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< Back to search results Summary EudraCT Number:
2011-001644-29
Sponsor's Protocol Code Number:
SAS115359
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:
2012-01-11
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 A. Protocol Information A.1
Member State Concerned
Spain - AEMPS
A.2
EudraCT number
2011-001644-29
A.3
Full title of the trial
SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects with Asthma. SAS115359, un estudio de seguridad y eficacia de una combinación de propionato de fluticasona/salmeterol inhalada frente a propionato de fluticasona inhalado en el tratamiento de sujetos adolescentes y adultos con asma.
A.3.1
Title of the trial for lay people, in easily understood, i.e. nonA 6-month study to assess the safety and benefit of inhaled fluticasone propionate/salmeterol combination compared with inhaled technical, language fluticasone propionate in the treatment of adolescents (12 years and over) and adults with asthma. Un estudio de 6 meses para determinar la seguridad y beneficio de una combinación de propionato de fluticasona/salmeterol inhalada comparada con propionato de fluticasona inhalado en el tratamiento de adolescentes (12 años y mayores) y adultos con asma.
A.3.2
Name or abbreviated title of the trial where available
A.4.1
Sponsor's protocol code number
SAS115359
A.7
Trial is part of a Paediatric Investigation Plan
No
A.8
EMA Decision number of Paediatric Investigation Plan
AUSTRI
B. Sponsor Information B.Sponsor: 1 B.1.1
Name of Sponsor
GlaxoSmithKline Research & Development Limited
B.1.3.4
Country
United Kingdom
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
GlaxoSmithKline Research & Development
B.4.2
Country
United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial B.5.1
Name of organisation
GlaxoSmithKline Research & Development
B.5.2
Functional name of contact point
GSK Clinical Support HelpDesk
B.5.3
Address:
B.5.3.1
Street Address
Iron Bridge Rd,
B.5.3.2
Town/ city
Stockley Park West, Uxbridge
B.5.3.3
Post code
UB11 1BU
B.5.3.4
Country
United Kingdom
B.5.4
Telephone number
+4402089904466
B.5.5
Fax number
+4402089904968
B.5.6
E-mail
[email protected]
D. IMP Identification D.IMP: 1 D.1.2 and IMP Role D.1.3
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
Flixotide Accuhaler 100 micrograms
D.2.1.1.2
Name of the Marketing Authorisation holder
Glaxo Wellcome UK Limited, trading as Allen & Hanburys Stockley Park West
D.2.1.2
Country which granted the Marketing Authorisation
United Kingdom
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.3.2
Product code
FP 100 mcg
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.3.9.1
CAS number
80474-14-2
D.3.9.3
Other descriptive name
FLUTICASONE PROPIONATE
D.3.9.4
EV Substance Code
SUB02241MIG
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
100
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 No than Advanced Therapy IMP (ATIMP) 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, No immune serum)
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 IMP Role D.1.3
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
Seretide 100 Accuhaler
D.2.1.1.2
Name of the Marketing Authorisation holder
Glaxo Wellcome UK Limited, trading as Allen & Hanburys Stockley Park West
D.2.1.2
Country which granted the Marketing Authorisation
United Kingdom
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.3.2
Product code
SFC 50/100 mcg
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.3.9.1
CAS number
80474-14-2
D.3.9.3
Other descriptive name
FLUTICASONE PROPIONATE
D.3.9.4
EV Substance Code
SUB02241MIG
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
100
D.3.8 to D.3.10 IMP Identification Details (Active Substances) D.3.9.1
CAS number
94749-08-3
D.3.9.3
Other descriptive name
SALMETEROL XINAFOATE
D.3.9.4
EV Substance Code
SUB04314MIG
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
50
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 No than Advanced Therapy IMP (ATIMP) 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, No immune serum)
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 IMP Role D.1.3
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
Flixotide Accuhaler 250 micrograms
D.2.1.1.2
Name of the Marketing Authorisation holder
Glaxo Wellcome UK Limited, trading as Allen & Hanburys Stockley Park West
D.2.1.2
Country which granted the Marketing Authorisation
United Kingdom
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.3.2
Product code
FP 250 mcg
