Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma
A Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study to Evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients With Severe Asthma
1 other identifier
interventional
198
8 countries
35
Brief Summary
Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Dec 2008
Typical duration for phase_2 asthma
35 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
Study Start
First participant enrolled
December 9, 2008
CompletedFirst Submitted
Initial submission to the registry
February 5, 2009
CompletedFirst Posted
Study publicly available on registry
February 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2010
CompletedResults Posted
Study results publicly available
December 12, 2017
CompletedDecember 12, 2017
November 1, 2017
1.6 years
February 5, 2009
September 26, 2017
November 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Asthma Control Questionnaire (ACQ-7) Over 12 Weeks
The ACQ-7 consists of 7 questions scored between zero (no impairment/ limitation) to 6 (total impairment/ limitation). The values of Week 1 is considered as Baseline. ACQ-7 was calculated as the average of the 7 scores. If any one individual score was missing, the ACQ-7 was set to missing.The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value was missing, the change from Baseline was set to missing as well.
Baseline to Week 12
Secondary Outcomes (16)
Change From Baseline in ACQ-7 Over 16 Weeks and 24 Weeks
Week 16 and Week 24
Number of Participants Who Demonstrated a Clinically Meaningful Change in ACQ-7 Over the 12 Weeks Assessment Period.
Upto 12 weeks
Change From Baseline in Forced Expiratory Volume (FEV1) Over 12 Weeks.
Baseline to Week 12
Change From Baseline in FEV1 Over 16 Weeks and 24 Weeks
Week 16 and 24
Percentage of Participants Who Demonstrated a Clinically Meaningful Increase in FEV1 Over the 12 Week Assessment Period
Upto 12 weeks
- +11 more secondary outcomes
Study Arms (2)
GSK679586
EXPERIMENTALSubjects will receive three, once monthly intravenous administration of 10 mg/kg of GSK679586, according to randomization
PLACEBO
PLACEBO COMPARATORSubjects will receive three, once monthly intravenous administration of saline, according to randomization
Interventions
GSK679586 will be provided as a clear or colorless to pale yellow liquid with the unit dose strength of 10mg/kg and will be infused over an hour. The infusion will be delivered by a programmable infusion pump
Clear or colorless 0.9% sodium chloride saline solution will be infused over an hour. The infusion will be delivered by a programmable infusion pump
Subjects will be supplied fluticasone propionate at Screening, Run-in and when needed during the study. Subjects will be up-titrated to 1000 μg/day and those who were already taking greater than equal to 1000 μg/day fluticasone propionate or equivalent prior to the study will remain on their pre-study dose.
Eligibility Criteria
You may qualify if:
- history of asthma for ≥ 6 months
- taking inhaled corticosteroids
- non-smoking
- Baseline (pre-bronchodilator) FEV1 35-80% predicted at screening.
- Reversible airways disease as indicated by an increase of FEV1 ≥12% from baseline after nebulised salbutamol or albuterol.
- symptomatic according to the ACQ-7
You may not qualify if:
- Unstable severe asthma
- Recent respiratory illness
- Presence of other respiratory disease or chronic pulmonary condition other than asthma
- Treatment with omalizumab within 4 months of study
- Recent gastrointestinal or respiratory parasitic infestation
- History of severe allergy to food or drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (35)
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Portland, Oregon, 97213, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, PA 15213, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Boerne, Texas, 78006, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
GSK Investigational Site
Lille, 59037 cedex, France
GSK Investigational Site
Marseille, 13009, France
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Saint-Pierre, 97448, France
GSK Investigational Site
Strasbourg, 67091, France
GSK Investigational Site
Tarbes, 65013, France
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Gelnhausen, Hesse, 63571, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112, Germany
GSK Investigational Site
Eindhoven, 5623 EJ, Netherlands
GSK Investigational Site
Heerlen, 6419 PC, Netherlands
GSK Investigational Site
Hoorn, 1624 NP, Netherlands
GSK Investigational Site
Elverum, 2408, Norway
GSK Investigational Site
Trondheim, 7006, Norway
GSK Investigational Site
Bialystok, 15-276, Poland
GSK Investigational Site
Gidle, 97-540, Poland
GSK Investigational Site
Krakow, 31-023, Poland
GSK Investigational Site
Lodz, 90-153, Poland
GSK Investigational Site
Warsaw, 02-097, Poland
GSK Investigational Site
Cape Town, Gauteng, 7505, South Africa
GSK Investigational Site
Bellville, 7530, South Africa
GSK Investigational Site
Bloemfontein, 9301, South Africa
GSK Investigational Site
Mowbray, 7700, South Africa
GSK Investigational Site
Southampton, Hampshire, SO16 6YD, United Kingdom
GSK Investigational Site
Guildford, Surrey, GU2 7XP, United Kingdom
GSK Investigational Site
Belfast, BT9 7AB, United Kingdom
GSK Investigational Site
London, SE1 1YR, United Kingdom
GSK Investigational Site
Nottingham, NG5 1PB, United Kingdom
Related Publications (1)
Anderson WH, Koshy BT, Huang L, Mosteller M, Stinnett SW, Condreay LD, Ortega H. Genetic analysis of asthma exacerbations. Ann Allergy Asthma Immunol. 2013 Jun;110(6):416-422.e2. doi: 10.1016/j.anai.2013.04.002.
PMID: 23706709DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
February 5, 2009
First Posted
February 13, 2009
Study Start
December 9, 2008
Primary Completion
July 25, 2010
Study Completion
July 25, 2010
Last Updated
December 12, 2017
Results First Posted
December 12, 2017
Record last verified: 2017-11
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.