Study to Assess GW642444 in Asthma Patients

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, Dose Ascending, Five-way Crossover Study, to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of a Single Administration of Three Inhaled Doses (25, 100 and 400 µg) of GW642444M

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381667
• Other study ID #: B2C104604
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2006
• Last updated: October 26, 2016
• Start date: August 2006
• Est. completion date: January 2007

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study of GW642444M, a long-acting beta 2 specific agonist. This study will examine GW642444M via the inhaled route and will assess the efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of a single administration of three inhaled doses (25, 100 and 400 µg) of GW642444M in persistent asthmatics. This study will be a single-centre, placebo-controlled, dose-ascending, five-way crossover in 30 asthmatic patients.

Key assessments: efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics will be assessed by measurement of FEV1, blood pressure, pulse rate, 12-lead ECGs, clinical laboratory safety tests, collection of adverse events and blood samples.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

• Subjects with a documented history of persistent asthma, with the exclusion of other significant pulmonary diseases

• Female subjects of non-child bearing potential (i.e. post-menopausal or surgically sterile)

• Subjects who are current non-smokers, who have not used any inhaled tobacco products (snuff is permitted) in the 12 month period preceding the screening visit and who have a pack history of less than 10 pack years.

• Subjects with clinically stable persistent asthma within the 4 weeks preceding the screening visit and with a screening pre-bronchodilator FEV1 between 60 and 90% predicted (having abstained from bronchodilators for the required period). Predicted values are based on the ECCS 1993 normal ranges

• During the screening visit, subjects must demonstrate the presence of reversible airway disease, defined as an increase in FEV1 of greater than 12.0% over baseline and an absolute change of greater than 300 mL within 30 minutes following a single 400 mcg salbutamol dose.

• Subjects who are currently taking ICS at a total daily dose of 200 to 500 mcg of FP or equivalent ICS

Exclusion criteria:

• Subjects who have a past or present disease, which as judged by the Investigator and the Medical Monitor, which may affect the safety of the subject or outcome of this study

• A screening Holter ECG tracing that reveals clinically concerning arrhythmias (including, but not limited to, ventricular ectopic runs of 4 beats, R on T phenomena, bigeminy, trigeminy).

• A mean QTc(B) value at screening >430 msec (male) / >450 msec (female) or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave).

• Any adverse reaction including immediate or delayed hypersensitivity to any ß2 agonist or sympathomimetic drug, or known or suspected sensitivity to the constituents of GW642444 inhalation powder (e.g., lactose or COA).

• Subjects weighing < 50 kg

• Subjects who have participated in any GSK study involving administration of COA.

Related Conditions & MeSH terms

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

Intervention

Drug:
• GW642444M
M salt
• GW642444H
H salt

Other:
• placebo
placebo

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Clayton	Victoria
New Zealand	GSK Investigational Site	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		throughout study
Primary	Laboratory safety tests		throughout study
Primary	Holter monitoring		throughout study
Primary	Vital signs and 12-lead ECG)		throughout study
Primary	Mean change from baseline FEV1 24 hours after dosing.		Day 1, on 5 separate occasions
Primary	Supine systolic and diastolic blood pressure and supine heart rate		Day 1 on 5 separate occasions
Primary	QTc(B)and QTc(F)		Day 1 on 5 separate occasions
Secondary	Potassium Max decrease from baseline		Day 1 on 5 separate occasions
Secondary	Mean change from baseline(0-4h)potassium.		Day 1 on 5 separate occasions
Secondary	Glucose Max increase from baseline		Day 1 on 5 separate occasions
Secondary	Weighted mean change from baseline (0-4h)glucose		Day 1 on 5 separate occasions
Secondary	Derived PK parameters: Cmax, Tmax, AUC(0-t), AUC(0-inf),PEFR		Day 1 on 5 separate occasions

External Links

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