Clinical Trials Register

Summary
EudraCT Number:	2012-002106-48
Sponsor's Protocol Code Number:	BCF-2009.01
National Competent Authority:	Ireland - HPRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-05-15
Trial 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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Ireland - HPRA

A.2

EudraCT number

2012-002106-48

A.3

Full title of the trial

An Investigative Study to characterize gene expression patterns in myeloid cells that are triggered during acute asthma exacerbations, and to identify associated genes/gene networks that are Omalizumab sensitive.

A.3.1

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

A.4.1

Sponsor's protocol code number

BCF-2009.01

A.5.4

Other Identifiers

Name:

Novartis study number

Number:

CIGE025A2213T

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	University College Dublin
B.1.3.4	Country	Ireland
B.3.1 and B.3.2	Status of the sponsor
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	Yes
D.2.1.1.1	Trade name	Xolair Powder and Solvent for Injection
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Ltd
D.2.1.2	Country which granted the Marketing Authorisation	Ireland
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.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Asthma

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

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 identify the genes/gene networks that are activated during acute asthma exacerbations and to identify those genes/gene networks that are attenuated by a short course of treatment with omalizumab initiated at the time of presentation with acute symptoms

E.2.2

Secondary objectives of the trial

The secondary objectives would be to investigate the effect of omalizumab on the recovery of lung function as captured by FEV1 and other related measures of pulmonary function following an acute asthma exacerbation

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

In order to be eligible, subjects must:
1. Have a current diagnosis of asthma
2. Have preexisting or currently documented atopy
3. Fulfil the definition in section 3.2 for acute exacerbation at the time of enrolment
4. Have a FEV1 of less than 80% of predicted
5. Be aged between 18 and 75yrs. old, inclusive
6. Have a normal chest X-ray and EKG
7. Have a normal DLCO (diffusion in the lung of carbon monoxide)
8. Have a negative urine pregnancy test (women of childbearing potential) at the Screening visit. Women who are surgically sterile or those who are post-menopausal for at least two years are not considered to be of childbearing potential.
9. Women of childbearing potential must agree to use a reliable double barrier method of contraception until study completion and for at least four weeks following their final study visit. A reliable double barrier method of contraception is considered to be a combination of TWO of the following: birth control pills/ implants/ injections. Intrauterine devices, spermicide, diaphragms or condoms.
10. Subjects must be able to provide written informed consent and must sign an REC approved informed consent form prior to initiation of any study procedures.
11. 40 subjects must have confirmed allergy and randomization will assign equal numbers of these to treatment/placebo arms (see 6.3 below).

E.4

Principal exclusion criteria

Subjects who meet any of the following criteria are ineligible for participation in the study:
1. If onset of acute exacerbation has been > 48 hours
2. If they have a total lung capacity (TLC) less than 80 % of predicted normal or a forced expiratory volume in one second (FEV1) > 80% of predicted normal at baseline
3. If there is evidence of pneumonia, COPD or congestive heart failure
4. Greater than 5 pack year history of smoking.
5. Have ever had omalizumab in the past.
6. Female subjects who are pregnant or breastfeeding
7. Presence of a serum ALT or AST greater than 2 times the upper limit of normal at any time during the Screening period
8. Have a contraindication to treatment with omalizumab.
9. Have a history of malignancy
10. Have demonstrated noncompliance with previous regimens
11. Have a recent history of abusing alcohol, or illicit drugs.
12. Have participated in a clinical study involving an investigational drug or device within four weeks before the Screening visit.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is characterization of the gene expression signature triggered in myeloid cells during acute asthma exacerbations and identification of associated genes/gene networks that are sensitive to omalizumab administration.

E.5.2

Secondary end point(s)

The secondary endpoint is the time taken to restoration of individual patients’ airway responsiveness to a stable value as measured by a bronchial challenge with Mannitol following acute severe asthma exacerbation, in patients given 2 doses of omalizumab during the exacerbation. Airway responsiveness stability will be deemed to have been achieved when an individual patient returns successive PC15 readings during follow-up which are not significantly different (i.e. ≤ 10% variability between successive PC15 readings).

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

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

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

E.8.6.2

Trial being conducted completely outside of the EEA

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

Visit 6 and End of Trial will be Day 84 +/_ 3 days from
Randomization.

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.2.1	Number of subjects for this age range:	20
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	20
F.4.2	For a multinational trial
F.4.2.2	In the whole clinical trial	20

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

2012-07-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-11-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-02-10

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials