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Completed

NCT Number: NCT00463697

A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Harrow, Middlesex, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GW642444H (100mcg)

Drug

H salt

Placebo

Drug

placebo

GW642444M (25, 100 & 400 mcg)

Drug

M salt

Other names: placebo, GW642444M (25, 100 & 400 mcg), GW642444H (100mcg)

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 20, 2007
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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