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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
B2C104604
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse events
Timepoint [1] 0 0
throughout study
Primary outcome [2] 0 0
Laboratory safety tests
Timepoint [2] 0 0
throughout study
Primary outcome [3] 0 0
Holter monitoring
Timepoint [3] 0 0
throughout study
Primary outcome [4] 0 0
Vital signs and 12-lead ECG)
Timepoint [4] 0 0
throughout study
Primary outcome [5] 0 0
Mean change from baseline FEV1 24 hours after dosing.
Timepoint [5] 0 0
Day 1, on 5 separate occasions
Primary outcome [6] 0 0
Supine systolic and diastolic blood pressure and supine heart rate
Timepoint [6] 0 0
Day 1 on 5 separate occasions
Primary outcome [7] 0 0
QTc(B)and QTc(F)
Timepoint [7] 0 0
Day 1 on 5 separate occasions
Secondary outcome [1] 0 0
Potassium Max decrease from baseline
Timepoint [1] 0 0
Day 1 on 5 separate occasions
Secondary outcome [2] 0 0
Mean change from baseline(0-4h)potassium.
Timepoint [2] 0 0
Day 1 on 5 separate occasions
Secondary outcome [3] 0 0
Glucose Max increase from baseline
Timepoint [3] 0 0
Day 1 on 5 separate occasions
Secondary outcome [4] 0 0
Weighted mean change from baseline (0-4h)glucose
Timepoint [4] 0 0
Day 1 on 5 separate occasions
Secondary outcome [5] 0 0
Derived PK parameters: Cmax, Tmax, AUC(0-t), AUC(0-inf),PEFR
Timepoint [5] 0 0
Day 1 on 5 separate occasions

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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
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
1/08/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2007
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

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

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00381667
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00381667