Clinical Trials Register

Summary
EudraCT Number:	2017-002244-33
Sponsor's Protocol Code Number:	Astmaperiostin
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-06-22
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

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A. Protocol Information

A.1

Member State Concerned

Denmark - DHMA

A.2

EudraCT number

2017-002244-33

A.3

Full title of the trial

Periostin-guided withdrawal of inhaled corticosteroids in patients with
non-eosinophilic asthma

Periostin-guidet udtrapning af inhalationssteroidbehandling hos patienter med non-eosinofil astma

A.3.1

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

Periostin-guided withdrawal of inhaled corticosteroids in patients with
non-eosinophilic asthma

Periostin-guidet udtrapning af inhalationssteroidbehandling hos patienter med non-eosinofil astma

A.4.1

Sponsor's protocol code number

Astmaperiostin

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	Respiratory Research Unit Hvidovre, Department of Respiratory Medicine, Copenhagen University Hospital Hvidovre
B.1.3.4	Country	Denmark
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	Hvidovre Hospital
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Respiratory Research Unit Hvidovre, Department of Respiratory Medicine, Copenhagen University Hospital Hvidovre
B.5.2	Functional name of contact point	Respiratory Research Unit Hvidovre
B.5.3	Address:
B.5.3.1	Street Address	Kettegard Alle 30
B.5.3.2	Town/ city	Hvidovre
B.5.3.4	Country	Denmark
B.5.4	Telephone number	4538621020
B.5.6	E-mail	christiane.mosbech@regionh.dk

D. IMP Identification
D.IMP: 1
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	Budesonid
D.2.1.1.2	Name of the Marketing Authorisation holder	several companies
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	budesonid
D.3.2	Product code	budesonid
D.3.4	Pharmaceutical form
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	BUDESONIDE
D.3.9.1	CAS number	51333-22-3
D.3.9.2	Current sponsor code	budesonid
D.3.9.4	EV Substance Code	SUB05955MIG
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.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	fluticasonpropionat
D.2.1.1.2	Name of the Marketing Authorisation holder	fluticasonpropionat
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	fluticasonpropionat
D.3.2	Product code	R03BA05
D.3.4	Pharmaceutical form
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	fluticasonpropionate
D.3.9.1	CAS number	80474-14-2
D.3.9.2	Current sponsor code	fluticasonpropionat
D.3.9.3	Other descriptive name	FLUTICASONE PROPIONATE
D.3.9.4	EV Substance Code	SUB02241MIG
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.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	mometasonfuroat
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	mometasonfuroat
D.3.2	Product code	R03BA07
D.3.4	Pharmaceutical form
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	mometasonfuroate
D.3.9.2	Current sponsor code	mometasonfuroat
D.3.9.3	Other descriptive name	MOMETASONE FUROATE
D.3.9.4	EV Substance Code	SUB03318MIG
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.IMP: 4
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	fluticasonfuroat
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	fluticasonfuroat
D.3.2	Product code	R03AK10
D.3.4	Pharmaceutical form
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	FLUTICASONE FUROATE
D.3.9.1	CAS number	397864-44-7
D.3.9.2	Current sponsor code	fluticasonfuroat
D.3.9.4	EV Substance Code	SUB26593
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.IMP: 5
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	beclometasondipropionat
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BECLOMETASONE DIPROPIONATE
D.3.9.1	CAS number	5534-09-8
D.3.9.2	Current sponsor code	beclometasondipropionat
D.3.9.4	EV Substance Code	SUB00681MIG
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.IMP: 6
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	ciclesonid
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	ciclesonid
D.3.2	Product code	R03BA08
D.3.4	Pharmaceutical form
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	CICLESONIDE
D.3.9.1	CAS number	141845-82-1
D.3.9.2	Current sponsor code	ciclesonid
D.3.9.4	EV Substance Code	SUB06236MIG
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Asthma

Astma

E.1.1.1

Medical condition in easily understood language

Asthma

Astma

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	22.1
E.1.2	Level	LLT
E.1.2	Classification code	10003555
E.1.2	Term	Asthma bronchial
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

The aim is to investigate whether asthma patients expressing low T2-activity, assessed by Serum-Periostin, blood-eosinophils, and FeNO can sustain their level of disease control during tapering of ICS. The overall aim of the study is to reduce the burden of corticosteroids in these patients.

At undersøge om patienter med non-eosinofil, non-allergisk astma, dvs. med lav T2-aktivitet bedømt ud fra S-periostin, kan opretholde samme niveau af sygdomskontrol uden behandling med ICS. Det overordnede sigte med studiet er at reducere steroidbyrden hos denne gruppe af patienter med astma.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Asthma patients followed in the Respiratory Outpatient Ward, Amager Hvidovre
Hospital, Glostrup Hospital, Herlev-Gentofte Hospital, Bispebjerg Hospital.
- At least one of the following test suggestive for asthma, performed at
any time during the outpatient course:
o 1) FEV1-reversibility of at least 12% and 200 ml after administration
of bronkodilator or Prednisolon course.
o 2) positiv bronkialprovokation test, such as mannitol, or
o 3) peakflow (PF)- variation of at least 20% assessed during a 14-day period, measured twice daily and at asthmatic symptoms.
o 4) Variability in FEV1 over time on at least 12% and 200 ml
- Age 18-65 years
- Treated with ICS daily in doses equivalent to Budesonid 800 microgram daily or more
- ICS adherence of at least 80% during the last year, assessed from used prescriptions
- FeNO < 25 ppb at all prior visits
- Blood-eosinofils <0,15 at screening
- Signed informed consent
- Fertile women: negative U-HCG

