Last updated: 11/07/2018 05:40:41

Safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of GSK573719 and GW642444 in subjects with COPD

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GSK study ID
113120
See study documents
Clinicaltrials.gov ID
NCT01039675
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of GSK573719 and GW642444 in subjects with COPD
Trial description: The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of the combination of inhaled GSK573719 and GW64244 compared to placebo, in subjects with COPD.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Change from Baseline in weighted mean pulse rate over 0 to 6 hours post-dose at Day 28

Timeframe: Baseline and Day 28

Secondary outcomes:

Change from Baseline in weighted mean pulse rate over 0 to 6 hours post-dose at Day 1 and Day 14

Timeframe: Baseline, Day 1, and Day 14

Change from Baseline in maximum and minimum pulse rate 0 to 6 hours post-dose on Days 1, 14, and 28

Timeframe: Baseline, Day 1, Day 14 and Day 28

Interventions:
Drug: 500mcg/25mcg once daily
Drug: Placebo once daily
Enrollment:
51
Observational study model:
Not applicable
Primary completion date:
2010-20-04
Time perspective:
Not applicable
Clinical publications:
Feldman G, Walker RR, Brooks J, Mehta R, Crater G. 28-day safety and tolerability of umeclidinium in combination with vilanterol in COPD: a randomized placebo-controlled trial. Pulm Pharmacol Ther. 2012;25(6):465-71.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, vilanterol
Collaborators
GSK
Study date(s)
January 2010 to April 2010
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
  • A signed and dated written informed consent prior to study participation
  • Males or females of non-childbearing potential
  • Current diagnosis of asthma
  • Other significant respiratory disorders besides COPD, including alpha-1 deficiency
Inclusion and exclusion criteria
Inclusion criteria:
  • A signed and dated written informed consent prior to study participation
  • Males or females of non-childbearing potential
  • 40 or more 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 80% or less of predicted normal
Exclusion criteria:
  • Current diagnosis of asthma
  • Other significant respiratory disorders besides COPD, including alpha-1 deficiency
  • Previous lung resection surgery
  • Significant abnormalities in chest x-ray presentation
  • Use of oral steroids, antibiotics or hospitalization for a COPD exacerbation within 3 motnhs prior screening
  • Any significant disease that would put subject at risk through study participation
  • BMI greater than 35
  • Pacemaker
  • Significantly abnormal ECG, Holter, or clinical lab finding (including Hepatitis B or C)
  • Cancer
  • Allergy or hypersensitivity to anticholinergics or inhaler excipients
  • Diseases that would contra-indicate 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 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
  • Previous use of GSK573719 or GW642444

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Greenwood, South Carolina, United States, 29646
Status
Study Complete
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Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
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Location
GSK Investigational Site
Gaffney, South Carolina, United States, 29340
Status
Study Complete
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Location
GSK Investigational Site
Chester, South Carolina, United States, 29706
Status
Study Complete
Contact us

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2010-20-04
Actual study completion date
2010-20-04

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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