Clinical Trials Register

Summary
EudraCT Number:	2016-004033-25
Sponsor's Protocol Code Number:	PED-FQ-2016
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-03-31
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

2016-004033-25

A.3

Full title of the trial

Efect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trial

Efecto del bicarbonato nebulizado en vía aérea sobre las infecciones bacterianas en pacientes con fibrosis quística. Ensayo clínico aleatorizado.

A.3.1

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

Randomized clinical trial to assess the effect of nebulizad bicarbonate on bacterial infections in patients with cystic fibrosis

Ensayo clínico aleatorizado para evaluar el efecto del bicarbonato nebulizado sobre las infecciones bacterianas en pacientes con fibrosis quística

A.4.1

Sponsor's protocol code number

PED-FQ-2016

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	Fundació Parc Taulí
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	Fundació Parc Taulí
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	Hospital Universitari Parc Tauli
B.5.2	Functional name of contact point	Oficina de Recerca
B.5.3	Address:
B.5.3.1	Street Address	Parc Taulí, 1
B.5.3.2	Town/ city	Sabadell
B.5.3.3	Post code	08208
B.5.3.4	Country	Spain
B.5.4	Telephone number	34937458451
B.5.5	Fax number	34937175067
B.5.6	E-mail	afarre@tauli.cat

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.2.1.2	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.3.1	Product name	Sodium bicarbonate
D.3.4	Pharmaceutical form	Solution for injection
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	Sodium Bicarbonate
D.3.9.1	CAS number	144-55-8
D.3.9.3	Other descriptive name	SODIUM BICARBONATE BP
D.3.9.4	EV Substance Code	SUB169196
D.3.10	Strength
D.3.10.1	Concentration unit	mol/l mole(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
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	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.2.1.2	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.3.1	Product name	sodium chloride
D.3.4	Pharmaceutical form	Concentrate for solution for injection
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	Sodium chloride
D.3.9.1	CAS number	7647-14-5
D.3.9.3	Other descriptive name	SODIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12581MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/ml gram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.2
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.2.1.2	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.3.1	Product name	sodium chloride
D.3.4	Pharmaceutical form	Concentrate for solution for injection
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	Sodium chloride
D.3.9.1	CAS number	7647-14-5
D.3.9.3	Other descriptive name	SODIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12581MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g/ml gram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.2
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.2.1.2	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.3.1	Product name	Water for injections
D.3.4	Pharmaceutical form	Solvent for parenteral use
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	water for injections
D.3.9.1	CAS number	7789-20-0
D.3.9.3	Other descriptive name	WATER FOR INJECTIONS, EP
D.3.9.4	EV Substance Code	SUB45376
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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	Solution for injection
D.8.4	Route of administration of the placebo	Inhalation use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Cystic Fibrosis

Fibrosis Quística

E.1.1.1

Medical condition in easily understood language

Cystic Fibrosis

Fibrosis Quística

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	10074550
E.1.2	Term	Preventive antimicrobial therapy in cystic fibrosis
E.1.2	System Organ Class	100000004865

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	10011764
E.1.2	Term	Cystic fibrosis NOS
E.1.2	System Organ Class	100000004850

E.1.3

Condition being studied is a rare disease

Yes

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the effect of nebulized bicarbonate on bacterial infections in the airway of patients with CF diagnosis.

Valorar el efecto del bicarbonato nebulizado sobre las infecciones bacterianas en la vía aérea, de pacientes con diagnóstico de FQ.

E.2.2

Secondary objectives of the trial

- Analyze the pH variation of the airway after nebulized bicarbonate therapy.
- To evaluate the cellular inflammatory changes that occur in the sputum, after nebulization with bicarbonate.
- To compare the effect on bronchial obstruction of nebulized bicarbonate in the airway versus hypertonic saline solution 7% using the Leicester Cuestionario.
- To compare the number of patients chronified at the end of the study, in both groups.
- To compare the quality of life of patients in groups A and B.
- Assess adherence to treatment by controlling the dispensing and the Morinsky-Green test.
- Analyze possible adverse reactions.

