Clinical trial NCT00463697: A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In Asthmatic Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: GW642444,
magnesium stearate,
asthmatic patients
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).
Secondary outcomes:
measure: 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).
timeFrame: Measurements made over 24 hours on 5 occasions (1-2 weeks apart).
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Kempsford R, Norris V, Siederer S. Vilanterol trifenatate, a novel inhaled long-acting beta2 adrenoceptor agonist, is well tolerated in healthy subjects and demonstrates prolonged bronchodilation in subjects with asthma and COPD. Pulm Pharmacol Ther. 2013 Apr;26(2):256-64. doi: 10.1016/j.pupt.2012.12.001. Epub 2012 Dec 8.