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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00381667
Registration number
NCT00381667
Ethics application status
Date submitted
26/09/2006
Date registered
28/09/2006
Date last updated
28/10/2016
Titles & IDs
Public title
Study to Assess GW642444 in Asthma Patients
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Scientific 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
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Secondary ID [1]
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B2C104604
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GW642444M
Treatment: Drugs - GW642444H
Other interventions - placebo
Experimental: GW642444M 12.5 -
Experimental: GW642444M 100mcg -
Experimental: GW642444M 400mcg -
Experimental: GW642444H 100mcg -
Experimental: Placebo -
Treatment: Drugs: GW642444M
M salt
Treatment: Drugs: GW642444H
H salt
Other interventions: placebo
placebo
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adverse events
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Assessment method [1]
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Timepoint [1]
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throughout study
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Primary outcome [2]
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Laboratory safety tests
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Assessment method [2]
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Timepoint [2]
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throughout study
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Primary outcome [3]
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Holter monitoring
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Assessment method [3]
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Timepoint [3]
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throughout study
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Primary outcome [4]
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Vital signs and 12-lead ECG)
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Assessment method [4]
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Timepoint [4]
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throughout study
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Primary outcome [5]
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Mean change from baseline FEV1 24 hours after dosing.
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Assessment method [5]
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Timepoint [5]
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Day 1, on 5 separate occasions
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Primary outcome [6]
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Supine systolic and diastolic blood pressure and supine heart rate
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Assessment method [6]
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Timepoint [6]
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Day 1 on 5 separate occasions
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Primary outcome [7]
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QTc(B)and QTc(F)
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Assessment method [7]
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Timepoint [7]
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Day 1 on 5 separate occasions
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Secondary outcome [1]
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Potassium Max decrease from baseline
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Assessment method [1]
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Timepoint [1]
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Day 1 on 5 separate occasions
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Secondary outcome [2]
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Mean change from baseline(0-4h)potassium.
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Assessment method [2]
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Timepoint [2]
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Day 1 on 5 separate occasions
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Secondary outcome [3]
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Glucose Max increase from baseline
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Assessment method [3]
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Timepoint [3]
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Day 1 on 5 separate occasions
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Secondary outcome [4]
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Weighted mean change from baseline (0-4h)glucose
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Assessment method [4]
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Timepoint [4]
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Day 1 on 5 separate occasions
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Secondary outcome [5]
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Derived PK parameters: Cmax, Tmax, AUC(0-t), AUC(0-inf),PEFR
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Assessment method [5]
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Timepoint [5]
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Day 1 on 5 separate occasions
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Eligibility
Key inclusion 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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2007
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Sample size
Target
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Accrual to date
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Final
14
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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GSK Investigational Site - Clayton
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Wellington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00381667
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00381667
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