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Study to Assess GW642444 in Asthma Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00381667
First received: September 26, 2006
Last updated: May 31, 2012
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Asthma
 Drug: GW642444M
Drug: GW642444H
Other: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Adverse events [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Laboratory safety tests [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Holter monitoring [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Vital signs and 12-lead ECG) [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • Mean change from baseline FEV1 24 hours after dosing. [ Time Frame: Day 1, on 5 separate occasions ] [ Designated as safety issue: No ]
  • Supine systolic and diastolic blood pressure and supine heart rate [ Time Frame: Day 1 on 5 separate occasions ] [ Designated as safety issue: No ]
  • QTc(B)and QTc(F) [ Time Frame: Day 1 on 5 separate occasions ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Potassium Max decrease from baseline [ Time Frame: Day 1 on 5 separate occasions ] [ Designated as safety issue: No ]
  • Mean change from baseline(0-4h)potassium. [ Time Frame: Day 1 on 5 separate occasions ] [ Designated as safety issue: No ]
  • Glucose Max increase from baseline [ Time Frame: Day 1 on 5 separate occasions ] [ Designated as safety issue: No ]
  • Weighted mean change from baseline (0-4h)glucose [ Time Frame: Day 1 on 5 separate occasions ] [ Designated as safety issue: No ]
  • Derived PK parameters: Cmax, Tmax, AUC(0-t), AUC(0-inf),PEFR [ Time Frame: Day 1 on 5 separate occasions ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: August 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GW642444M 12.5 Drug: GW642444M
M salt
Other Name: GW642444
Experimental: GW642444M 100mcg Drug: GW642444M
M salt
Other Name: GW642444
Experimental: GW642444M 400mcg Drug: GW642444M
M salt
Other Name: GW642444
Experimental: GW642444H 100mcg Drug: GW642444H
H salt
Experimental: Placebo Other: placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381667

Locations
Australia, Victoria
GSK Investigational Site
Clayton, Victoria, Australia, 3168
New Zealand
GSK Investigational Site
Wellington, New Zealand, 6001
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00381667     History of Changes
Other Study ID Numbers: B2C104604
Study First Received: September 26, 2006
Last Updated: May 31, 2012
Health Authority: New Zealand: Medsafe
New Zealand: Health and Disability Ethics Committees
New Zealand: Medicines and Medical Devices Safety Authority

Keywords provided by GlaxoSmithKline:
safety
GW642444M
Single Dose
pharmacodynamics
 pharmacokinetics
GW642444H
tolerability

Additional relevant MeSH terms:
Asthma
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
 Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013