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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039675
• Other study ID #: 113120
• Status: Completed
• Phase: Phase 2
• First received: December 23, 2009
• Last updated: October 9, 2017
• Start date: January 1, 2010
• Est. completion date: April 20, 2010

Study information

• Verified date: October 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 20, 2010
• Est. primary completion date: April 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• A signed and dated written informed consent prior to study participation

• Males or females of non-childbearing potential

• 40 or more years of age

• COPD diagnosis

• 10 pack-years history or greater of cigarette smoking

• Post-bronchodilator FEV1/FVC ratio of 0.70 or less

• Post-bronchodilator FEV1 of 80% or less of predicted normal

Exclusion Criteria:

• Current diagnosis of asthma

• Other significant respiratory disorders besides COPD, including alpha-1 deficiency

• Previous lung resection surgery

• Significant abnormalities in chest x-ray presentation

• Use of oral steroids, antibiotics or hospitalization for a COPD exacerbation within 3 motnhs prior screening

• Any significant disease that would put subject at risk through study participation

• BMI greater than 35

• Pacemaker

• Significantly abnormal ECG, Holter, or clinical lab finding (including Hepatitis B or C)

• Cancer

• Allergy or hypersensitivity to anticholinergics or inhaler excipients

• Diseases that would contra-indicate the use of anticholinergics

• Use of oral corticosteroids within 6 weeks of screening

• Use of long-acting beta-agonists within 48 hours of screening

• Use of tiotropium within 14 days of screening

• Use of theophyllines or anti-leukotrienes within 48 hours of screening

• Use of short-acting bronchodilators within 4 hours of screening

• Use of investigational medicines within 30 days of screening

• Use of high dose inhaled corticosteroids

• Use of long-term oxygen therapy, CPAP or NIPPV

• Previous use of GSK573719 or GW642444

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• 500mcg/25mcg once daily
GSK573719/GW642444
• Placebo once daily
Inactive, excipients only

Locations

Country	Name	City	State
United States	GSK Investigational Site	Chester	South Carolina
United States	GSK Investigational Site	Gaffney	South Carolina
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Greenwood	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Feldman G, Walker RR, Brooks J, Mehta R, Crater G. 28-Day safety and tolerability of umeclidinium in combination with vilanterol in COPD: a randomized placebo-controlled trial. Pulm Pharmacol Ther. 2012 Dec;25(6):465-71. doi: 10.1016/j.pupt.2012.08.007. Epub 2012 Aug 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Day 28
Secondary	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.	Baseline, Day 1, and Day 14
Secondary	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.	Baseline, Day 1, Day 14 and Day 28

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.