A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In Asthmatic Patients

August 3, 2017 updated by: GlaxoSmithKline

A Randomized, Single-dose, Dose-ascending, Double Blind, Placebo-controlled, 5-way Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M With Magnesium Stearate in Asthmatic Patients

This study will involve the use of a new compound, GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. When a medicine is made into a form ready to be given to patients, the active ingredient is often prepared with another ingredient called a salt to help make it stable, and inactive ingredients are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In previous studies the study drug has been given as a dry powder containing either the "H" salt (with the inactive ingredient lactose), or containing the "M" salt (with the inactive ingredients lactose and cellobiose octaacetate). The "M" salt form of the study drug has been altered to contain lactose and a new inactive ingredient called magnesium stearate (instead of cellobiose octaacetate).

Participants in this study will receive both the "H" salt (GW642444H) and the new "M" salt (GW642444M) containing magnesium stearate. This study will be the first time the new "M" salt form of the study drug will be given to asthmatic patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

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

  • United Kingdom
      • London, United Kingdom, SE1 1YR
        • GSK Investigational Site
      • Manchester, United Kingdom, M23 9QZ
        • GSK Investigational Site
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • 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

All

Description

Inclusion criteria:

  • male or female (of non-childbearing potential) between 18 - 70 years
  • History of stable mild to moderate asthma
  • non - smokers
  • currently taking daily doses of inhaled fluticasone propionate 200 - 500 mcg (or equivalent)
  • body weight >50 kg with BMI 19-29.9 kg/m2
  • normal ECG assessment

Exclusion criteria:

  • history of significant disease
  • history of life threatening asthma
  • recent respiratory tract infection
  • recent change of asthma medication
  • treatment with high dose inhaled corticosteroids or oral corticosteroids
  • recent participation in another trial
  • history of drug or alcohol abuse
  • known allergies (excluding asthma)
  • recent blood donation

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
Experimental: GW642444M 25mcg
Subject will inhale single dose of GW642444M 25 mcg via a DISKUS device in morning.
Drug: GW642444M (25, 100 & 400 mcg)
M salt
Other Names:
  • placebo
  • GW642444M (25
  • 100 & 400 mcg)
  • GW642444H (100mcg)
Experimental: GW642444M 100mcg
Subject will inhale single dose of GW642444M 100 mcg via a DISKUS device in morning.
Drug: GW642444M (25, 100 & 400 mcg)
M salt
Other Names:
  • placebo
  • GW642444M (25
  • 100 & 400 mcg)
  • GW642444H (100mcg)
Experimental: GW642444M 400mcg
Subject will inhale single dose of GW642444M 400 mcg via a DISKUS device in morning.
Drug: GW642444M (25, 100 & 400 mcg)
M salt
Other Names:
  • placebo
  • GW642444M (25
  • 100 & 400 mcg)
  • GW642444H (100mcg)
Experimental: GW642444H 100mcg
Subject will inhale single dose of GW642444H 100 mcg via a DISKUS device in morning.
Drug: GW642444H (100mcg)
H salt
Placebo Comparator: placebo
Subject will inhale single dose of Placebo via a DISKUS device in morning.
Drug: placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
General safety and tolerability of the new formulation of GW642444 as measured by ECG, blood pressure, pulse rate and blood and urine tests. Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).
Time Frame: Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).
Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).

Secondary Outcome Measures

Outcome Measure
Time Frame
Airways relaxation assessed by lung function tests. Effect of study medicine on the body and amount of medicine in the body measured by potassium, glucose and medicine in blood samples. Measurements made over 24 hours on 5 occasions (1-2 weeks apart).
Time Frame: Measurements made over 24 hours on 5 occasions (1-2 weeks apart).
Measurements made over 24 hours on 5 occasions (1-2 weeks apart).

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.

General Publications

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 (Actual)

April 2, 2007

Primary Completion (Actual)

August 4, 2007

Study Completion (Actual)

August 4, 2007

Study Registration Dates

First Submitted

April 18, 2007

First Submitted That Met QC Criteria

April 18, 2007

First Posted (Estimate)

April 20, 2007

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2C106996

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. Dataset Specification
    Information identifier: B2C106996
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: B2C106996
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistical Analysis Plan
    Information identifier: B2C106996
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Study Protocol
    Information identifier: B2C106996
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: B2C106996
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: B2C106996
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: B2C106996
    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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