500/25 µg QD |
|---|---|---|
| Maximum pulse rate, Day 1, n=9, 42 | 4.5 ± 2.53 | 6.4 ± 1.15 |
| Maximum pulse rate, Day 14, n=9, 40 | 4.9 ± 2.93 | 9.7 ± 1.37 |
| Maximum pulse rate, Day 28, n=9, 35 | 7.4 ± 2.45 | 6.1 ± 1.19 |
| Minimum pulse rate, Day 1, n=9, 42 | -7.0 ± 2.10 | -6.7 ± 0.95 |
| Minimum pulse rate, Day 14, n=9, 40 | -7.2 ± 2.78 | -3.2 ± 1.28 |
| Minimum pulse rate, Day 28, n=9, 35 | -6.8 ± 2.37 | -5.1 ± 1.15 |
Collected over On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/9 (0%) | 1/9 (11.1%) |
| UMEC/VI 500/25 µg QD | — | 0/42 (0%) | 1/42 (2.4%) |
| Event | Placebo | UMEC/VI 500/25 µg QD |
|---|---|---|
| SinusitisInfections and infestations | 1/9 | 1/42 |
| Age, Continuous(Years) | Placebo | UMEC/VI 500/25 µg QD | Total |
|---|---|---|---|
| Mean | 58.7 ± 9.77 | 59.2 ± 9.48 | 59.1 ± 9.43 |
| Sex: Female, Male(Participants) | Placebo | UMEC/VI 500/25 µg QD | Total |
|---|---|---|---|
| Female | 2 | 18 | 20 |
| Male | 7 | 24 | 31 |
| Race/Ethnicity, Customized(Participants) | Placebo | UMEC/VI 500/25 µg QD | Total |
|---|---|---|---|
| African American/African Heritage | 1 | 6 | 7 |
| White | 8 | 36 | 44 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →