Clinical trial NCT00843193: Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Asthma control questionnaire
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-02-13
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study

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

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Asthma Control Questionnaire (ACQ-7) Over 12 Weeks
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change From Baseline in ACQ-7 Over 16 Weeks and 24 Weeks
timeFrame: Week 16 and Week 24
measure: Number of Participants Who Demonstrated a Clinically Meaningful Change in ACQ-7 Over the 12 Weeks Assessment Period.
timeFrame: Upto 12 weeks
measure: Change From Baseline in Forced Expiratory Volume (FEV1) Over 12 Weeks.
timeFrame: Baseline to Week 12
measure: Change From Baseline in FEV1 Over 16 Weeks and 24 Weeks
timeFrame: Week 16 and 24
measure: Percentage of Participants Who Demonstrated a Clinically Meaningful Increase in FEV1 Over the 12 Week Assessment Period
timeFrame: Upto 12 weeks
measure: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to Week 25
measure: Number of Participants With Abnormal Vital Signs of Potential Clinical Importance: Systolic and Distolic Blood Pressure and Heart Rate.
timeFrame: Screening, Day -28, 1, 15, 29, 50, 57 and 169 (follow-up 3)
measure: Number of Participants With Clinically Significant Abnormality in 12-lead Electrocardiogram (ECG)
timeFrame: Upto Week 25
measure: Number of Participants With Abnormal Hematological Parameters of Potential Clinical Importance
timeFrame: Upto Week 25
measure: Number of Participants With Abnormal Clinical Chemistry Parameters of Potential Clinical Importance
timeFrame: Upto Week 25
measure: Number of Participants With Abnormal Urinanalysis Parameters of Potential Clinical Importance
timeFrame: Upto Week 25
measure: Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve Over the Dosing Interval (AUC (0-τ)).
timeFrame: Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.
measure: PK Parameter:Maximum Observed Concentration (Cmax)
timeFrame: Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.
measure: PK Parameter: Systemic Clearance of Parent Drug
timeFrame: Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.
measure: PK Parameter: Volume of Distribution
timeFrame: Day 1 (Pre-dose, 0.25h, 1.00h), Day 4 (72h), Day 29 (672 h), Day 57 (1344h), Day 61 (1440h), Day 85 (2016h), Day 141 (3360h), Day 169 (4032h) and Follow up visits.
measure: Number of Participants With Confirmed Positive Anti-GSK679586 Antibody Results After Initiation of Study Treatment
timeFrame: Up to Week 25
Other outcomes:
Locations:
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Pittsburg
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Orangeburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Boerne
country: United States
facility: GSK Investigational Site
state: Texas
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Lille
country: France
facility: GSK Investigational Site
city: Marseille
country: France
facility: GSK Investigational Site
city: Montpellier
country: France
facility: GSK Investigational Site
city: Nantes
country: France
facility: GSK Investigational Site
city: Saint Pierre Cedex
country: France
facility: GSK Investigational Site
city: Strasbourg
country: France
facility: GSK Investigational Site
city: Tarbes Cedex 09
country: France
facility: GSK Investigational Site
city: Frankfurt
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Gelnhausen
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Eindhoven
country: Netherlands
facility: GSK Investigational Site
city: Heerlen
country: Netherlands
facility: GSK Investigational Site
city: Hoorn
country: Netherlands
facility: GSK Investigational Site
city: Elverum
country: Norway
facility: GSK Investigational Site
city: Trondheim
country: Norway
facility: GSK Investigational Site
city: Bialystok
country: Poland
facility: GSK Investigational Site
city: Gidle
country: Poland
facility: GSK Investigational Site
city: Krakow
country: Poland
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Bellville
country: South Africa
facility: GSK Investigational Site
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
city: Mowbray
country: South Africa
facility: GSK Investigational Site
city: Southampton
country: United Kingdom
facility: GSK Investigational Site
state: Hampshire
city: Guildford
country: United Kingdom
facility: GSK Investigational Site
state: Surrey
city: Belfast
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.