Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00843193
First received: February 5, 2009
Last updated: September 19, 2013
Last verified: February 2012

February 5, 2009
September 19, 2013
December 2008
July 2010   (final data collection date for primary outcome measure)
To evaluate the efficacy of repeat intravenous dose administration of GSK679586 in patients with severe asthma by assessing the changes from baseline in Asthma Control Questionnaire (ACQ7) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
To evaluate the efficacy of repeat intravenous dose administration of GSK679586 in patients with severe asthma by assessing the changes from baseline in Asthma Control Questionnaire (ACQ7) [ Time Frame: Over 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00843193 on ClinicalTrials.gov Archive Site
Effect of GSK679586 on the changes from baseline in FEV1 and ACQ-7, safety and tolerability, PK and immunogenicity [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • To evaluate the effect of GSK679586 with respect to FEV1 and ACQ-7 for other designated efficacy windows by assessing the changes from baseline in FEV1 and ACQ-7 [ Time Frame: Over 12, 16 and 24 weeks ] [ Designated as safety issue: No ]
  • To evaluate the safety & tolerability of repeat intravenous dose administration of GSK679586 in patients with severe asthma by measuring adverse events, vital signs, 12-lead electrocardiogram (ECG) and clinical safety laboratory parameters [ Time Frame: Approximately 37 weeks ] [ Designated as safety issue: Yes ]
  • To evaluate the plasma pharmacokinetics (PK) of repeat intravenous doses of GSK679586 in patients with severe asthma by measuring plasma PK parameters of GSK679586 including: AUC(0-tau), Cmax, CL and.V [ Time Frame: Approximately 37 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study

A Multi-Centre, Multi-conutry, Randomized, Double-Blind (Subject, Investigator), Placebo-Controlled, Repeat-Dose study to evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients with Severe Asthma

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: Active GSK679586
    Drug: GSK679586
  • Drug: Placebo
    Placebo treatment
  • Active Comparator: Active GSK679586
    Drug: GSK679586
    Interventions:
    • Drug: Active GSK679586
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo: saline
    Interventions:
    • Drug: Active GSK679586
    • Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   United States,   France,   United Kingdom,   Netherlands,   Norway,   Poland,   South Africa
 
NCT00843193
106870
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP