Phase 2 N=198 Randomized Quadruple-blind Treatment

Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma

Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00843193 ↗

Enrolled (actual)

198

Serious AEs

6.6%

Results posted

Dec 2017

Primary outcome: Primary: Change From Baseline in Asthma Control Questionnaire (ACQ-7) Over 12 Weeks — -0.1; -0.2; -0.1; -0.3 Scores on Scale — p=0.1955

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: INTRAVENOUS GSK679586 (Drug); INTRAVENOUS PLACEBO (Drug); FLUTICASONE PROPIONATE (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Asthma Control Questionnaire (ACQ-7) Over 12 Weeks	-0.1; -0.2; -0.1; -0.3; -0.2; -0.3	0.1955
SECONDARY Change From Baseline in ACQ-7 Over 16 Weeks and 24 Weeks	-0.3; -0.4; -0.3; -0.2	—
SECONDARY Number of Participants Who Demonstrated a Clinically Meaningful Change in ACQ-7 Over the 12 Weeks Assessment Period.	16; 20; 22; 29; 31; 26	—
SECONDARY Change From Baseline in Forced Expiratory Volume (FEV1) Over 12 Weeks.	0.009; 0.002; 0.033; 0.037; 0.035; -0.009	0.7693
SECONDARY Change From Baseline in FEV1 Over 16 Weeks and 24 Weeks	0.109; 0.010; 0.065; -0.021	—
SECONDARY Percentage of Participants Who Demonstrated a Clinically Meaningful Increase in FEV1 Over the 12 Week Assessment Period	16; 20; 22; 23; 25; 15	—
SECONDARY Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)	49; 52; 5; 8	—
SECONDARY Number of Participants With Abnormal Vital Signs of Potential Clinical Importance: Systolic and Distolic Blood Pressure and Heart Rate.	6; 6; 8; 4; 0; 1	—
SECONDARY Number of Participants With Clinically Significant Abnormality in 12-lead Electrocardiogram (ECG)	0; 1; 0; 1; 0; 2	—
SECONDARY Number of Participants With Abnormal Hematological Parameters of Potential Clinical Importance	5; 3; 3; 1; 3; 4	—
SECONDARY Number of Participants With Abnormal Clinical Chemistry Parameters of Potential Clinical Importance	14; 17; 10; 17; 4; 3	—
SECONDARY Number of Participants With Abnormal Urinanalysis Parameters of Potential Clinical Importance	0; 0	—
SECONDARY Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve Over the Dosing Interval (AUC (0-τ)).	64787259; 86256087; 93710588	—
SECONDARY PK Parameter:Maximum Observed Concentration (Cmax)	278610.6; 332528.4; 355177.0	—
SECONDARY PK Parameter: Systemic Clearance of Parent Drug	0.00010; 0.00010; 0.00010	—
SECONDARY PK Parameter: Volume of Distribution	0.0356; 0.0355; 0.0354; 0.0296; 0.0296; 0.0296	—
SECONDARY Number of Participants With Confirmed Positive Anti-GSK679586 Antibody Results After Initiation of Study Treatment	4; 2	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00843193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.