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Completed

NCT Number: NCT00749411

Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD

The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the combination of inhaled GSK233705 and GW642444 administered once-daily 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, Mobile, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male and females 40 to 80 years of age (inclusive)
  • COPD diagnosis
  • Current or previous smokers with a cigarette smoking history of at least 10 pack-
  • Post-albuterol FEV1/FVC of 0.70 or less
  • Post-albuterol FEV1 of 35% to 80% (inclusive)

Exclusion criteria

  • Pregnant or lactating females
  • current diagnosis of asthma
  • respiratory disorders other than COPD
  • clinically significant cardiovascular, neurological, psychiatric, renal, immunological, endocrine, or hematological abnormalities that are uncontrolled
  • clinically significant sleep apnea
  • previous lung resection surgery
  • clinically significant abnormalities confirmed by chest x-ray that are not related to COPD
  • hospitalization for COPD within 3 months of screening
  • use of antibiotics for lower respiratory tract infection within 6 months of screening
  • abnormal and clinically significant 12-lead ECG findings
  • current malignancy in remission for less that 5 years
  • medical conditions that would contraindicate the use of anticholinergics
  • positive hepatitis B or C test
  • history of alcohol or drug abuse
  • unable to withhold albuterol for 6 or more hours
  • use of long term oxygen therapy
  • conditions that would limit the validity of informed consent
  • use of GW642444 or GSK233705 in previous studies
  • use of an investigation drug with 30 days of screening
  • use of inhaled corticosteroids (ICS) at a dose greater than 1000mcg of fluticasone propionate or equivalent
  • hypersensitivity to beta-agonists
  • concurrent use of long-acting beta-agonists (LABA) or long-acting muscaring antagonists, LABA/ICS combination products, cytochrome p450 inhibitors, oral or depot corticosteroids, theophyllines, oral beta agonists, oral leukotrine modulators, inhaled short acting anticholinergics.

Treatment and study plan

Placebo

Drug

matching placebo

GSK233705/GW642444

Drug

The combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler.

Primary outcomes

  1. Change From Baseline in Weighted Mean Pulse Rate Over (0-4 Hours) at Day 28.

    Time frame: Baseline (Pre-dose, Day 1) and Day 28

    Baseline was the most recent result taken on or before pre-dose (Day 1). The analysis was performed using a Repeated Measures Model. This model used all available weighted mean pulse rate values recorded. Change from Baseline was calculated as (Change from Baseline = Assessment value - Baseline value).

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: On-treatment; from treatment start until one day after treatment stop (Up to Day 29)

    AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, 4-week Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Inhaled Doses of the Combination of GSK233705 and GW642444 Administered Once-daily in Subjects With COPD

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 9, 2008
Registry last updated
Sep 1, 2020

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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