Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD
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
1 other identifier
interventional
61
1 country
12
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2008
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2008
CompletedFirst Posted
Study publicly available on registry
September 9, 2008
CompletedStudy Start
First participant enrolled
November 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2009
CompletedResults Posted
Study results publicly available
September 1, 2020
CompletedSeptember 1, 2020
August 1, 2020
3 months
September 8, 2008
May 2, 2017
August 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Weighted Mean Pulse Rate Over (0-4 Hours) at 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).
Baseline (Pre-dose, Day 1) and Day 28
Secondary Outcomes (1)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
On-treatment; from treatment start until one day after treatment stop (Up to Day 29)
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
The combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (12)
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Wheat Ridge, Colorado, 80033, United States
GSK Investigational Site
Biddeford, Maine, 04005, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Summit, New Jersey, 07091, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Erie, Pennsylvania, 16508, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Johnson City, Tennessee, 37601, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
Related Publications (1)
GSK has submitted manuscripts of these study results to peer-reviewed scientific journals which were not accepted for publication. GSK is providing the attached study results summary with a conclusion.
BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2008
First Posted
September 9, 2008
Study Start
November 13, 2008
Primary Completion
February 12, 2009
Study Completion
February 12, 2009
Last Updated
September 1, 2020
Results First Posted
September 1, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.