- Astmapatienter som følges i Lungemedicinsk ambulatorium, Amager Hvidovre Hospital, Glostrup Hospital, Herlev-Gentofte Hospital og Bispebjerg Hospital.
- Astma diagnosen verificeret ved, på et hvilket som helst tidspunkt i ambulatorieforløbet, mindst en positiv af følgende astmatests:
o 1) FEV1-reversibilitet mindst 12 % og 200 ml efter administration af bronkodilatator eller kortiko-steroidkur.
o 2) Positiv bronkialprovokationstest, f.eks. mannitol, eller
o 3) Peak-flow-variation på mindst 20 % (14-dages periode, målt 2x dgl. samt ved astmasymptomer).
o 4) Variabilitet i FEV1 over tid på mindst 12 % og 200 ml.
- Alder 18-65 år
- I fast behandling med middel-dosis ICS eller højere (sv.t. budesonid 400 microgram x 2 dgl.)
- ICS adherence mindst 80 % seneste år (bedømt ud fra indløste recepter)
- FeNO < 25 ppb ved ambulante besøg inkl. screening
- Blod-eosinofile <0,15 mia/L ved screeningsbesøget
- For kvinder i fertil alder: negativ U-HCG samt tilkendegivelse om sikker antikonception i hele forsøgsperioden.
- Underskrevet informeret samtykke

E.4

Principal exclusion criteria

- History of allergic asthma
- Doctor-diagnosed pneumonia within 6 weeks prior to screening
- Daily smoking or former daily smoking within the last 6 months
- Known other respiratory condition such as COPD or pulmonary
sarcoidosis
- Known other chronic conditions that could impact or prevent study participation, including severe heart conditions and conditions requiring treatment with immunosuppressive drugs such as Prednisolon, Methotrexate or biological treatments, assessed by study doctor
- Pregnancy or planned pregnancy
- Abuse of alcohol or other recreational drugs

- Anamnese med allergisk astma
- Lægediagnosticeret pneumoni seneste 6 uger inden screening
- Aktuel daglig ryger eller tidligere daglig ryger indenfor de eneste 6 måneder
- Anden kendt lungesygdom, inkl. KOL og sarcoidose
- Anden kronisk sygdom som efter lægeligt skøn vurderes at have betydning for deltagelse i forsøget, f.eks. svær hjertesygdom og sygdom som behandles med fast (eller jævnligt behov for) prednisolon eller anden immuno-suppressiv medicin, f.eks. methotrexat eller behandling med biologiske lægemidler.
- Aktuel eller planlagt graviditet
- Misbrug af alkohol eller andre rusmidler

E.5 End points

E.5.1

Primary end point(s)

Change in Control Questionnaire (ACQ) from baseline to post-tapered
ICS and/or time from baseline to drop-out because of worsening of asthma symptoms. Clinically significant change will be 0.5 points.

Ændring i Asthma Control Questionnaire (ACQ) fra baseline til efter udtrappet ICS-behandling. Signifikant ændring defineres som min. 0.5 point og/eller tid til drop-out fra baseline pga. øgning i astmaaktivitet. (dvs. i alt 3.5 point).

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Week 0, 4, 8, 12, 16, 26, 52.
2. Single measurement at drop-out

1. Uge 0, 4, 8, 12, 16, 26, 52
2. Enkeltstående måling ved drop-out

E.5.2

Secondary end point(s)

1. Change in FeNO
2. Change in Serum-Periostin.
3. Change in FEV1.
4. Change in Blood-eosinophils
5. Change in Sputum-eosinophils

1. Ændring i FeNO
2. Ændring i serum-periostin
3. Ændring i FEV1
4. Ændring i blod-eosinofile
5. Ændring i sputum-eosinofile

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Week 0, 4, 8, 12, 16, 26, 52.
2. Week 0, 8, 16, 52.
3. Week 0, 4, 8, 12, 16, 26, 52.
4. Week 0, 4, 8, 12, 16, 26, 52.
5. Week 0, 52.

1. Uge 0, 4, 8, 12, 16, 26, 52.
2. Uge 0, 8, 16, 52
3. Uge 0, 4, 8, 12, 16, 26, 52.
4. Uge 0, 4, 8, 12, 16, 26, 52.
5. Uge 0, 52

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

Yes

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Comperator arm: usual asthma care. Active arm: tapering of inhaled corticosteroids

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.8.5

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

Yes

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

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

110

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

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

110

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

110

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)

When the subject has ended participation in the trial, he/she will continue treatment in the outpatient ward in the Respiratory Department of Hvidovre Univesityy Hospital

Når forsøgsperioden er slut overgår patienterne til vanlig opfølgning og behandling i ambulatorieregi.

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

2017-09-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-09-21

P. End of Trial
P.	End of Trial Status	Ongoing

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