Clinical Trials Register

Summary
EudraCT Number:	2021-002026-24
Sponsor's Protocol Code Number:	D5982C00006
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:	2021-12-07
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

Spain - AEMPS

A.2

EudraCT number

2021-002026-24

A.3

Full title of the trial

A Randomized, Double-Blind, Parallel Group, Multicenter 24 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler and Open-Label Symbicort® Turbuhaler® in Participants with Inadequately Controlled Asthma (VATHOS)

Ensayo aleatorizado, doble ciego, de grupos paralelos y multicéntrico, de 24 semanas de duración para evaluar la eficacia y seguridad de budesónida y fumarato de formoterol en inhalador de dosis medida en comparación con budesónida en inhalador de dosis medida y con brazo abierto de Symbicort® Turbuhaler® en inhalador de dosis medida presurizada en pacientes con asma mal controlada (VATHOS).

A.3.1

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

Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler in Patients with Inadequately Controlled Asthma

Eficacia y seguridad de budesónida y fumarato de formoterol en inhalador de dosis medida en pacientes con asma controlada de forma inadecuada.

A.3.2

Name or abbreviated title of the trial where available

VATHOS

A.4.1

Sponsor's protocol code number

D5982C00006

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	AstraZeneca AB
B.1.3.4	Country	Sweden
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	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca Farmacéutica Spain, S.A.
B.5.2	Functional name of contact point	Unidad de Investigación Clínica
B.5.3	Address:
B.5.3.1	Street Address	Serrano Galvache, 56; Parque Norte, Edificio Álamo
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28033
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34900200444
B.5.6	E-mail	informacionEECC-Spain@astrazeneca.com

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	BFF MDI DFP 160
D.3.2	Product code	PT009
D.3.4	Pharmaceutical form	Pressurised inhalation, suspension
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	Budesonide
D.3.9.3	Other descriptive name	BD
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	160
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Formoterol Fumurate
D.3.9.1	CAS number	183814-30-4
D.3.9.2	Current sponsor code	FF
D.3.9.3	Other descriptive name	N/A
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4.8
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	Yes
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	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	BFF MDI DFP 80
D.3.2	Product code	PT009
D.3.4	Pharmaceutical form	Pressurised inhalation, suspension
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	Budesonide
D.3.9.3	Other descriptive name	BD
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Formoterol Fumurate
D.3.9.1	CAS number	183814-30-4
D.3.9.2	Current sponsor code	FF
D.3.9.3	Other descriptive name	N/A
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4.8
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	Yes
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	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	BD MDI DFP 160
D.3.2	Product code	PT008
D.3.4	Pharmaceutical form	Pressurised inhalation, suspension
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	Budesonide
D.3.9.3	Other descriptive name	BD
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	160
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	Yes
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	SYMBICORT® 200 TURBUHALER®
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca Canada Inc.
D.2.1.2	Country which granted the Marketing Authorisation	Canada
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	Inhalation powder
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	Budesonide
D.3.9.3	Other descriptive name	BD
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	160
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Formoterol Fumarate
D.3.9.1	CAS number	183814-30-4
D.3.9.2	Current sponsor code	FF
D.3.9.3	Other descriptive name	N/A
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4.5
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	Yes
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

Inadequately Controlled Asthma

Asma controlada de forma inadecuada

E.1.1.1

Medical condition in easily understood language

Asthma

Asma

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	PT
E.1.2	Classification code	10003553
E.1.2	Term	Asthma
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To assess the effect of BFF MDI 320/9.6 μg relative to BD MDI (superiority) on lung function in participants with inadequately controlled asthma

Evaluar el efecto del inhalador en dosis media (MDI) de BFF 320/9,6 μg con respecto al MID de BD (superioridad) sobre la función pulmonar en participantes con asma controlada de forma inadecuada

E.2.2

Secondary objectives of the trial

1. To assess the effect of BFF MDI 320/9.6 μg relative to BD MDI 320 μg (superiority) on lung function.

2. To assess the effect of BFF MDI 320/9.6 μg relative to BD MDI 320 μg on symptoms and patient reported outcomes.

1. Evaluar el efecto de MDI BFF 320/9,6 μg con respecto a MDI BD 320 μg (superioridad) sobre la función pulmonar.

2. Evaluar el efecto de MDI BFF 320/9,6 μg con respecto a MDI BD 320 μg sobre los síntomas y los resultados comunicados por el paciente.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. 12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.

2. Participants who have a documented history of physician-diagnosed asthma ≥ 6 months prior
to Visit 1, according to GINA guidelines [GINA 2020]. Healthcare records for 1 year
prior to Visit 1 must be provided for adolescent participants (12 to < 18 years of age) to
ensure consistent evaluation and follow-up of treatment in those participants.

