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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463697
• Other study ID #: B2C106996
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2007
• Last updated: August 3, 2017
• Start date: April 2, 2007
• Est. completion date: August 4, 2007

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 4, 2007
• Est. primary completion date: August 4, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• GW642444H (100mcg)
H salt
• placebo
placebo
• GW642444M (25, 100 & 400 mcg)
M salt

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Harrow	Middlesex
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).
Secondary	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).		Measurements made over 24 hours on 5 occasions (1-2 weeks apart).

External 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.
•   Results for study B2C106996 can be found on the GSK Clinical Study Register.