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.3.9.1
CAS number
80474-14-2
D.3.9.3
Other descriptive name
FLUTICASONE PROPIONATE
D.3.9.4
EV Substance Code
SUB02241MIG
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
250
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 No than Advanced Therapy IMP (ATIMP) 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, No immune serum)
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 IMP Role D.1.3
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
Seretide 250 Accuhaler
D.2.1.1.2
Name of the Marketing Authorisation holder
Glaxo Wellcome UK Limited, trading as Allen & Hanburys Stockley Park West
D.2.1.2
Country which granted the Marketing Authorisation
United Kingdom
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.3.2
Product code
SFC 50/250 mcg
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.3.9.1
CAS number
80474-14-2
D.3.9.3
Other descriptive name
FLUTICASONE PROPIONATE
D.3.9.4
EV Substance Code
SUB02241MIG
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
250
D.3.8 to D.3.10 IMP Identification Details (Active Substances) D.3.9.1
CAS number
94749-08-3
D.3.9.3
Other descriptive name
SALMETEROL XINAFOATE
D.3.9.4
EV Substance Code
SUB04314MIG
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
50
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 No than Advanced Therapy IMP (ATIMP) 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, No immune serum)
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 IMP Role D.1.3
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
Flixotide Accuhaler 500 micrograms
D.2.1.1.2
Name of the Marketing Authorisation holder
Glaxo Wellcome UK Limited, trading as Allen & Hanburys Stockley Park West
D.2.1.2
Country which granted the Marketing Authorisation
United Kingdom
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.3.2
Product code
FP 500 mcg
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.3.9.1
CAS number
80474-14-2
D.3.9.3
Other descriptive name
FLUTICASONE PROPIONATE
D.3.9.4
EV Substance Code
SUB02241MIG
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
500
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 No than Advanced Therapy IMP (ATIMP) 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, No immune serum)
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 IMP Role D.1.3
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
Seretide 500 Accuhaler
D.2.1.1.2
Name of the Marketing Authorisation holder
Glaxo Wellcome UK Limited, trading as Allen & Hanburys Stockley Park West
D.2.1.2
Country which granted the Marketing Authorisation
United Kingdom
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.3.2
Product code
SFC 50/500 mcg
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.3.9.1
CAS number
80474-14-2
D.3.9.3
Other descriptive name
FLUTICASONE PROPIONATE
D.3.9.4
EV Substance Code
SUB02241MIG
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
500
D.3.8 to D.3.10 IMP Identification Details (Active Substances) D.3.9.1
CAS number
94749-08-3
D.3.9.3
Other descriptive name
SALMETEROL XINAFOATE
D.3.9.4
EV Substance Code
SUB04314MIG
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
50
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 No than Advanced Therapy IMP (ATIMP) 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, No immune serum)
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 Asma
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
14.1
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
No
E.2 Objective of the trial E.2.1
Main objective of the trial
The primary objective of the study is to evaluate whether the addition of LABA to ICS therapy (FSC) is non-inferior to ICS therapy alone (FP) in terms of the risk of serious asthma related events (asthma-related hospitalization, endotracheal intubation, and death). El objetivo principal del estudio es evaluar si la adición de LABA a la terapia con ICS (FSC) no es inferior a la terapia con ICS solamente (FP) en términos de riesgo de eventos graves relacionados con el asma (hospitalización, intubación endotraqueal y muerte relacionadas con el asma).
E.2.2
Secondary objectives of the trial
A secondary objective of the study is to evaluate whether the addition of LABA to ICS therapy (FSC) is superior to ICS therapy alone (FP) in terms of measures of efficacy. El objetivo secundario del estudio es evaluar si la adición de LABA a la terapia con ICS (FSC) es superior a la terapia con ICS solamente (FP) en términos de medidas de eficacia.
