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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00625196




Registration number
NCT00625196
Ethics application status
Date submitted
19/02/2008
Date registered
28/02/2008

Titles & IDs
Public title
Comparing Two Respiratory Drugs in Combination and Separately From a Novel Inhaler Device in Healthy Japanese Subjects
Scientific title
A Randomised, Double-blind, Placebo-controlled, Four-way Crossover Study to Compare the Pharmacodynamics and Pharmacokinetics of GW685698X and GW642444M When Administered Separately and in Combination as a Single Dose From a Novel Dry Powder Device in Healthy Japanese Subjects
Secondary ID [1] 0 0
HZA102940
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fluticasone foroate/ vilanterol
Treatment: Drugs - Fluticasone foroate
Treatment: Drugs - Vilanterol
Treatment: Drugs - Placebo

Experimental: Subjects receiving fluticasone foroate/ vilanterol - Eligible subjects will receive single dose of fluticasone foroate/ vilanterol combination treatment 800 micrograms/ 50 micrograms administered using a novel powder inhaler. There will be a washout period of 7 to 10 days between treatments.

Active comparator: Subjects receiving fluticasone foroate - Eligible subjects will receive single dose of fluticasone foroate 800 micrograms administered using a novel powder inhaler.

Active comparator: Subjects receiving vilanterol - Eligible subjects will receive single dose of vilanterol 50 micrograms administered using a novel powder inhaler.

Placebo comparator: Subjects receiving placebo - Eligible subjects will receive single dose of placebo administered using a novel powder inhaler.


Treatment: Drugs: Fluticasone foroate/ vilanterol
Fluticasone foroate/ vilanterol 800 micrograms/ 50 micrograms will be available as dry powder inhaler.

Treatment: Drugs: Fluticasone foroate
Fluticasone foroate 800 micrograms will be available as dry powder inhaler.

Treatment: Drugs: Vilanterol
Vilanterol will be available as dry powder inhaler.

Treatment: Drugs: Placebo
Placebo will be supplied as dry powder inhaler.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum heart rate
Timepoint [1] 0 0
over 4 hours after dosing.
Primary outcome [2] 0 0
Blood pressure changes
Timepoint [2] 0 0
over 12 hours.
Primary outcome [3] 0 0
Electrocardiogram changes
Timepoint [3] 0 0
over 12 hours.
Primary outcome [4] 0 0
Change in peak expiry flow rate changes
Timepoint [4] 0 0
over 24 hours.
Primary outcome [5] 0 0
Change in serum cortisol concentration changes
Timepoint [5] 0 0
over 24 hours
Secondary outcome [1] 0 0
Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)
Timepoint [1] 0 0
over 48 hours after dosing.
Secondary outcome [2] 0 0
Change in blood potassium levels
Timepoint [2] 0 0
within 4 hours of drug dosing.
Secondary outcome [3] 0 0
Mean heart rate
Timepoint [3] 0 0
over 4 hours after dosing
Secondary outcome [4] 0 0
Plasma concentrations and derived pharmacokinetic parameters (AUC, Cmax,t½, tmax) for GW685698X, GW642444 and the GW642444 inactive metabolites GW630200 and GSK932009
Timepoint [4] 0 0
over 48 hours after dosing

Eligibility
Key inclusion criteria
Inclusion criteria:

* Healthy male adults aged between 20 and 60 years inclusive
* Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
* Male subjects must use double-barrier (condom/spermicide) birth control methods or abstain from sexual intercourse with female partners who are pregnant, lactating, or able to bear children in addition to any birth control method the female partner is using, from the first dose of study medication until 90 days after the last dose of study medication.
* Japanese ethnic origin (defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese)
* Body weight = 45 kg and body mass index within the range of 18-28 kg/m2 inclusive.
* No significant abnormality on 12-lead ECG at screening, including the following specific requirements:

* Ventricular rate = 45 beats per minute
* PR interval = 210msec
* Q waves < 30msec (up to 50 ms permitted in lead III only)
* QRS interval to be = 60msec and = 120msec
* The waveforms must enable the QT interval to be clearly defined
* QTc interval must be < 450msec (QTcB or QTcF; machine or manual reading) based on a single ECG value, or an average from three ECGs obtained over a brief recording period
* No significant abnormality on the Holter ECG at screening.
* FEV1 =90% predicted and FEV1 / FVC ratio = 0.7 at screening
* Subjects who are current non- smokers who have not used any tobacco products in the 12 month period preceding the screening visit and have a pack history of < 5 pack years
* Signed and dated informed consent is obtained for the subject
* Subjects who are able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions.
* Subjects who are able to use the inhalation device satisfactorily
Minimum age
20 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* As a result of medical interview, physical examination or screening investigations, the principle investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg unless the Investigator confirms that it is satisfactory for their age.
* The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
* Subjects who have suffered an upper or lower respiratory tract infection within 4 weeks of the screening visit.
* Liver function tests (AST, ALT or ALP) greater than 1.5 of the upper limit of laboratory reference range.
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
* History of milk protein allergy.
* The subject has taken prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is the longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sponsor the medication will not interfere with the study procedures or compromise subject safety.
* The subject has taken oral corticosteroids less than 8 weeks before the screening visit
* The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit
* History of alcohol/drug abuse or dependence within 12 months of the study
* Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a 285mL glass of full strength beer or 425mL schooner of light beer or 1 (30mL) measure of spirits or 1 glass (100mL) of wine
* The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* The subject has donated a unit (450mL) of blood within the previous 16 weeks or intends to donate within 16 weeks after completing the study.
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
* The subject has tested positive for HIV antibodies.
* The subject has a positive pre-study urine drug screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
* Positive CO or alcohol breath test at screening or on admission to the Unit.
* History of any adverse reaction including immediate or delayed hypersensitivity to any ICS, ß2 agonist or sympathomimetic drug.
* Any known or suspected sensitivity to the constituents of GW642444M or GW685698X inhalation powder (i.e., lactose, magnesium stearate).
* Subjects at risk of non-compliance.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/05/2008
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00625196