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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: April 13, 2017
Last verified: April 2017
February 5, 2009
April 13, 2017
December 9, 2008
July 25, 2010   (Final data collection date for primary outcome measure)
Change from baseline in Asthma Control Questionnaire (ACQ-7) over 12 weeks [ Time Frame: Throughout the study ]
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 ]
Complete list of historical versions of study NCT00843193 on ClinicalTrials.gov Archive Site
  • Change from baseline in FEV1 over 12 weeks [ Time Frame: Baseline and Week 12 ]
  • Percentage of participants who demonstrated a clinically meaningful change in ACQ-7 over the 12 weeks assessment period [ Time Frame: Baseline and Week 12 ]
  • Percentage of participants who demonstrated a clinically meaningful increase in FEV1 over the 12 week assessment period [ Time Frame: Baseline and Week 12 ]
  • Change from baseline in ACQ-7 over 16 weeks and 24 weeks [ Time Frame: Baseline, Week 16 and 24 ]
  • Change from baseline in FEV1 over 16 weeks and 24 weeks [ Time Frame: Baseline, Week 16 and Week 24 ]
  • Number of participants with any Adverse events (AEs) and serious adverse event [ Time Frame: Up to week 37 ]
  • Number of participants with abnormal vital signs of potential clinical importance: Systolic and distolic blood pressure [ Time Frame: Up to Week 37 ]
  • Number of participants with abnormal vital signs of potential clinical importance: Heart rate [ Time Frame: Up to Week 37 ]
  • Number of participants with abnormality in 12-lead electrocardiogram (ECG) [ Time Frame: Up to Week 37 ]
  • Number of participants with abnormal hematological parameters of potential clinical importance [ Time Frame: Up to Week 37 ]
  • Number of participants with abnormal clinical chemistry parameters of potential clinical importance [ Time Frame: Up to Week 37 ]
  • Number of participants with abnormal urinalysis parameters of potential clinical importance [ Time Frame: Up to Week 37 ]
  • Plasma PK parameters of GSK679586: Area under the concentration-time curve over the dosing interval (AUC(0-τ)) [ Time Frame: Day 1, 29, 57 ]
  • Plasma PK parameters of GSK679586: Maximum observed concentration (Cmax) [ Time Frame: Day 1, 29, 57 ]
  • Plasma PK parameters of GSK679586: Systemic clearance of parent drug (CL) [ Time Frame: Day 1, 29 and 57 ]
  • "Plasma PK parameters of GSK679586: volume of distribution (V)" [ Time Frame: Day 1, 29, 57 ]
  • 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 ]
  • 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 ]
  • 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 ]
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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Asthma
  • Drug: INTRAVENOUS GSK679586
    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
  • Drug: INTRAVENOUS PLACEBO
    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
  • Drug: FLUTICASONE PROPIONATE
    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.
  • Experimental: GSK679586
    Subjects will receive three, once monthly intravenous administration of 10 mg/kg of GSK679586, according to randomization
    Interventions:
    • Drug: INTRAVENOUS GSK679586
    • Drug: FLUTICASONE PROPIONATE
  • Placebo Comparator: PLACEBO
    Subjects will receive three, once monthly intravenous administration of saline, according to randomization
    Interventions:
    • Drug: INTRAVENOUS PLACEBO
    • Drug: FLUTICASONE PROPIONATE
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
190
July 25, 2010
July 25, 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

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Netherlands,   Norway,   Poland,   South Africa,   United Kingdom,   United States
 
 
NCT00843193
106870
No
Not Provided
Yes
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2017

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