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

Condition Intervention Phase
Asthma Drug: INTRAVENOUS GSK679586 Drug: INTRAVENOUS PLACEBO Drug: FLUTICASONE PROPIONATE Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in Asthma Control Questionnaire (ACQ-7) over 12 weeks [ Time Frame: Throughout the study ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 190
Actual Study Start Date: December 9, 2008
Study Completion Date: July 25, 2010
Primary Completion Date: July 25, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK679586
Subjects will receive three, once monthly intravenous administration of 10 mg/kg of GSK679586, according to randomization
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: 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.
Placebo Comparator: PLACEBO
Subjects will receive three, once monthly intravenous administration of saline, according to randomization
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.

Detailed Description:
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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843193

  Show 35 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 106870
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 106870
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 106870
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 106870
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 106870
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 106870
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 106870
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00843193     History of Changes
Other Study ID Numbers: 106870
Study First Received: February 5, 2009
Last Updated: April 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Asthma
Asthma control questionnaire

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 21, 2017