Last updated: 11/04/2018 08:19:21

A Study To Assess Single Dosage Strength Of GW685698/GW642444 Chronic Obstructive Pulmonary Disease (COPD)

GSK study ID
HZC111348
Clinicaltrials.gov ID
EudraCT ID
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: Study HZC111348, a repeat-dose study of GW685698/GW642444 Inhalation Powder versus Placebo in the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Trial description: The purpose of this study is to assess the safety and efficacy of a single dosage strength of GW685698/GW642444 in subjects with Chronic Obstructive Pulmonary Disease (COPD).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Change from Baseline in weighted mean heart rate 0-4 hours post-dose at the end of the 28-day treatment period

Timeframe: Baseline to Day 28

Number of participants with any adverse event (AE) and any serious adverse event (SAE) throughout the study

Timeframe: From Baseline (Day 1) until Follow-up (up to Study Day 37)

Secondary outcomes:

Mean change from Baseline in clinic visit trough forced expiratory volume in one second (FEV1) on Days 2, 15, and 29

Timeframe: Baseline; Day 2, Day 15, and Day 29

Mean change from Baseline (pre-dose on Day 1) in weighted mean FEV1 (0-4 hours post-dose) on Days 1 and 28

Timeframe: Baseline (pre-dose on Day 1); Day 1 and Day 28

Interventions:
Drug: GW685698/GW642444
Enrollment:
60
Observational study model:
Not applicable
Primary completion date:
2009-25-02
Time perspective:
Not applicable
Clinical publications:
Lötvall J, Bakke P, Bjermer L, Steinshamn S, Crim C, Sanford L, Scott-Wilson C, Haumann B. Efficacy and safety of 4 weeks' treatment with combined fluticasone furoate/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial. [BMJ Open]. 2012;2(1):e000370.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, vilanterol
Collaborators
Not applicable
Study date(s)
August 2008 to February 2009
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
  • Subjects eligible for enrollment in the study must meet all of the following criteria:
  • 1. Informed consent: Subjects must give their signed written informed consent to participate.
  • Subjects meeting any of the following criteria must not be enrolled in the study:
  • 1. Pregnancy: Women who are pregnant or lactating

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
STOCKHOLM, Sweden, SE-118 83
Status
Study Complete
Location
GSK Investigational Site
Trondheim, Norway, 7030
Status
Study Complete
Location
GSK Investigational Site
Sandvika, Norway, 1337
Status
Study Complete
Location
GSK Investigational Site
LULEÅ, Sweden, SE-971 89
Status
Study Complete
Location
GSK Investigational Site
LUND, Sweden, SE-221 85
Status
Study Complete
Location
GSK Investigational Site
Fredrikstad, Norway, 1606
Status
Study Complete
Location
GSK Investigational Site
GÖTEBORG, Sweden, SE-413 45
Status
Study Complete
Location
GSK Investigational Site
Elverum, Norway, 2408
Status
Study Complete
Location
GSK Investigational Site
Bergen, Norway, 5053
Status
Study Complete

Study documents

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

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
2009-25-02
Actual study completion date
2009-25-02

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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