Clinical Trials Register

Summary
EudraCT Number:	2016-000155-28
Sponsor's Protocol Code Number:	PT009003
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:	2016-10-25
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

2016-000155-28

A.3

Full title of the trial

A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess
the Efficacy and Safety of PT009 compared to PT005 on COPD
Exacerbations over a 52-Week Treatment Period in Subjects With Moderate
to Very Severe COPD

Ensayo multicéntrico, aleatorizado, doble ciego, en grupos paralelos para
evaluar la eficacia y la seguridad de PT009 en comparación con PT005 en
las exacerbaciones de EPOC durante un período de tratamiento de 52
semanas en sujetos con EPOC moderada a muy grave

A.3.1

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

A Study to Assess the Efficacy and Safety of PT009 compared to PT005 on
COPD Exacerbations over a 52-Week Period in Subjects with Moderate to
Very Severe COPD (sophos)

Ensayo para evaluar la eficacia y la seguridad de PT009 en comparación
con PT005 en las exacerbaciones de EPOC durante un período de
tratamiento de 52 semanas en sujetos con EPOC moderada a muy grave
(sophos)

A.3.2

Name or abbreviated title of the trial where available

SOPHOS

A.4.1

Sponsor's protocol code number

PT009003

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02727660

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	Pearl Therapeutics, Inc. (Pearl)
B.1.3.4	Country	United States
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	Pearl Therapeutics Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca Farmacéutica Spain SA
B.5.2	Functional name of contact point	Unidad de Investigación Clínica
B.5.3	Address:
B.5.3.1	Street Address	C/ Serrano Galvache,56
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	900200444
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	Budesonide and Formoterol Fumarate Inhalation Aerosol (BFF MDI)
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	FORMOTEROL FUMARATE
D.3.9.1	CAS number	43229-80-7
D.3.9.3	Other descriptive name	FORMOTEROL FUMARATE
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.3.8 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.3.9.4	EV Substance Code	SUB05955MIG
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	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	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	Budesonide and Formoterol Fumarate Inhalation Aerosol (BFF MDI)
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.3.9.3	Other descriptive name	BUDESONIDE
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 FUMARATE
D.3.9.1	CAS number	43229-80-7
D.3.9.3	Other descriptive name	FORMOTEROL FUMARATE
D.3.9.4	EV Substance Code	SUB02257MIG
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	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	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	Formoterol Fumarate Inhalation Aerosol (FF MDI)
D.3.2	Product code	PT005
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	FORMOTEROL FUMARATE
D.3.9.1	CAS number	43229-80-7
D.3.9.3	Other descriptive name	FORMOTEROL FUMARATE
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	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

Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Enfermedad Pulmonar Obstructiva Crónica de moderada a
muy grave (EPOC)

E.1.1.1

Medical condition in easily understood language

Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Enfermedad Pulmonar Obstructiva Crónica de moderada a
muy grave (EPOC)

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	19.0
E.1.2	Level	LLT
E.1.2	Classification code	10010952
E.1.2	Term	COPD
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

• To assess the effects of BFF MDI relative to FF MDI on COPD
exacerbations
• To assess the effects of BFF MDI relative to FF MDI on lung function

• Evaluar los efectos del ID de BFF en comparación con el ID de FF en las
exacerbaciones de la EPOC
• Evaluar los efectos del ID de BFF en comparación con el ID de FF en la
función pulmonar

E.2.2

Secondary objectives of the trial

• To assess the effects of BFF MDI relative to FF MDI on symptoms of
COPD
• To assess the effects of BFF MDI relative to FF MDI on quality of life
• To assess the effects of BFF MDI on COPD exacerbations

• Evaluar los efectos del ID de BFF en comparación con el ID de FF en los
síntomas de la EPOC
• Evaluar los efectos del ID de BFF en comparación con el ID de FF en la
calidad de vida
• Evaluar los efectos del ID de BFF en las exacerbaciones de la EPOC

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion Criteria:
1. Give their signed written informed consent to participate
2. At least 40 years of age and no older than 80 years of age
3. Moderate to Very Severe COPD patients who are symptomatic
4. Must be receiving one or more inhaled bronchodilators as
maintenance therapy
5. Must have a documented history of COPD exacerbations

