Clinical Trials Register

Summary
EudraCT Number:	2010-019095-70
Sponsor's Protocol Code Number:	LPA112186
National Competent Authority:	Romania - National Agency for Medicines and Medical Devices
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2010-05-13
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
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Romania - National Agency for Medicines and Medical Devices

A.2

EudraCT number

2010-019095-70

A.3

Full title of the trial

A Randomised Double-Blind, Double-Dummy, Placebo-Controlled, Stratified, Parallel-Group, Multicentre, Dose Ranging Study to Evaluate the Efficacy and Safety of GSK2190915 Tablets Administered Once Daily, Fluticasone Propionate Inhalation Powder 100mcg Twice Daily and Montelukast 10mg Daily compared with Placebo for 8 Weeks in Adolescent and Adult Subjects with Persistent Asthma while Treated with Short Acting Beta2-agonist

A.4.1

Sponsor's protocol code number

LPA112186

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GlaxoSmithKline Research and 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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	GSK2190915
D.3.2	Product code	GSK2190915
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	10 to 200
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	Singulair 10 mg Tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	montelukast
D.3.4	Pharmaceutical form	Capsule, hard
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	Flixotide Accuhaler 100 mcg
D.2.1.1.2	Name of the Marketing Authorisation holder	Glaxo Wellcome UK Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Flixotide Accuhaler 100 mcg
D.3.2	Product code	fluticasonum propionat
D.3.4	Pharmaceutical form	Inhalation powder, pre-dispensed
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	397864-44-7
D.3.9.3	Other descriptive name	FLUTICASONE FUROATE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.1
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
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

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.1
E.1.2	Level	LLT
E.1.2	Classification code	10003553
E.1.2	Term	Asthma

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to evaluate the efficacy, dose response and safety of four doses of GSK 2190915 (10mg, 30mg, 100mg and 300mg)

E.2.2

Secondary objectives of the trial

The secondary objectives are to undertake an exploratory analysis of the efficacy of
GSK2190915 relative to low dose ICS (FP 100mcg BID) and a LTRA (montelukast 10mg) and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in a population with persistent asthma.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age: 12 years of age

Gender: Male or Eligible Female

Asthma Diagnosis: Asthma as defined by the National Institutes of Health
Severity of Disease:FEV1 of 50%-85% of the predicted normal value AND Post-salbutamol/albuterol FEV1/FVC ratio of >0.70 at Screening (Visit 1)

Reversibility of Disease: Demonstrated a ≥ 12% and ≥200mL reversibility of FEV1
within approximately 30 minutes [±15 minutes] following up to 4 inhalations of
salbutamol/albuterol inhalation aerosol (spacer permitted for reversibility testing if
required) or one nebulised salbutamol/albuterol solution during Visit 1 (Screening).

Current Anti-Asthma Therapy: For ≥3 months preceding Visit 1, subjects must
have been using a short-acting beta2-agonist bronchodilator and must be able to
replace their current short acting beta2-agonist with salbutamol/albuterol inhalation
aerosol at Visit 1 for use as needed for the duration of the study.

Tobacco Use: The following subjects may be included:
• Non-smokers or Former Smokers with a documented smoking history of ≤ 10
pack years* at Visit 1. A former smoker may not have used tobacco products
within the past 6 months (i.e., cigarettes, cigars, or pipe tobacco).
• Current smokers with a documented smoking history of ≤ 10 pack years* at
Visit 1
(*10 pack years = 20 cigarettes/day for 10 years)
QTc Criteria: (machine or manual overread, males or females); QTc(F)< 450msec or
QTc(F)< 480 msec for subjects with Bundle Branch Block

Liver Function Tests:
- ALT<2 x ULN (upper limit of normal)
- AST<2 x ULN
- Alk Phos ≤ 1.5 x ULN
- Bilirubin ≤ 1.5 x ULN (isolated bilirubin>1.5 ULN is acceptable if bilirubin is
fractionated and direct bilirubin <35%)

Informed Consent: All subjects must be able and willing to give written informed
consent to take part in the study.

E.4

Principal exclusion criteria

History of Life-threatening asthma: Defined for this protocol as an asthma
episode that required intubation and/or was associated with hypercapnea,
respiratory arrest or hypoxic seizures in the previous 5 years.

Asthma Exacerbation: Any asthma exacerbation requiring oral corticosteroids
within 3 months prior to Visit 1. A subject must not have had any hospitalisation
for asthma within 6 months prior to Visit 1.

Respiratory Infection: Culture-documented or suspected bacterial or viral
infection of the upper or lower respiratory tract, sinus or middle ear that is not
resolved within the 4 weeks before Visit 1 and led to a change in asthma
management or treatment with antibiotics, or in the opinion of the Investigator is
expected to affect the subject’s asthma status or the subject’s ability to participate
in the study.

Corticosteroid Use:
• Administration of inhaled corticosteroids within 6 weeks prior to Visit 1
• Administration of systemic, oral or depot corticosteroids within 12 weeks
prior to Visit 1

OATP1B1 substrates: Subjects who have received OATP1B1 substrates within
4 weeks prior to Visit 1 (e.g. rosuvastatin, pravastatin, cerivastatin, pitavastatin,
atorvastatin, simvastatin, fluvastatin, lovastatin, rifampicin,
bromosulphophthalein, benzylpenicillin, methotrexate).

Immunosuppressive Medications: A subject must not be using, or require use,
of immunosuppressive medications during the study.

Liver disease: Current or chronic history of liver disease, known hepatic or
biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic
gallstones), presence of hepatitis B surface antigen (HBsAg), positive hepatitis C
test result within 3 months prior to Visit 1.

Concurrent Diseases/Abnormalities: Historical or current evidence of clinically
significant uncontrolled disease including, but not limited to: cardiovascular
disease, hepatic disease, renal disease, haematological disease, neurological
disease, psychiatric disease or pulmonary disease (including, but not confined to
chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic
fibrosis, bronchopulmonary dysplasia, and chronic obstructive pulmonary
disease). Significant is defined as any disease that, in the opinion of the
investigator, would put the safety of the subject at risk through participation, or
which would affect the efficacy or safety analysis if the disease/condition
exacerbated during the study.

Investigational Medications: A subject must not have participated in a study or
used any investigational drug within 30 days prior to Visit 1.

Drug Allergy: Any adverse reaction including immediate or delayed
hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal,
inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the
constituents of ACCUHALER/DISKUS (i.e. lactose).

Milk Protein Allergy: History of severe milk protein allergy.

Compliance: A subject will not be eligible if he/she or his/her parent or legal
guardian has any infirmity, disability, or geographical location which seems likely
(in the opinion of the Investigator) to impair compliance with any aspect of this
study protocol or scheduled visits to the study centre and non-compliant with
study medication or procedures (e.g. completion of eDiary)

History of alcohol or drug abuse: History of drug or alcohol abuse or
neurological or psychiatric disease of which in the opinion of the investigator
could interfere with the subject’s proper completion of the protocol requirements

E.5 End points

E.5.1

Primary end point(s)

Mean change from baseline to the end of the 8-week treatment period in trough (AM
pre-dose and pre-rescue bronchodilator) FEV1

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

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

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

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Montelukast (Singulair 10 mg tablets) and Flixotide Accuhaler 100 mcg

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

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

End of trial is last subject last visit

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

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.1.1.1

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)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

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

Yes

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

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

275

F.4.2.2

In the whole clinical trial

630

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)

No extension to the study is planned and no post study treatment will be available

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2010-09-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-07-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-10-06

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