Study to Assess GW642444 in Asthma Patients

NCT00381667 | Completed Phase 2

• 1 other identifier: B2C104604
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

safety; GW642444M; Single Dose; pharmacodynamics; pharmacokinetics; GW642444H; tolerability

Outcome Measures

Primary Outcomes (7)

• Adverse events

  throughout study

• Laboratory safety tests

  throughout study

• Holter monitoring

  throughout study

• Vital signs and 12-lead ECG)

  throughout study

• Mean change from baseline FEV1 24 hours after dosing.

  Day 1, on 5 separate occasions

• Supine systolic and diastolic blood pressure and supine heart rate

  Day 1 on 5 separate occasions

• QTc(B)and QTc(F)

  Day 1 on 5 separate occasions

Secondary Outcomes (5)

• Potassium Max decrease from baseline

  Day 1 on 5 separate occasions

• Mean change from baseline(0-4h)potassium.

  Day 1 on 5 separate occasions

• Glucose Max increase from baseline

  Day 1 on 5 separate occasions

• Weighted mean change from baseline (0-4h)glucose

  Day 1 on 5 separate occasions

• Derived PK parameters: Cmax, Tmax, AUC(0-t), AUC(0-inf),PEFR

  Day 1 on 5 separate occasions

Study Arms (5)

GW642444M 12.5

EXPERIMENTAL

Drug: GW642444M

GW642444M 100mcg

EXPERIMENTAL

Drug: GW642444M

GW642444M 400mcg

EXPERIMENTAL

Drug: GW642444M

GW642444H 100mcg

EXPERIMENTAL

Drug: GW642444H

Placebo

EXPERIMENTAL

Other: placebo

Interventions

GW642444M DRUG

M salt

Also known as: GW642444

GW642444M 100mcg; GW642444M 12.5; GW642444M 400mcg

GW642444H DRUG

H salt

GW642444H 100mcg

placebo OTHER

placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Clayton, Victoria, 3168, Australia

Location

GSK Investigational Site

Wellington, 6001, New Zealand

Location

Related 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.

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 28, 2006
• Study Start: August 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: October 28, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

AU (1); NZ (1)