3. Participants who have been regularly using a stable daily ICS or an ICS/LABA regimen
(including a stable ICS dose), with the ICS doses, for at least 8 weeks prior to Visit 1.

4. ACQ-7 total score ≥ 1.5 at Visits 1 and 4.

5. Pre-bronchodilator/pre-dose FEV1 <90% predicted normal value at Visits 1, 2 and 3, and a pre-dose FEV1 of 50% to 90% at Visit 4 (pre-randomization).

6. Reversibility to salbutamol, defined as a post-salbutamol increase in FEV1 of ≥ 12% and ≥ 200 mL for participants ≥ 18 years of age OR a post-salbutamol increase of FEV1 of ≥ 12% for participants 12 to < 18 years of age, either in the 12 months prior to Visit 1 or at Visit 2 or Visit 3.

7. A pre-bronchodilator/pre-dose FEV1 at Visits 2, 3, and 4 that have not changed 20% or
more (increase or decrease) from the pre-bronchodilator/pre-dose FEV1 recorded at the
previous visit.

8. Demonstrate acceptable MDI administration technique.

9. eDiary compliance ≥ 70% during screening, defined as completing the daily eDiary and
answering “Yes” to taking 2 puffs of run-in BD MDI for any 10 mornings and 10
evenings in the last 14 days prior to randomization.

1. De 12 a 80 años, hombres y mujeres, IMC < 40 kg/m2; las mujeres no deben poder quedarse embarazadas o bien deben utilizar un método anticonceptivo altamente eficaz.

2. Los participantes que tienen antecedentes documentados de asma diagnosticada por un médico ≥6 meses antes de la visita 1, de acuerdo con las guías GINA [GINA 2020]. Los participantes adolescentes (de 12 a <18 años de edad) deben proporcionar su historia sanitaria durante 1 año antes de la visita 1 para garantizar una evaluación y un seguimiento congruentes del tratamiento en esos participantes.

3. Los participantes que han estado siguiendo habitualmente una pauta diaria estable de CI o de CI/LABA (incluida una dosis estable de CI), con las dosis de IC, durante al menos 8 semanas antes de la visita 1.

4. Puntuación total de ACQ-7 ≥ 1,5 en las visitas 1 y 4.

5. VEMS prebroncodilatador/predosis de <90 % del valor normal previsto en las visitas 1, 2 y 3, y un VEMS predosis del 50 % al 90 % en la visita 4 (antes de la aleatorización).

6. Reversibilidad al salbutamol, definida como un aumento posterior al salbutamol en el VEMS de ≥12 % y ≥200 ml para participantes de ≥18 años O un aumento posterior al salbutamol del VEMS de ≥12 % para participantes de 12 a <18 años, ya sea en los 12 meses anteriores a la visita 1 o en la visita 2 o 3.

7. Un VEMS prebroncodilatador/predosis en las visitas 2, 3 y 4 que no haya cambiado en un 20 % o más (aumento o disminución) del VEMS prebroncodilatador/predosis registrado en la visita anterior.

8. Demostrar una técnica de administración de MDI aceptable.

9. Cumplimiento del diario electrónico de ≥70 % durante la selección, definido como completar el eDiary diario y responder «Sí» a aplicar 2 inhalaciones de MDI dos veces al día de preinclusión durante 10 mañanas y 10 noches en los 14 días previos a la aleatorización.

E.4

Principal exclusion criteria

1. Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s).
2. Any respiratory infection or asthma exacerbation treated with systemic corticosteroids and/or additional ICS treatment in the 8 weeks prior to Visit 1 and throughout the Screening Period.
3. Hospitalization for asthma within 8 weeks of Visit 1.
4. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary (eg, active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, and COPD). Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis.
5. Known history of drug or alcohol abuse within 12 months of Visit 1.
6. Use of a nebulizer or a home nebulizer for receiving asthma medications.
7. Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months prior to Visit 1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).
8. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.
9. For women only – currently pregnant (confirmed with positive highly sensitive urine pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.

