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OpenTrials
Completed

NCT Number: NCT01030965

28-day Repeat Dose Study of GSK573719

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Disease Disease Attributes Emphysema Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Tallinn, Estonia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK573719 125mcg

Drug

125mcg once-daily

GSK573719 250mcg

Drug

250mcg once-daily

GSK573719 500mcg

Drug

500mcg once-daily

Placebo

Drug

once-daily

Primary outcomes

  1. Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29

    Time frame: 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 Baseline interaction, and day by treatment interaction.

Secondary outcomes

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

    Time frame: 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 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.

  2. Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 14, 2009
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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