Clinical trial NCT00749411: Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
long-acting beta agonist
Emphysema
Chronic Bronchitis
Chronic Obstructive Pulmonary Disease (COPD)
bronchodilator
long acting muscarinic antagonist
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 61
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Weighted Mean Pulse Rate Over (0-4 Hours) at Day 28.
timeFrame: Baseline (Pre-dose, Day 1) and Day 28
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: On-treatment; from treatment start until one day after treatment stop (Up to Day 29)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Wheat Ridge
country: United States
facility: GSK Investigational Site
state: Colorado
city: Biddeford
country: United States
facility: GSK Investigational Site
state: Maine
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Summit
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Erie
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Johnson City
country: United States
facility: GSK Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Spokane
country: United States
facility: GSK Investigational Site
state: Washington
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.