Clinical Trials Register

Summary
EudraCT Number:	2019-000266-37
Sponsor's Protocol Code Number:	Version7-20/12/2018
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-06-11
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

Spain - AEMPS

A.2

EudraCT number

2019-000266-37

A.3

Full title of the trial

Randomized clinical trial to evaluate the efficacy and safety of the treatment with supplementary oxygen in patients with Intermediate-Risk pulmonary embolism (PE)

Ensayo clínico aleatorizado para evaluar la eficacia y seguridad clínicas del tratamiento con oxígeno suplementario en pacientes con tromboembolia de pulmón (TEP) de riesgo intermedio

A.3.1

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

Study to evaluate the use of supplemental oxygen in patients with acute symptomatic pulmonary embolism.

Estudio para evaluar el uso de oxígeno suplementario en pacientes con embolia de pulmón aguda sintomática

A.3.2

Name or abbreviated title of the trial where available

AIRE

A.4.1

Sponsor's protocol code number

Version7-20/12/2018

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	Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal
B.1.3.4	Country	Spain
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	Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	S&H Medical Science Service
B.5.2	Functional name of contact point	Clinical Trials information
B.5.3	Address:
B.5.3.1	Street Address	C/ Espronceda, 27, Entreplanta
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28003
B.5.3.4	Country	Spain
B.5.4	Telephone number	34915357183
B.5.6	E-mail	almudena.sanchez@shmedical.es

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.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Respiratory use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	OXYGEN
D.3.9.3	Other descriptive name	Medicinal oxygen
D.3.9.4	EV Substance Code	SUB14733MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	35
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

Acute symptomatic pulmonary embolism

Embolismo pulmonar agudo sintomático

E.1.1.1

Medical condition in easily understood language

Pulmonary embolism

Embolia de pulmón

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

Evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-Risk pulmonary embolism.

Evaluar la eficacia del tratamiento con oxígeno suplementario, añadido al tratamiento anticoagulante convencional, en pacientes con tromboembolia de pulmón (TEP) de riesgo intermedio.

E.2.2

Secondary objectives of the trial

Evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-Risk pulmonary embolism

Evaluar la seguridad del tratamiento con oxígeno suplementario, añadido al tratamiento anticoagulante convencional, en pacientes con tromboembolia de pulmón (TEP) de riesgo intermedio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Confirmed PE by multidetector computed tomographic pulmonary angiography (MDCT).
2) Disfuntion of right ventricle (quotient between RVDD and LVDD > 1.0 in the apical 4-chamber view) in the echocardiogram performed in the first 12 hours after PE diagnosis.
3) Signed and dated informed consent of the subject.

1) TEP aguda sintomática confirmada mediante angiotomografía computerizada (TC) multidetector positiva;
2) Disfunción del ventrículo derecho* en la ecocardiografía realizada en las primeras 12 horas tras el diagnóstico de TEP;
3) Firma del consentimiento informado.

E.4

Principal exclusion criteria

1) < 18 years old.
2) Allergy to iodinated contrast.
3) Renal failure defined as a creatinine clearance less than 30 mL/min, according to the Cockcroft-Gault formula.
4) Use of chronic oxygen therapy.
5) Hypercapnia (pCO2 >50 mmHg at the time of diagnosis).
6) Basal echocardiography technically unsuitable.
7) Contraindication to anticoagulant therapy.
8) Symptoms duration >10 days.
9) Haemodynamic instability.
10) Participation in other clinical trials for PE treatment during the present clinical trial.
11) Inability to use mask or nasal prongs.
12) Life expectancy less than 90 days.

1) Edad <18 años;
2) Alergia a contrastes iodados;
3) Insuficiencia renal grave (definida por una creatinina sérica >2 mg/dL o por un aclaramiento de creatinina <30 mL/min, según la fórmula de Cockcroft-Gault);
4) Uso de oxigenoterapia crónica domiciliaria;
5) Hipercapnia (pCO2 >50 mmHg en el momento del diagnóstico);
6) Ecocardiografía basal técnicamente inadecuada;
7) Contraindicación para el tratamiento anticoagulante (a criterio del investigador responsable);
8) Duración de los síntomas >10 días;
9) Inestabilidad hemodinámica (tensión arterial sistólica <90 mm Hg, necesidad de drogas vasoactivas [a criterio del médico responsable del paciente], de reanimación cardiopulmonar, de intubación o de tratamiento trombolítico);
10) Participación en otro ensayo clínico para el tratamiento de la TEP;
11) Incapacidad para usar mascarilla o gafas nasales;
12) Esperanza de vida estimada <90 días.

E.5 End points

E.5.1

Primary end point(s)

Modification of the right ventricle (RV) to the left ventricle (LV) diameter ratio measured 48 hours after initiation of therapy

Modificación del cociente entre el diámetro del ventrículo derecho y el diámetro del ventrículo izquierdo medido a las 48 horas del inicio del tratamiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

48 hours

48 horas

E.5.2

Secondary end point(s)

Modification of the RV to the LV diameter ratio measured 7 days after initiation of therapy.

Modificación del cociente entre el diámetro del ventrículo derecho y el diámetro del ventrículo izquierdo medido a los 7 días del inicio del tratamiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

7 days

7 días

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

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)

Yes

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

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

Yes

E.8.2.3.1

Comparator description

Tratamiento convencional

Conventional treatment

E.8.2.4

Number of treatment arms in the trial

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

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

LVLS

Última visita del último sujeto incluido en el ensayo

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

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

100

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)

None

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

2019-06-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-06-12

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

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