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

NCT00463697 | Completed Phase 1

• 1 other identifier: B2C106996
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

GW642444,; magnesium stearate,; asthmatic patients

Outcome Measures

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).

  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).

  Measurements made over 24 hours on 5 occasions (1-2 weeks apart).

Study Arms (5)

GW642444M 25mcg

EXPERIMENTAL

Subject will inhale single dose of GW642444M 25 mcg via a DISKUS device in morning.

Drug: GW642444M (25, 100 & 400 mcg)

GW642444M 100mcg

EXPERIMENTAL

Subject will inhale single dose of GW642444M 100 mcg via a DISKUS device in morning.

Drug: GW642444M (25, 100 & 400 mcg)

GW642444M 400mcg

EXPERIMENTAL

Subject will inhale single dose of GW642444M 400 mcg via a DISKUS device in morning.

Drug: GW642444M (25, 100 & 400 mcg)

GW642444H 100mcg

EXPERIMENTAL

Subject will inhale single dose of GW642444H 100 mcg via a DISKUS device in morning.

Drug: GW642444H (100mcg)

placebo

PLACEBO COMPARATOR

Subject will inhale single dose of Placebo via a DISKUS device in morning.

Drug: placebo

Interventions

GW642444H (100mcg) DRUG

H salt

GW642444H 100mcg

placebo DRUG

placebo

placebo

GW642444M (25, 100 & 400 mcg) DRUG

M salt

Also known as: placebo, GW642444M (25, 100 & 400 mcg), GW642444H (100mcg)

GW642444M 100mcg; GW642444M 25mcg; GW642444M 400mcg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

GSK Investigational Site

London, SE1 1YR, United Kingdom

Location

GSK Investigational Site

Manchester, M23 9QZ, United Kingdom

Location

Related 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.

  PMID: 23232038 BACKGROUND

Related Links

• Results for study B2C106996 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 20, 2007
• Study Start: April 2, 2007
• Primary Completion: August 4, 2007
• Study Completion: August 4, 2007
• Last Updated: August 7, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (3)