Clinical Trials Register

Summary
EudraCT Number:	2016-000164-42
Sponsor's Protocol Code Number:	2016RC01
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2019-07-09
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

UK - MHRA

A.2

EudraCT number

2016-000164-42

A.3

Full title of the trial

JAB02 Repurposing allopurinol as a novel anti-inflammatory treatment for persistent allergic asthma.

A.3.1

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

investigating the use of allopurinol as treatment for allergic asthma

A.3.2

Name or abbreviated title of the trial where available

JAB02 Allopurinol as a novel anti-inflammatory treatment for Asthma

A.4.1

Sponsor's protocol code number

2016RC01

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	Tayside Medical Sciences Centre on behalf of University of Dundee
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Non-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	University of Dundee
B.5.2	Functional name of contact point	Lipworth
B.5.3	Address:
B.5.3.1	Street Address	Scottish Centre for Respiratory Research, Ninewells Hospital & Medical School
B.5.3.2	Town/ city	Dundee
B.5.3.3	Post code	DD1 9SY
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	01382 383188
B.5.5	Fax number	01382 383259
B.5.6	E-mail	b.j.lipworth@dundee.ac.uk

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	Allopurinol
D.2.1.1.2	Name of the Marketing Authorisation holder	Tayside Pharmaceuticals, Ninewells Hospital, Dundee, DD1 9SY
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	Allopurinol
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Allopurinol
D.3.9.1	CAS number	315-30-0
D.3.9.4	EV Substance Code	AS1
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	300
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	Capsule, hard
D.8.4	Route of administration of the placebo	Oral 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

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10001705
E.1.2	Term	Allergic asthma
E.1.2	System Organ Class	100000004855

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Does allopurinol confer any anti-inflammatory benefit to the airways of patients with asthma? In specific, does it reduce airway hyperresponsiveness (a marker of disease activity). This will be measured by challenging the airways with a drug designed to provoke bronchoconstriction.

We hypothesise that patients on allopurinol will be less reactive to the bronchial challenge. Thereby demonstrating it has tangible anti-inflammatory properties to the airways of asthmatic patients.

E.2.2

Secondary objectives of the trial

Does allopurinol improve conventional measures of pulmonary function based on the breathing tests of spirometry (a forced breathing test), impulse oscillometry (a passive breathing test), Exhaled nitric oxide (passive), blood tests that measure inflammation in asthma (eosinophils, eosinophilic cationic protein), and asthma questionnaires (asthma control questionnaire, asthma quality of life questionnaire).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Male and female volunteers aged 18-65 years with stable mild to moderate asthma. Steroid naïve or receiving inhaled steroid up to 1000μg/day BDP equivalent dose, who are responsive to bronchial mannitol challenge – i.e. with a provocative mannitol dose to produce a 15 % fall in FEV1 (PD15) ≤635mg for bronchial challenge. Patients must be able to step down and stop inhaled corticosteroids (ICS), long acting β-2 agonists (LABAs), leukotriene receptor antagonists (LTRAs), cromones, antihistamines, and remain be clinically stable throughout the study. This is defined as: FEV1 ≥60% predicted; Peak flow (PEF) ≥70% of reference value at screening; reliever use not >8puffs/day on two consecutive days

E.4

Principal exclusion criteria

Other significant pulmonary disease (e.g. COPD) Smoking within 12 months of screening visit, uncontrolled symptoms of asthma; Pregnancy or lactation; known or suspected sensitivity to IMP; Inability to comply with protocol; Any clinically significant medical condition that may endanger the health or safety of the participant, or jeopardise the protocol; An asthma exacerbation requiring systemic steroids within 3 months of study commencement; Taking prohibited medication (as defined in protocol), Participation in another CTIMP within the past 30 days.

E.5 End points

E.5.1

Primary end point(s)

Mannitol PD15 (Provocation dose of mannitol causing 15% drop in FEV1)

E.5.1.1

Timepoint(s) of evaluation of this end point

14 days (but allowed + 3 days over this for flexibility of visits)

E.5.2

Secondary end point(s)

Spirometry
IOS
FeNO
Salbutamol recovery post-mannitol challenge
Blood eosinophils and serum ECP
IgE (immunoglobulin E)
AQLQ (Asthma Quality of Life Questionnaire)
ACQ (Asthma Control Questionnaire)
Asthma VAS (Asthma Visual Analogue Scale)

E.5.2.1

Timepoint(s) of evaluation of this end point

14 days (but allowed + 3 days over this for flexibility of visits)

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

Yes

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

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

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

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.8.6 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

after safety follow up, 7 days post LVLS

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

F.1.1