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: September 19, 2013
Last verified: February 2012
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Active GSK679586
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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: Throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of GSK679586 on the changes from baseline in FEV1 and ACQ-7, safety and tolerability, PK and immunogenicity [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Enrollment: 160
Study Start Date: December 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active GSK679586
Drug: GSK679586
Drug: Active GSK679586
Drug: GSK679586
Drug: Placebo
Placebo treatment
Placebo Comparator: Placebo
Placebo: saline
Drug: Active GSK679586
Drug: GSK679586
Drug: Placebo
Placebo treatment

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
Genders Eligible for Study:   Both
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:
No publications provided by GlaxoSmithKline

Additional 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: September 19, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Norway: Statens Legemiddelverk
South Africa: Medicines Control Council
Poland: URZ.D REJESTRACJI PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH,CEBK
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Germany: Paul-Ehrlich-Institut
United States: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:
Asthma
Asthma control questionnaire

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014