Criterios de inclusión:
1. Entregar su documento de consentimiento informado firmado para
participar
2.Tener ≥ 40 y ≤ 80 años
3. EPOC moderada a muy grave en sujetos con sintomatología 4.Deben
estar recibiendo uno o más broncodilatadores inhalados como
tratamiento de mantenimiento
5. Debe tener antecedentes documentados de exacerbaciones de EPOC

E.4

Principal exclusion criteria

Exclusion Criteria:
1.Current diagnosis of asthma
2.COPD due to α1-Antitrypsin Deficiency
3. Known active tuberculosis, lung cancer, cystic fibrosis, and significant
bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery
during the past 6 months.
4. Long-term-oxygen therapy (≥ 15 hours a day).

Criterios de exclusión:
1. Diagnóstico actual de asma
2. EPOC secundaria a un déficit de α1-antitripsina
3. Tuberculosis activa conocida, cáncer de pulmón, fibrosis quística,
bronquiectasias importantes, resección pulmonar o cirugía reductora del
volumen pulmonar durante los 6 últimos meses.
4. Oxigenoterapia crónica (≥ 15 horas/día).

E.5 End points

E.5.1

Primary end point(s)

1. Rate of moderate or severe COPD exacerbations
2. Morning pre-dose trough FEV1

1. Tasa de exacerbaciones moderadas o graves de la EPOC
2.Valor matutino mínimo del FEV1 antes de la dosis

E.5.1.1

Timepoint(s) of evaluation of this end point

1. over 52 Weeks
2. Over 24 weeks

1. Durante 52 semanas
2. Durante 24 semanas

E.5.2

Secondary end point(s)

1. Change from baseline in average daily rescue Ventolin HFA use
2. Transient Dyspnea Index (TDI) focal score
3. Change from baseline in the Exacerbations of Chronic Pulmonary
Disease Tool (EXACT) total score
4. Percentage of subjects achieving an MCID of 4 units or more in Saint
George's Respiratory Questionnaire (SGRQ) total score
5. Time to first moderate or severe COPD exacerbation

1. Variación con respecto al momento basal en el uso promedio de
Ventolin HFA de rescate
2. Puntuación de la escala focal TDI (índice transicional de disnea)
3. Variación con respecto al momento basal en la puntuación total de la
escala EXACT
4. Porcentaje de sujetos que logran una diferencia mínima clínicamente
importante (MCID) of 4 unidades o más en la puntuación total del
cuestionario respiratorio de Saint George (SGRQ)
5. Tiempo transcurrido hasta la primera exacerbación moderada o grave
de la EPOC

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Over 24 weeks
2. Over 24 weeks
3. Over 52 weeks
4. Over 24 weeks
5. At time of occurance

1. Durante 24 semanas
2. Durante 24 semanas
3. Durante 52semanas
4. Durante 24 semanas
5. En el momento del suceso

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

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

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

Argentina

Austria

Belgium

Brazil

Canada

Chile

Denmark

France

Germany

Italy

Mexico

Norway

Peru

Russian Federation

South Africa

Spain

Sweden

United Kingdom

United States

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 visit of last subject.

Última visita del último paciente

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.1.1.1

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:

1233

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

1008

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

180

F.4.2

For a multinational trial

F.4.2.1

In the EEA

851

F.4.2.2

In the whole clinical trial

2241

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)

Subjects who complete the study will be followed up 14 days after with
TC to:
• Collect HCRU information
• Review previously on-going COPD exacerbations
• Review and record AEs/SAEs (if any)
• Review concomitant medications
All subjects who discontinue study treatment prior to 52 weeks will
have their vital status confirmed at 52 weeks post-randomization.There
are no further formal plans for treatment or care after the subject has completed the study for the time being.

Los pac. que terminen el estudio tendrán un seguim. 14 días después
de la TC:
- Recogida de la inform. HCRU.
- Revisón previa de las exacerb. de EPOC en curso.
- Revisión y archivo de AEs/SAEs (si aplica).
- Revisión de la medic. concom.
Todos los pac. que discontinuen el tto del estudio antes de la sem 52
deberán tener su estado vital confirmado en la sem 52 postaleatorización.
No hay más planificación adicional para el tto o
cuidados después de que el pac. haya completado el estudio.

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

2017-02-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-12-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-04-04

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