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

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: placebo; Drug: GSK159797 (10, 15, and 20mcg); Drug: salbutamol; Drug: salmeterol 50mcg

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14057
    • GSK Investigational Site
  • Hessen
    • Wiesbaden, Hessen, Germany, 65187
      • GSK Investigational Site
• Netherlands
  • Utrecht, Netherlands, 3584 CJ
    • GSK Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 115446
    • GSK Investigational Site
• Sweden
  • Lund, Sweden, SE-221 85
    • GSK Investigational Site
• United Kingdom
  • Manchester, United Kingdom, M23 9LT
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; placebo; Other Names: salbutamol; GSK159797 (10; 15; and 20mcg); salmeterol 50mcg
Experimental: GSK159797 (10, 15, and 20mcg)	Drug: GSK159797 (10, 15, and 20mcg); GSK159797 (10, 15, and 20mcg)
Experimental: salbutamol	Drug: salbutamol; salbutamol
Experimental: salmeterol 50mcg	Drug: salmeterol 50mcg; salmeterol 50mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in trough FEV1	after 14 day repeat doses

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: July 27, 2006
• First Submitted That Met QC Criteria: July 27, 2006
• First Posted (Estimate): July 31, 2006

Study Record Updates

• Last Update Posted (Estimate): October 28, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Asthmatic patients; GSK159797
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol; Salmeterol Xinafoate
• Other Study ID Numbers: B2E106359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.

Study Data/Documents

1. Study Protocol
   Information identifier: B2E106359
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Informed Consent Form
   Information identifier: B2E106359
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Clinical Study Report
   Information identifier: B2E106359
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: B2E106359
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: B2E106359
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Annotated Case Report Form
   Information identifier: B2E106359
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Individual Participant Data Set
   Information identifier: B2E106359
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register