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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: October 26, 2016
Last verified: October 2016
  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
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 ]

Secondary Outcome Measures:
  • Mean change from baseline in trough FEV1 [ Time Frame: after a single dose ]
  • Mean change from baseline in trough FEV1 [ Time Frame: after 7 days repeat dosing ]
  • Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours [ Time Frame: Day 1 and Day 14 ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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
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: 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

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: B2E106359
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: B2E106359
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: B2E106359
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: B2E106359
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: B2E106359
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: B2E106359
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: B2E106359
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00358488     History of Changes
Other Study ID Numbers: B2E106359 
Study First Received: July 27, 2006
Last Updated: October 26, 2016
Individual Participant Data  
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:
Safety
Asthmatic patients
GSK159797
Efficacy

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

ClinicalTrials.gov processed this record on February 17, 2017