- Analizar la variación de pH de la vía aérea tras la terapia con bicarbonato nebulizado.
- Valorar los cambios inflamatorios celulares que se producen en el esputo, tras la nebulización con bicarbonato.
- Comparar el efecto sobre la obstrucción bronquial del bicarbonato nebulizado en la vía aérea versus el suero salino hipertónico 7% mediante el Cuestionario tos Leicester .
- Comparar el número de pacientes cronificados al final del estudio, en ambos grupos.
- Comparar la calidad de vida de los pacientes de los grupos A y B.
- Valorar la adherencia al tratamiento mediante el control de la dispensación y el test de Morinsky-Green.
- Analizar las posibles reacciones adversas.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients of both genders with CF diagnosis.
- FEV1> 40%.
- Age over 6 years.
- Patients with sputum culture negative for Pseudomonas
- Patients who give their informed consent or whose representative gives informed consent to participate in the study.

- Pacientes de ambos géneros con diagnóstico de FQ.
- FEV1 >40%.
- Edad mayor de 6 años.
- Pacientes con cultivo de esputo negativo para Pseudomonas
- Pacientes que otorguen su consentimiento informado o cuyo representante otorgue el consentimiento informado a participar en el estudio.

E.4

Principal exclusion criteria

- Pregnant or lactating women
- Women of childbearing potential, not using valid contraceptive methods:
- Abstinence
- Surgical sterilization
- Male partner sterilization
- Barrier contraceptive methods
- Hormonal contraceptive methods or other with similar efficacy
- Baseline oxygen saturation <92% or supplementary oxygen needs at home.
- Masive Hemoptysis
- Patients colonized by pseudomonas
- Patients who are not able to follow study assessments according to protocol
- Any circumstance that at the discretion of the physician may pose a risk or clinical harm to the patient's participation in the study or interfere with the assessments of the same.

- Mujeres embarazadas o en período de lactancia
- Mujeres en edad fértil, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, salvo que estén utilizando métodos básicos de anticoncepción durante la administración del fármaco en investigación. Los métodos anticonceptivos básicos incluyen:
o Abstinencia total (cuando esté en consonancia con el estilo de vida habitual y preferido del paciente). La abstinencia periódica (p. ej., calendario, ovulación, métodos sintotérmicos, postovulación) y el coitus interruptus no son métodos anticonceptivos aceptables.
o Esterilización de la mujer (ha sido sometida a ooforectomía bilateral quirúrgica con o sin histerectomía), histerectomía total o ligadura de trompas al menos seis semanas antes de tomar el fármaco en investigación. Si sólo se ha realizado ooforectomía, sólo cuando se ha confirmado el estado reproductivo de la mujer mediante el seguimiento de la evaluación del nivel hormonal.
o Esterilización del varón (al menos 6 meses antes de la selección). Para las pacientes mujeres participantes en el estudio, la pareja varón vasectomizado debería ser la única pareja de dicha paciente.
o Métodos anticonceptivos de barrera: preservativo o tapón oclusivo (diafragma o capuchón en bóveda/cervical). Para RU: con un gel/ espuma/ película/ crema/ supositorio vaginal espermicida.
o Uso de métodos anticonceptivos hormonales orales, (estrógenos y progesterona), inyectados o implantados u otras formas de anticoncepción hormonal que tengan eficacia comparable (tasa de fallo <1%); por ejemplo, anillo hormonal vaginal o anticoncepción hormonal transdérmica o colocación de un dispositivo intrauterino (DIU) o sistema intrauterino (SIU).
En caso de utilizar anticonceptivos orales, las mujeres deberán haber utilizado de forma estable la misma píldora durante un mínimo de 3 meses antes de tomar el fármaco en investigación.
- Se considera que una mujer es posmenopáusica y no fértil si lleva 12 meses de amenorrea natural (espontánea) con un perfil clínico apropiado (p. ej., edad apropiada, antecedentes de síntomas vasomotores) o si ha sido sometida a ooforectomía bilateral quirúrgica (con o sin histerectomía), histerectomía total o ligadura de trompas al menos seis semanas antes. Si sólo se ha realizado ooforectomía, se considerará que una mujer no es fértil sólo cuando se haya confirmado el estado reproductivo de la mujer mediante el seguimiento de la evaluación del nivel hormonal.
- Saturación basal de oxígeno <92% o necesidades de oxígeno suplementario domiciliario.
- Hemoptisis masiva
- Pacientes colonizados por pseudomonas
- Pacientes que no sean capaces de seguir las valoraciones del estudio según el protocolo
- Cualquier circunstancia que a criterio del médico le pueda suponer un riesgo o perjuicio clínico la participación del paciente en el estudio ó que interfiera en las valoraciones del mismo.

