Clinical Trials Register

Summary
EudraCT Number:	2012-000741-12
Sponsor's Protocol Code Number:	HZA112776
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2012-03-08
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2012-000741-12

A.3

Full title of the trial

A Randomized, Double blind, Placebo controlled, Two-Way Crossover 7-day study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Dose Inhaled GW642444 25μg in Children aged 5-11 years with Persistent Asthma

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to see if it is safe to give a new asthma reliever drug (called vilanterol) to 5 to 11 year old children with asthma

A.3.2

Name or abbreviated title of the trial where available

Not Applicable

A.4.1

Sponsor's protocol code number

HZA112776

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/119/2011

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GlaxoSmithKline Research & Development Ltd
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	GlaxoSmithKline Research & Development Ltd
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GlaxoSmithKline
B.5.2	Functional name of contact point	GSK Clinical Support Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	GlaxoSmithKline, Iron Bridge Road, Stockley Park
B.5.3.2	Town/ city	Uxbridge, Middlesex
B.5.3.3	Post code	UB11 1BU
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+44 20 8990 4466
B.5.5	Fax number	+44208990 1234
B.5.6	E-mail	GSKClinicalSupportHD@gsk.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Vilanterol/GW642444
D.3.2	Product code	GW642444
D.3.4	Pharmaceutical form	Inhalation powder, pre-dispensed
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Vilanterol trifenatate
D.3.9.1	CAS number	503070-58-4
D.3.9.2	Current sponsor code	GW642444M (M suffix defines triphenylacetate salt)
D.3.9.3	Other descriptive name	Vilanterol trifenatate
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	25
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Inhalation powder, pre-dispensed
D.8.4	Route of administration of the placebo	Inhalation use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Asthma

E.1.1.1

Medical condition in easily understood language

Asthma: A medical condition where inflammation (redness and swelling) and constriction (tightening) of the airways is present in the lungs making it difficult to breath.

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	PT
E.1.2	Classification code	10003553
E.1.2	Term	Asthma
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the safety and tolerability following administration of GW642444 25
μg, via a novel dry powder inhaler, once-daily for 7 days in subjects aged 5–11
years.

E.2.2

Secondary objectives of the trial

• To characterise the pharmacokinetics of GW642444 25 μg, following administration
via a novel dry powder inhaler, once-daily for 7 days in subjects aged 5–11 years.
• To determine the effects of administration of GW642444 25 μg, via a novel dry powder inhaler, once-daily for 7 days on glucose and potassium in subjects aged 5–11 years.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male and pre-menarchial female subjects aged 5–11 years on the last planned
treatment day are eligible for this study. Pre-menarchial females are defined as
any female who has yet to begin menses and is considered Tanner Stage 2 or
less.
2. Diagnosis of asthma at least 6 months prior to screening.
3. Patients must be controlled on their existing asthma treatment at Screening as
defined by a Childhood Asthma Control Test score of >19 and PEF >75 %
predicted.
4. Subjects must be taking a stable regimen of fluticasone propionate (up to ≤200
μg twice daily; no more than 400 μg total daily dose) or an equivalent
corticosteroid and a short acting beta-agonist inhaler on an as-needed basis for at
least 4 weeks prior to screening.
5. Apart from asthma, eczema and rhinitis, subjects should be healthy and suffer
from no other significant medical conditions.
6. Subjects must weigh at least 15 kg.
7. Subjects must demonstrate ability to accept and effectively use the GW642444
device using the demonstration kits provided to the site.
8. The subject and parent or guardian are able to understand and comply with
protocol requirements, instructions, and protocol-stated restrictions. The parent
or guardian must have the ability to read, write and record diary information
collected throughout the study. The parent or guardian must also have the ability
to manage study drug administration and PEF assessments.
9. At least one parent or guardian has signed and dated the written informed
consent prior to admission to the study. This will be accompanied by informed
assent from the subject.