1. Asma potencialmente mortal se define como aquellos antecedentes de episodios de asma importantes que necesitan intubación asociados con hipercapnia, paro respiratorio, convulsiones hipóxicas o episodios sincopales relacionados con el asma.
2. Cualquier infección respiratoria o empeoramiento del asma tratado con corticoides sistémicos y/o tratamiento adicional con corticoides inhalados en las 8 semanas anteriores a la visita 1 y durante el período de selección.
3. Hospitalización por asma en las 8 semanas posteriores a la visita 1.
4. Evidencia histórica o actual de una enfermedad clínicamente significativa que incluye, entre otros: cardiovascular, hepática, renal, hematológica, neurológica, endocrina, gastrointestinal o pulmonar (por ejemplo, tuberculosis activa, bronquiectasia, síndromes eosinofílicos pulmonares y EPOC). Significativa es cualquier enfermedad que, en opinión del investigador, pondría en riesgo la seguridad del participante durante su participación, o que podría afectar al análisis de eficacia o seguridad.
5. Alcoholismo o drogadicción en los 12 meses posteriores a la visita 1.
6. Uso de un nebulizador o un nebulizador doméstico para recibir medicamentos para el asma.
7. Fumadores actuales, exfumadores con antecedentes de >10 paquetes-año o exfumadores que dejaron de fumar <6 meses antes de la visita 1 (incluidas todas las formas de tabaco, cigarrillos electrónicos u otros dispositivos de vapeo y marihuana).
8. Investigadores del ensayo, investigadores colaboradores, coordinadores y sus empleados o familiares directos.
9. Solo para mujeres: embarazadas en la actualidad (confirmadas con una prueba de embarazo en orina positiva de alta sensibilidad), en período de lactancia o que tienen previsto quedarse embarazadas durante el ensayo o que no utilizan métodos anticonceptivos aceptables, según lo considere el investigador.

E.5 End points

E.5.1

Primary end point(s)

1. Europe (EU): Change from baseline in morning pre-dose trough FEV1 over 24 Weeks.

1. Europa (UE): Cambio desde el valor inicial en el VEMS mínimo antes de la dosis matutina durante 24 semanas.

E.5.1.1

Timepoint(s) of evaluation of this end point

Europe(EU) over 24 weeks.

Europa (UE) durante 24 semanas.

E.5.2

Secondary end point(s)

1. EU (Key secondary): Change from baseline in FEV1 AUC0-3 over 24 Weeks.

2. Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 24 Weeks.

3. Percentage of responders in ACQ-7 (≥ 0.5 decrease equals response) over 24 Weeks.

4. Percentage of responders in ACQ-5 (≥ 0.5 decrease equals response) over 24 Weeks.

5. Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) (≥ 0.5 increase equals response) over 24 Weeks.

6. Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1.

1. EU (Secundarios clave): Cambio desde el valor inicial en el VEMS ABC0-3 durante 24 semanas.

2. Cambio desde el valor inicial en el número medio de inhalaciones de uso de medicación de rescate (inhalaciones/día) durante 24 semanas.

3. Porcentaje de participantes que responden en ACQ-7 (una disminución de ≥0,5 es igual a respuesta) durante 24 semanas.

4. Porcentaje de participantes que responden en ACQ-5 (una disminución de ≥0,5 es igual a respuesta) durante 24 semanas.

5. Porcentaje de participantes que responden en el Cuestionario de calidad de vida en pacientes con asma durante 12 años o más (AQLQ(s)+12) (un aumento de ≥0,5 es igual a respuesta) durante 24 semanas.

6. Comienzo de la medida el día 1: Cambio absoluto en el VEMS a los 5 minutos el día 1.

E.5.2.1

Timepoint(s) of evaluation of this end point

Treatment period

Período de tratamiento

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

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

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

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

Yes

E.8.1.7.1

Other trial design description

Estudio doble ciego, abierto para Symbicort

Open label for Symbicort

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

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

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

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

Canada

Germany

Italy

Japan

Spain

United States

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

The study will end when the last remaining participant completes his/her Week 24 Visit and subsequent 2-week follow-up phone call. If study intervention was discontinued prior to the Week 24 Visit, then study will end at the completion of the Week 24 Visit.

El ensayo finalizará cuando el último participante restante complete su visita de la semana 24 y la posterior llamada telefónica de seguimiento a las 2 semanas. Si la intervención del ensayo se interrumpió antes de la visita de la semana 24, el estudio finalizará al terminar la visita de la semana 24.

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

Number of subjects for this age range:

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.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

495

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

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

232

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)

At the end of the Randomized Treatment Period, the Investigator or treating physician of the participant will prescribe alternative asthma therapy for the participant. There will be no provisions to supply BFF MDI, BD MDI, or Symbicort after the end of the treatment period.

Al final del período de tratamiento aleatorizado, el investigador o el médico responsable del participante le recetará un tratamiento alternativo para el asma. No habrá suministro de MDI BFF, MDI BD ni Symbicort después del final del período de tratamiento.

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

2022-03-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-02-16

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

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Orphan Designation Number:
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