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
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
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014