E.2.3
Trial contains a sub-study
E.3
Principal inclusion criteria
No 1. Informed Consent: - The subject and/or the subject?s legal guardian (if applicable) must provide written informed assent/consent to take part in the study. - Subjects and/or their legal guardians (if applicable) understand that they must comply with study treatment and study assessments including recording of daily information regarding their asthma status and attend scheduled study visits, and be accessible by telephone. 2. Subject: 12 years of age and older. 3. Gender: Male or female. 4. Asthma Diagnosis: Persistent asthma, defined by national and international asthma guidelines for at least 1 year prior to study enrolment. If the subject is naïve to the study site, the diagnosis of asthma must be confirmed by subject history. 5. PEF: A clinic PEF>/=50% of predicted normal value. Percent predicted PEF values must be calculated using NHANES III with relevant equations that adjust for race and national origin. 6. Current Asthma Therapy: Subjects must be appropriately using one of the following for the treatment of asthma and meet the criteria outlined below: - ICS or ICS with one or more adjunctive therapies (LABA, LTRA or theophylline) for at least 4 weeks prior to randomization (see Table 1: for ICS dose equivalents). Any subject maintained on a stable high dose ICS or stable high dose ICS with one or more adjunctive therapies (LABA, LTRA or theophylline) must have an ACQ-6 < 1.5 (i.e., controlled) at Visit 1. - Leukotriene receptor antagonist (i.e. LTRAs such as montelukast, zafirlukast, or pranlukast) OR theophylline as monotherapy at a stable dose for at least 4 weeks prior to randomization. Subjects on LTRAs or theophylline are eligible only if they record an ACQ-6 score of >/= 1.5 (i.e. not well controlled) and in the Investigator?s clinical judgement, the subject?s asthma severity could justify treatment with ICS or ICS + LABA. - Daily rescue medication (e.g., albuterol/salbutamol or other inhaled short-acting beta-agonist used to treat acute asthma) in the 4 weeks prior to randomization Subjects on daily rescue medication are eligible only if they record an ACQ-6 score of >/= 1.5 and in the investigator?s clinical judgement, the subject?s asthma severity could justify treatment with ICS or ICS + LABA. 7. Exacerbation History: Subject must have a history of one of the following: - at least one asthma exacerbation requiring treatment with a systemic corticosteroid (tablets, suspension, or injection) between 30 days and 12 months prior to randomization OR - an asthma-related hospitalization (defined as an inpatient stay or a 24-hour stay in an observation area in an emergency room or other equivalent facility) between 30 days and 12 months prior to randomization 8. Questionnaire: Ability to answer questions regarding asthma status and quality of life and ability to use a daily electronic data capture system. 9. Inhaler Usage: Ability to demonstrate proper use of a metered-dose inhaler and dry powder inhaler (DPI) device. 1. Consentimiento informado: - El sujeto y/o tutor legal del sujeto (si corresponde) debe proporcionar un consentimiento/aprobación informados por escrito para participar en el estudio. - Los sujetos y/o sus tutores legales (si corresponde) entienden que deben cumplir con el tratamiento y las evaluaciones del estudio, que incluyen el registro de información diaria sobre el estado del asma y la asistencia a las visitas programadas del estudio, y estar disponibles por teléfono. 2. Sujeto: 12 años de edad o más. 3. Sexo: Hombre o mujer. 4. Diagnóstico del asma: Asma persistente, definida por las pautas internacionales y nacionales del asma durante al menos un año antes del estudio. Si el sujeto no tuvo tratamiento previo en el centro de estudio, el diagnóstico de asma debe confirmarse mediante los antecedentes del paciente. 5. PEF: Un PEF clínico del >/=50% del valor de referencia normal. Los porcentajes de los valores previstos de PEF deben calcularse con NHANES III, con las ecuaciones pertinentes que se ajustan a la raza y origen nacional. 