E.4

Principal exclusion criteria

1. Subjects currently receiving (or have received within 4 weeks of screening) any of
the following asthma therapies: theophyllines, long-acting inhaled beta-agonists, oral
beta-agonist.
2. Subjects who have changed their asthma medication within 4 weeks of screening.
3. Clinical visual evidence of oral candidiasis at screening.
4. Any clinically relevant abnormality identified on the screening medical assessment
5. Any medical condition or circumstance making the subject unsuitable for
participation in the study (e.g. history of life-threatening asthma)
6. Asthma exacerbation requiring systemic corticosteroids (oral, intramuscular,
intravenous) or Emergency Room attendance within 3 months or asthma
exacerbation requiring hospitalization within 6 months prior to the screening visit.
7. Culture-documented or suspected bacterial or viral infection of the upper or lower
respiratory tract which is not resolved within 4 weeks of the screening visit.
8. Any adverse reaction including immediate or delayed hypersensitivity to any betaagonist
therapy.
9. Known or suspected sensitivity to the constituents of the novel dry powder inhaler
(i.e., lactose or magnesium stearate), for example, history of severe milk protein
allergy.
10. The parent or guardian has history of psychiatric disease, intellectual deficiency,
substance abuse, or other condition (e.g., inability to read, comprehend or write)
which will limit the validity of consent to participate in this study.
11. A subject will not be eligible for this study if he/she is an immediate family member
of the participating Investigator, sub-Investigator, study coordinator, or employee of
the participating Investigator.
12. Children who are wards of the state or government.
13. Evidence of clinically significant abnormality in the 12-lead ECG at Screening, as
follows:
i. Ventricular rate <65 bpm or >115 bpm if aged 5–7 years.
ii. Ventricular rate <55 bpm or >110bpm if aged 8–11 years.
iii. PR interval >160 msec if aged 5–7 years.
iv. PR interval >170 msec if aged 8–11 years.
v. QRS >100 msec.
vi. Evidence of Mobitz II second degree or third degree AV block.
vii. Evidence of ≥2 unifocal ventricular ectopic beats, couplets, bigeminy,
trigeminy or multifocal premature ventricular complexes.
viii. QTc(B) >450 msec or an ECG that is not suitable for QT measurements
(e.g. poor defined termination of the T wave).
ix. Right or left complete bundle branch block.
x. Clinically significant conduction abnormalities (e.g., left bundle branch
block, Wolff-Parkinson-White syndrome).
xi. Clinically significant arrhythmias (e.g. atrial fibrillation, atrial flutter,
ventricular tachycardia).
xii. Non-sustained ventricular tachycardia (3 or more consecutive ventricular
beats greater than 100 bpm).

E.5 End points

E.5.1

Primary end point(s)

• Adverse events.
• Clinical laboratory assessments (hematology, chemistry and urinalysis).
• Peak expiratory flow on Days 1, 8 and 14.
• Systolic Blood Pressure (BP).
• Diastolic BP.
• Heart rate at the following times:
• Day 1 maximum and weighted mean at 0-2 h
• Day 14 maximum and weighted mean at 0–2 h and 0-8 h.
Electrocardiographic (ECG) parameters: QT duration corrected for Fridericia’s
formula (QTcF) at the following times:
• Day 1 weighted mean and peak response at 0-2 h
• Day 14 weighted mean and peak response at 0–2 h and 0-8 h.

E.5.1.1

Timepoint(s) of evaluation of this end point

•Adverse events from start of investigational product until follow up contact
•Clinical laboratory assessments at screening and on Day 14
•Peak expiratory flow at screening and on Days 1, 8, and 14 in the clinic; Days 9-13 at home.
•Systolic and diastolic blood pressure at screening, and Days 1, 8, and 14
•Heart rate and ECG at screening, and Days 1, 8 and 14

E.5.2

Secondary end point(s)

• Pharmacokinetic parameters: maximum observed plasma GW642444 maximum
observed concentration at steady-state (Cmaxss), area under the concentration-time
curve (AUC)(0-t), AUC(0-8) and time of maximum observed concentration at steady
state (Tmaxs) on Day14.
• Glucose weighted mean 0–2 h and 0–8 h and maximum (0–2 h) and maximum (0–
8 h) on Day 14.
• Potassium weighted mean 0–2 h and 0–8 h and minimum (0–2 h) and minimum (0–
8 h) on Day 14.

E.5.2.1

Timepoint(s) of evaluation of this end point

•GW642444 on Day 14
•Glucose and potassium on Day 14

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Repeat dose

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last Subject Last visit

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Children

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Subjects will not receive any additional treatment after completion of the study because other treatment options are available.

G. Investigator Networks to be involved in the Trial

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	United States

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