28-day Repeat Dose Study of GSK573719

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of GSK573719 Delivered Once-daily Over 28 Days in Subjects With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030965
• Other study ID #: 113589
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2009
• Last updated: February 8, 2018
• Start date: December 15, 2009
• Est. completion date: July 4, 2010

Study information

• Verified date: February 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 3 doses of GSK573719 administered once-daily over 28 days in subjects with COPD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: July 4, 2010
• Est. primary completion date: July 4, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

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

• Males or females of non-childbearing potential

• 40 to 80 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 25 to 70% of predicted normal

Exclusion Criteria:

• Asthma

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

• Previous lung resection surgery

• Chest X-ray or CP scan showing clinically significant abnormalities not due to COPD

• Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening

• Hospitalization for COPD or pneumonia within 3 months of screening

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

• BMI greater than 35

• Pacemaker

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

• Cancer

• Allergy or hypersensitivity to anticholinergics or inhaler excipients

• Diseases that would contraindicate 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 to 6 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

• Participation in acute phase of pulmonary rehabilitation program

• History of alcohol or drug abuse within 2 years prior to screening

• History of psychiatric disease limiting validity of consent

• Affiliation with the investigative site

• Previous use of GSK573719

Related Conditions & MeSH terms

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

Intervention

Drug:
• GSK573719 125mcg
125mcg once-daily
• GSK573719 250mcg
250mcg once-daily
• GSK573719 500mcg
500mcg once-daily
• Placebo
once-daily

Locations

Country	Name	City	State
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Grosshansdorf	Schleswig-Holstein
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Wiesbaden	Hessen
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Gidle
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lublin
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Madisonville	Kentucky
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Union	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Estonia,  Germany,  Poland, 

References & Publications (1)

Decramer M, Maltais F, Feldman G, Brooks J, Harris S, Mehta R, Crater G. Bronchodilation of umeclidinium, a new long-acting muscarinic antagonist, in COPD patients. Respir Physiol Neurobiol. 2013 Jan 15;185(2):393-9. doi: 10.1016/j.resp.2012.08.022. Epub 2012 Sep 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at 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 Baseline interaction, and day by treatment interaction.	Baseline and Day 29
Secondary	Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at 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 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 weighted mean at Days 1 and 28 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline, country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.	Baseline, Day 1, and Day 28
Secondary	Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at 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.	Baseline, Day 1, and Day 28

External Links

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