6. Terapia actual del asma: Los sujetos deben estar usando de forma adecuada uno de los siguientes medicamentos para el tratamiento del asma y responder a los criterios descritos a continuación: - ICS o ICS con una o más terapias complementarias (LABA, LTRA o teofilina) durante al menos 4 semanas antes de la aleatorización (consulte la Tabla 1: para obtener los equivalentes de dosis de ICS). Cualquier sujeto que se mantiene en una dosis de ICS estable y alta o una dosis de ICS estable y alta con una o más terapias complementarias (LABA, LTRA o teofilina) debe obtener un ACQ-6 /= 1,5 (es decir, no bien controlado) y, según el criterio clínico del investigador, la gravedad del asma en el sujeto podría justificar el tratamiento con ICS o ICS + LABA. - Los medicamentos de rescate diarios (p. ej.,albuterol/salbutamol u otro beta-agonista de acción corta inhalado, utilizado para tratar el asma agudo) en las 4 semanas anteriores a la aleatorización. Los sujetos que toman medicamentos de rescate diarios son elegibles solamente si registran una calificación en el ACQ-6 de 1,5 y, >/= según el criterio clínico del investigador, la gravedad del asma en el sujeto podría justificar el tratamiento con ICS o ICS + LABA. 7. Antecedentes de exacerbación: el sujeto debe tener antecedentes de uno de los siguientes eventos: - al menos una exacerbación de asma que haya requerido tratamiento con corticosteroides sistémicos (comprimidos, suspensión o inyección) entre 30 días y 12 meses antes de la aleatorización; O bien, - una hospitalización relacionada con el asma (definida como una internación del paciente o una estancia de 24 horas en un área de observación en un servicio de urgencias o una instalación equivalente) entre 30 días y 12 meses antes de la aleatorización. 8. Cuestionario: capacidad para responder preguntas acerca del estado del asma y la calidad de vida y capacidad para utilizar un sistema electrónico de captura de datos diaria. 9. Uso del inhalador: capacidad para demostrar el uso apropiado de un inhalador con dosis medida y dispositivo inhalador de polvo seco (DPI).
E.4
Principal exclusion criteria
1. History of Life-Threatening Asthma: Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support. 2. Concurrent Respiratory Disease: Subjects with current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other respiratory abnormalities other than asthma. 3. Chronic Obstructive Pulmonary Disease: chronic bronchitis, emphysema, or chronic obstructive pulmonary disease. 4. Tobacco Use. 5. Exercise-induced Asthma: Subjects with exercise induced asthma not requiring daily asthma control medicine. 6. Respiratory Infection. 7. Unstable Asthma Status: Subjects must not meet the following unstable asthma severity criteria within 7-days prior to randomization:- Asthma symptoms that persisted throughout the day on 2 consecutive days;- Nighttime awakening due to asthma >/=3 times;- Albuterol/salbutamol (or equivalent) use for the acute worsening of asthma symptoms >8 puffs a day over 2 consecutive days or >/=25 puffs in one day;- Asthma symptoms so severe that the subject was limited in their ability to perform normal daily activity on any 1 day 8. Asthma Exacerbation: An asthma exacerbation requiring systemic corticosteroids within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization. 9. Asthma Hospitalizations: More than 2 hospitalizations for greater than 24 hours duration for treatment of asthma in the 12 months preceding randomization. 10. Pregnancy and Lactation: Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation. All females of childbearing potential must have a negative urine pregnancy test result prior to randomization to continue in the study. 11. Concurrent Diseases/Abnormalities: A subject with any known, pre-existing, clinically significant condition, disorder or disease of any body or organ system that is uncontrolled with standard treatment and that would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition, disorder or disease exacerbated during the study. 