E.5 End points

E.5.1

Primary end point(s)

Number of sputum cultures positive to Pseudomonas, taken at each follow-up visit during the year of study.

Número de cultivos de esputo positivos a Pseudomonas, tomado en cada visita de seguimiento durante el año de estudio.

E.5.1.1

Timepoint(s) of evaluation of this end point

Every 8 weeks during 52 weeks

Cada 8 semanas durante 52 semanas

E.5.2

Secondary end point(s)

- Number of sputum cultures positive for staphylococcus and other bacteria, mycobacteria and fungi, taken at each follow-up visit during the year of study.
- Time between the start of the study and the first culture of positive sputum.
- Changes in the pH of the airway fluid measured in the induced sputum in each visit compared to baseline
- Changes in the quality of life test score in each visit compared to baseline
- Changes from baseline in total lung volume by plethysmography at 12 months of treatment
- Changes in the cellularity of the induced sputum in each of the visits
- Leicester Cough Questionnaire on each visit
- Adverse reactions
- Morinsky adhesion test
- Number of exacerbations per patient at end of study
- Evolution with respect to baseline in FEV1 by spirometry in each of the study visits
- Vitamin A, D, E levels, prothrombin time and thromboplastin time
- Sobel test at 12 months of treatment
- Radiological changes in the pulmonary parenchyma by pulmonary CT of low irradiation at 12 months of treatment

Número de cultivos de esputo positivos a staphilococos y otras bacterias, micobacterias y hongos, tomado en cada visita de seguimiento durante el año de estudio.
- Tiempo entre el inicio del estudio y el primer cultivo de esputo positivo.
- Cambios en el pH del líquido periciliar medido en el esputo inducido en cada una de las visitas respecto del valor basal
- Cambios en la puntuación del Test de calidad de vida en cada una de las visitas con respecto al valor basal
- Cambios con respecto de la basal en el volumen pulmonar total por pletismografia a los 12 meses de tratamiento
- Cambios en la celularidad del esputo inducido en cada una de las visitas
- Cuestionario de Tos de Leicester en cada una de las visitas
Reacciones adversas
- Test de adherencia de Morinsky
- Número de exacerbaciones por paciente al final del estudio
- Evolución con respecto de la basal en el FEV1 por espirometría en cada una de las visitas del estudio
- Niveles de vitaminas A,D,E, tiempo de protrombina y tiempo de tromboplastina
- Test de sobel a los 12 meses de tratamiento
- Cambios radiológicos en el parenquima pulmonar mediante TAC pulmonar de baja irradiación a los 12 meses de tratamiento

E.5.2.1

Timepoint(s) of evaluation of this end point

Every 2 months during 52 weeks

Cada 2 meses durante 52 semanas

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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

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.8.5

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

Last subject last visit

último paciente última visita

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

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

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:

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

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Subjects under age of 18

Sujetos menores de 18 años

F.3.3.7

Others

Yes

F.3.3.7.1

Details of other specific vulnerable populations

patients with incurable disease

Paciente con enfermedad incurable

F.4 Planned number of subjects to be included

F.4.1

In the member state

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)

If it is favorable to use nebulized bicarbonate to prevent respiratory infections in patients with Cystic Fibrosis, it will later be included in the usual therapy after the aproval of the therapeutic institutional committee

Si resulta favorable el uso del bicarbonato nebulizado para prevenir las infecciones respiratorias en los pacientes con Fibrosis Quística, posteriormente se incluirá en la terapéutica habitual, previa aprobación del Comité terapéutico institucional

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

2017-06-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-04-11

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
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