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

October 26, 2016 updated by: GlaxoSmithKline

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: after 14 day repeat doses
after 14 day repeat doses

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in trough FEV1
Time Frame: after a single dose
after a single dose
Mean change from baseline in trough FEV1
Time Frame: after 7 days repeat dosing
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
Day 1 and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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