12. Investigational Medications: A subject who has participated in an interventional study, or used any investigational drug for any disease state, within 30 days prior to randomization. 13. Participation in a Concurrent LABA Safety Study: A subject who has taken at least one dose of study medication in one of the other sponsored studies, being conducted concurrently, to investigate the safety of the addition of LABA to ICS. 14. Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any corticosteroid therapy or any component of these combination medications including severe milk protein hypersensitivity. 15. Monoclonal Antibody Use: Anti-IgE, or any other monoclonal antibody, for any reason in the 6-months prior to randomization. 16. Concomitant Medications: Use of beta-blockers within 1 day prior to first dose of study medication. Use of ICS, LABA, ICS+LABA, LTRAs, leukotriene modifiers, anticholinergics, or theophylline must be discontinued prior to the first dose of study medication. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John?s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives prior to the first dose of study medication, unless in the opinion of the Investigator and study Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. 17. Potent Cytochrome P450 3A4 (CYP3A4) inhibitors: A subject who has received potent CYP34A inhibitor within 4 weeks of randomization. 18. Risk of Non-Compliance: Subjects who are unable to follow study instructions such as dosing directions or use of the DISKUS/ACCUHALER or metered dose inhaler. 19. Child in Care. 20. Affiliation with Investigator?s Site. 1. Antecedentes de asma con riesgo de vida: definidos para este protocolo como un episodio de asma que requirió intubación y/o se asoció con hipercapnia que requirió apoyo ventilatorio no invasivo. 2. Enfermedad respiratoria concurrente: sujetos con evidencia actual de neumonía, neumotórax, atelectasia, enfermedad fibrótica pulmonar, aspergilosis broncopulmonar alérgica, fibrosis quística, displasia broncopulmonar u otros trastornos respiratorios excepto asma. 3. EPOC: sujetos con evidencia actual de, o a quienes alguna vez les ha dicho un médico que tienen, bronquitis crónica, enfisema o enfermedad pulmonar obstructiva crónica. 4. Consumo de tabaco. 5. Asma inducida por el ejercicio: sujetos con asma inducida por el ejercicio que no requieren medicamentos diarios de control del asma. 6. Infección de las vías respiratorias. 7. Estado de asma inestable: los sujetos no deben responder a los siguientes criterios de gravedad de asma inestable dentro de los 7 días previos a la aleatorización:- síntomas del asma que persistieron todo el día durante 2 días consecutivos;- despertar nocturno debido al asma >/=3 veces;- uso de albuterol/salbutamol (o equivalente) por empeoramiento agudo de los síntomas de asma >8 dosis al día durante 2 días consecutivos o >/=25 inhalaciones en un día;- los síntomas de asma son tan graves que la capacidad del sujeto para realizar sus actividades diarias normales 1 día cualquiera era limitada. 8. Exacerbación del asma: una exacerbación de asma que requiere corticosteroides sistémicos dentro las 4 semanas de la aleatorización o más de 4 exacerbaciones por separado en los 12 meses anteriores a la aleatorización. 9. Hospitalizaciones por asma: más de 2 hospitalizaciones durante más de 24 horas para el tratamiento del asma en los 12 meses anteriores a la aleatorización. 10. Embarazo y lactancia: las mujeres no deben ser inscritas si están embarazadas o en período de lactancia o si planean quedar embarazadas durante el tiempo de participación en el estudio. Todas las mujeres en edad fértil deben tener un resultado negativo en la prueba de embarazo en orina antes de la aleatorización para continuar en el estudio. 