Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00843193
• Date of registration: 05/02/2009
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma
• Scientific 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
• Date of first enrolment: December 9, 2008
• Target sample size: 198
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00843193
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

France, Germany, Netherlands, Norway, Poland, South Africa, United Kingdom, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: INTRAVENOUS GSK679586

Drug: INTRAVENOUS PLACEBO

Drug: FLUTICASONE PROPIONATE

Primary Outcome(s)

Change From Baseline in Asthma Control Questionnaire (ACQ-7) Over 12 Weeks [Time Frame: Baseline to Week 12]

Secondary Outcome(s)

Number of Participants Who Demonstrated a Clinically Meaningful Change in ACQ-7 Over the 12 Weeks Assessment Period. [Time Frame: Upto 12 weeks]

Number of Participants With Abnormal Vital Signs of Potential Clinical Importance: Systolic and Distolic Blood Pressure and Heart Rate. [Time Frame: Screening, Day -28, 1, 15, 29, 50, 57 and 169 (follow-up 3)]

PK Parameter:Maximum Observed Concentration (Cmax) [Time Frame: 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.]

Change From Baseline in FEV1 Over 16 Weeks and 24 Weeks [Time Frame: Week 16 and 24]

Number of Participants With Abnormal Urinanalysis Parameters of Potential Clinical Importance [Time Frame: Upto Week 25]

Percentage of Participants Who Demonstrated a Clinically Meaningful Increase in FEV1 Over the 12 Week Assessment Period [Time Frame: Upto 12 weeks]

Number of Participants With Clinically Significant Abnormality in 12-lead Electrocardiogram (ECG) [Time Frame: Upto Week 25]

Number of Participants With Confirmed Positive Anti-GSK679586 Antibody Results After Initiation of Study Treatment [Time Frame: Up to Week 25]

PK Parameter: Volume of Distribution [Time Frame: 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.]

PK Parameter: Systemic Clearance of Parent Drug [Time Frame: 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.]

Number of Participants With Abnormal Clinical Chemistry Parameters of Potential Clinical Importance [Time Frame: Upto Week 25]

Change From Baseline in ACQ-7 Over 16 Weeks and 24 Weeks [Time Frame: Week 16 and Week 24]

Number of Participants With Abnormal Hematological Parameters of Potential Clinical Importance [Time Frame: Upto Week 25]

Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Up to Week 25]

Change From Baseline in Forced Expiratory Volume (FEV1) Over 12 Weeks. [Time Frame: Baseline to Week 12]

Pharmacokinetic (PK) Parameter: Area Under the Concentration-time Curve Over the Dosing Interval (AUC (0-t)). [Time Frame: 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.]

Secondary ID(s)

106870

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/12/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00843193