Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00358488
First received: July 27, 2006
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: GSK159797 (10, 15, and 20mcg)
Drug: salbutamol
Drug: salmeterol 50mcg
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-enter, Randomized, Double-blind, Placebo-controlled, Four-way Incomplete Block Crossover Study to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (10, 15, and 20 Mcg) of GSK159797

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean change from baseline in trough FEV1 [ Time Frame: after 14 day repeat doses ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline in trough FEV1 [ Time Frame: after a single dose ] [ Designated as safety issue: No ]
  • Mean change from baseline in trough FEV1 [ Time Frame: after 7 days repeat dosing ] [ Designated as safety issue: No ]
  • Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours [ Time Frame: Day 1 and Day 14 ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: April 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK159797 (10, 15, and 20mcg)
GSK159797 (10, 15, and 20mcg)
Drug: GSK159797 (10, 15, and 20mcg)
GSK159797 (10, 15, and 20mcg)
Experimental: salbutamol
salbutamol
Drug: salbutamol
salbutamol
Experimental: salmeterol 50mcg
salmeterol 50mcg
Drug: salmeterol 50mcg
salmeterol 50mcg
Placebo Comparator: placebo
placebo
Drug: placebo
placebo
Other Names:
  • GSK159797 (10
  • 15
  • and 20mcg)
  • salbutamol
  • salmeterol 50mcg
  • placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
  • Female subjects only using acceptable birth control method
  • Non-smokers
  • FEV1 between 60 and 90% predicted
  • Increase in FEV1 12% or greater and 300mL and greater after salbutamol use

Exclusion criteria:

  • Past or present disease conditions
  • Normal screening Holter ECG
  • Respiratory tract infection within 4 weeks of screening
  • History of life threatening asthma
  • Previous use of COA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358488

Locations
Germany
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65187
GSK Investigational Site
Berlin, Germany, 14057
Netherlands
GSK Investigational Site
Utrecht, Netherlands, 3584 CJ
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 115446
Sweden
GSK Investigational Site
Lund, Sweden, SE-221 85
United Kingdom
GSK Investigational Site
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00358488     History of Changes
Other Study ID Numbers: B2E106359
Study First Received: July 27, 2006
Last Updated: November 7, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:
Safety
Asthmatic patients
GSK159797
Efficacy

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Albuterol
Salmeterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 14, 2014