11. Enfermedades concurrentes/anomalías: un sujeto con cualquier afección, trastorno o enfermedad conocida, preexistente, clínicamente significativa de cualquier sistema de órganos o del cuerpo que no está controlada con el tratamiento estándar y que pondría la seguridad del sujeto en riesgo durante su participación en el estudio o que podría confundir la interpretación de los resultados si la afección, el trastorno o la enfermedad se agrava durante el estudio. 12. Medicamentos experimentales: un sujeto que ha participado en un estudio de intervención o que utilizó cualquier medicamento en investigación para cualquier estado de la enfermedad, dentro de los 30 días anteriores a la aleatorización. 13. Participación en un estudio de seguridad concurrente de LABA: un sujeto que ha tomado al menos una dosis del medicamento del estudio en uno de los otros estudios patrocinados, que se están llevando a cabo al mismo tiempo, para investigar la seguridad de la adición de LABA a ICS. 14. Alergia a medicamentos: cualquier reacción adversa, incluso hipersensibilidad inmediata o retardada a cualquier beta2 agonista, medicamentos simpaticomiméticos o cualquier otra terapia con corticosteroides o cualquiera de los componentes de estas combinaciones de medicamentos, incluso la hipersensibilidad grave a la proteína de la leche. 15. Uso de anticuerpos monoclonales: anti-IgE o cualquier otro anticuerpo monoclonal, por cualquier motivo en los 6 meses anteriores a la aleatorización. 16. Medicamentos concurrentes: el uso de bloqueadores beta dentro del día anterior a la primera dosis del medicamento del estudio. El uso de ICS, LABA, ICS+LABA, LTRA, modificadores de leucotrieno, anticolinérgicos o teofilina debe suspenderse antes de la primera dosis del medicamento del estudio. El uso de medicamentos recetados o de venta libre, que incluyen vitaminas, hierbas y suplementos dietéticos (incluso la hierba de San Juan) dentro de los 7 días (o 14 días si el medicamento es un inductor potencial de enzimas) o 5 vidas medias antes de la primera dosis del medicamento del estudio, a menos que, a criterio del investigador y el monitor médico del estudio, el medicamento no interfiera en los procedimientos del estudio ni comprometa la seguridad del sujeto. 17. Inhibidores potentes del citocromo P450 3A4 (CYP3A4): un sujeto que ha recibido un inhibidor potente CYP34A en las 4 semanas anteriores a la aleatorización. 18. Riesgo de incumplimiento: los sujetos que no son capaces de seguir las instrucciones del estudio, como las instrucciones de dosificación o de cómo usar el DISKUS/ACCUHALER o el inhalador de dosis medida. 19. Niño a cargo del estado. 20. Vínculo con el centro del investigador.
E.5 End points E.5.1
Primary end point(s)
The primary safety endpoint is the number of subjects experiencing an event in the composite endpoint of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death) over the 26-week study period. The primary efficacy endpoint is severe asthma exacerbations. El criterio de valoración principal de seguridad es la cantidad de sujetos que experimentan un evento en el criterio de valoración combinado de resultados de asma grave (es decir, hospitalización relacionada con el asma, intubación endotraqueal relacionada con el asma y muerte relacionada con el asma) durante un período de 26 semanas. El criterio de valoración principal de eficacia son las exacerbaciones de asma graves.
E.5.1.1
Timepoint(s) of evaluation of this end point
Within the 6 months post-randomization Dentro de los 6 meses posteriores a la aleatorización
E.5.2
Secondary end point(s)
Secondary safety endpoints include the individual component endpoints of asthmarelated hospitalization, endotracheal intubation, and death, and withdrawals from the study treatment due to asthma exacerbation. The secondary efficacy endpoints is albuterol/salbutamol use. Los criterios de valoración secundarios de seguridad incluyen los criterios de valoración de los componentes individuales de la hospitalización, intubación endotraqueal y muerte relacionadas con asma y el abandono del tratamiento del estudio debido a la exacerbación del asma. El criterio de valoración secundario de eficacia es el uso de albuterol/salbutamol.
E.5.2.1
Timepoint(s) of evaluation of this end point
Entire treatment period (up to 6 months) Periodo completo de tratamiento (hasta 6 meses)
E.6 and E.7 Scope of the trial E.6
Scope of the trial
E.6.1
Diagnosis
No
E.6.2
Prophylaxis
No
E.6.3
Therapy
Yes
E.6.4
Safety
Yes
E.6.5
Efficacy
Yes
E.6.6
Pharmacokinetic
No
E.6.7
Pharmacodynamic
No
E.6.8
Bioequivalence
No
E.6.9
Dose response
No
E.6.10
Pharmacogenetic
Yes
E.6.11
Pharmacogenomic
No
E.6.12
Pharmacoeconomic
No
E.6.13
Others
No
E.7
Trial type and phase
E.7.1
Human pharmacology (Phase I)
No
E.7.1.1
First administration to humans
No
E.7.1.2
Bioequivalence study
No
E.7.1.3
Other
No
E.7.1.3.1 Other trial type description E.7.2
Therapeutic exploratory (Phase II)
No
E.7.3
Therapeutic confirmatory (Phase III)
No
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
No
E.8.1.3
Single blind
No
E.8.1.4
Double blind
Yes
E.8.1.5
Parallel group
Yes
E.8.1.6
Cross over
No
E.8.1.7
Other
Yes
E.8.1.7.1 Other trial design description
stratified
E.8.2
Comparator of controlled trial
E.8.2.1
Other medicinal product(s)
Yes
E.8.2.2
Placebo
No
E.8.2.3
Other
No
E.8.2.4
Number of treatment arms in the trial
6
E.8.3
The trial involves single site in the Member State concerned No
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
19
E.8.5
The trial involves multiple Member States
Yes
E.8.5.1
Number of sites anticipated in the EEA
314
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
No
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 Australia Austria Belgium Brazil Canada Chile China Colombia Croatia European Union Hong Kong India Indonesia Israel Japan Macedonia, the former Yugoslav Republic of Malaysia New Zealand Peru Russian Federation South Africa Taiwan Thailand Turkey 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 post-treatment follow up phone contact last subject Último contacto telefónico con el último paciente en fase de seguimiento post-tratamiento.
E.8.9 Initial estimate of the duration of the trial E.8.9.1
In the Member State concerned years
4
E.8.9.1
In the Member State concerned months
5
E.8.9.1
In the Member State concerned days
0
E.8.9.2
In all countries concerned by the trial years
4
E.8.9.2
In all countries concerned by the trial months
8
E.8.9.2
In all countries concerned by the trial days
0
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:
1400
F.1.1.1
In Utero
No
F.1.1.2
Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3
Newborns (0-27 days)
No
F.1.1.4
Infants and toddlers (28 days-23 months)
No
F.1.1.5
Children (2-11years)
No
F.1.1.6
Adolescents (12-17 years)
Yes
F.1.1.6.1 Number of subjects for this age range:
1400
F.1.2
Adults (18-64 years)
Yes
F.1.2.1
Number of subjects for this age range:
9798
F.1.3
Elderly (>=65 years)
Yes
F.1.3.1
Number of subjects for this age range:
466
F.2 Gender F.2.1
Female
Yes
F.2.2
Male
Yes
F.3 Group of trial subjects F.3.1
Healthy volunteers
No
F.3.2
Patients
Yes
F.3.3
Specific vulnerable populations
Yes
F.3.3.1
Women of childbearing potential not using contraception For Yes clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-01-11.
F.3.3.2
Women of child-bearing potential using contraception
Yes
F.3.3.3
Pregnant women
No
F.3.3.4
Nursing women
No
F.3.3.5
Emergency situation
No
F.3.3.6
Subjects incapable of giving consent personally
No
F.3.3.7
Others
No
F.4 Planned number of subjects to be included F.4.1
In the member state
190
F.4.2
For a multinational trial
F.4.2.1
In the EEA
2900
F.4.2.2
In the whole clinical trial
11664
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)
No post-study medication will be provided. The investigator is responsible for ensuring that consideration has been given to the post-study care of the patient's medical condition. No se facilitará medicación tras la finalización del estudio. El investigador es el responsable de asegurar que se ha considerado el tratamiento post-estudio para la enfermedad del paciente.
G. Investigator Networks to be involved in the Trial N. Review by the Competent Authority or Ethics Committee in the country concerned N.
Competent Authority Decision
Authorised
N.
Date of Competent Authority Decision
2012-02-15
N.
Ethics Committee Opinion of the trial application
Favourable
N.
Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.
Date of Ethics Committee Opinion
2012-02-07
P. End of Trial P.
End of Trial Status
Completed
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