E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Persistent asthma |
Asma persistente |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 18.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10038738 |
E.1.2 | Term | Respiratory, thoracic and mediastinal disorders |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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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 |
To demonstrate that the addition of FOM to FP therapy is non-inferior to FP therapy alone in terms of the risk of composite serious asthma related events (asthma-related hospitalization, asthma-related intubation, and asthma-related death). |
Demostrar que la adición de FOM al tratamiento con PF es no inferior al tratamiento con PF en monoterapia, en términos del riesgo de acontecimientos graves y compuestos relacionados con el asma (hospitalización relacionada con el asma, intubación relacionada con el asma, muerte relacionada con el asma). |
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E.2.2 | Secondary objectives of the trial |
? to assess the safety each of the individual components of the composite primary endpoint (i.e., asthma-related hospitalization, asthma-related intubation, and asthmarelated death). ? To assess the efficacy of FOM. |
? Asegurar la seguridad de cada uno de los componentes individuales del criterio de valoración principal compuesto (es decir, hospitalización relacionada con el asma, intubación relacionada con el asma, y muerte relacionada con el asma) ? Asegurar la eficacia del FOM |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients eligible for inclusion in this study must fulfill all of the following criteria: ? Written informed consent, and assent if applicable, must be obtained before any assessment is performed. ? Male or female patients 12 years of age and older ? Confirmed diagnosis of persistent asthma, as defined by national and international asthma guidelines (e.g., GINA; NIH; etc.) for at least 1 year prior to study enrollment. ? PEF?50% of predicted normal value. ? Current and appropriate use of treatments for asthma ? Recent asthma exacerbation between 30 days and 12 months prior to randomization ? For women who are not postmenopausal (at least 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use a highly effective method of contraception during the treatment period. |
Para poder ser incluidos en este estudio, los pacientes deben cumplir todos los requisitos que siguen: ? Se debe obtener el consentimiento informado por escrito, y el asentimiento si procede, antes de realizar cualquier evaluación. ? Pacientes de ambos sexos a partir de 12 años de edad. ? Diagnóstico confirmado de asma persistente, según la definición de las directrices internacionales sobre el asma (p. ej., GINA, NIH, etc.) durante al menos 1 año antes de la inscripción en el estudio. ? FEM ? 50 % del valor normal previsto. ? Uso actual y apropiado de tratamientos para el asma ? Exacerbación reciente del asma entre los 30 días y 12 meses previos a la aleatorización. ? Para las mujeres que no son posmenopáusicas ni han sido esterilizadas quirúrgicamente: aceptación de permanecer en abstinencia sexual o usar un método anticonceptivo altamente eficaz durante el periodo de tratamiento. |
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E.4 | Principal exclusion criteria |
Patients fulfilling any of the following criteria are not eligible for inclusion in this study: ? History of life-threatening asthma episode that required intubation and/or was associated with hypercapnia requiring non-invasive ventilatory support. ? Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other respiratory abnormalities other than asthma. ? Current evidence of, or past physician assessment of, chronic bronchitis, emphysema, or chronic obstructive pulmonary disease. ? History of smoking ? 10 pack years. ? Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine. ? Worsening/Unstable asthma within 7 days prior to randomization, ? Any asthma exacerbation requiring systemic (tablets, suspension or injection) corticosteroids within 30 days of randomization or more than 4 separate exacerbations in the 12 months preceding randomization. ? Two or more hospitalizations greater than 24 hours duration for treatment of asthma in the 12 months preceding randomization. ? Use of anti-IgE (e.g., omalizumab) or any other monoclonal antibody, in the 6 months prior to randomization. |
Los pacientes que cumplan alguno de los criterios que siguen no son aptos para la inclusión en este estudio: ? Antecedentes de un episodio de asma potencialmente mortal que requirió la intubación o se asoció con hipercapnia que requirió respiración asistida no invasiva. ? Indicios actuales de neumonía, neumotórax, atelectasia, fibrosis pulmonar, aspergilosis broncopulmonar alérgica, fibrosis quística, displasia broncopulmonar u otras anomalías respiratorias distintas al asma. ? Indicios actuales, o evaluación médica pasada de bronquitis crónica, enfisema o enfermedad pulmonar obstructiva crónica. ? Antecedentes de tabaquismo de ? 10 años-paquete. ? Asma inducido inducida por el ejercicio (como único diagnóstico relacionado con el asma) que no requiere medicamento de control de asma. ? Asma inestable o que empeora en el plazo de los 7 días previos a la aleatorización. ? Cualquier exacerbación del asma que necesite corticoesteroides sistémicos (comprimidos, suspensión o inyección) en los 30 días previos a la aleatorización o más de 4 exacerbaciones separadas en los 12 meses previos a la aleatorización. ? Dos o más hospitalizaciones de más de 24 horas de duración para el tratamiento del asma en los 12 meses previos a la aleatorización. ? Uso de anti-IgE (por ejemplo, omalizumab) o cualquier otro anticuerpo monoclonal, en los 6 meses previos a la aleatorización. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To demonstrate that the addition of FOM to FP therapy is non-inferior to FP therapy alone in terms of the risk of composite serious asthma related events (asthma-related hospitalization, asthma-related intubation, and asthma-related death). |
? Asegurar la seguridad de cada uno de los componentes individuales del criterio de valoración principal compuesto (es decir, hospitalización relacionada con el asma, intubación relacionada con el asma, y muerte relacionada con el asma) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the 26 week treatment period (182 days) + 7 days of follow up period. |
A través del tratamiento de l periodo de 26 semanas (182 dias) + 7 dias del periodo de seguimiento |
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E.5.2 | Secondary end point(s) |
? To assess the safety each of the individual components of the composite primary endpoint (i.e., asthma-related hospitalization, asthma-related intubation, and asthma related death). ? To assess the efficacy of FOM. |
? Asegurar la seguridad de cada uno de los componentes individuales del criterio de valoración principal compuesto (es decir, hospitalización relacionada con el asma, intubación relacionada con el asma, y muerte relacionada con el asma) ? Asegurar la eficacia del FOM |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Throughout the 26 week treatment period (182 days) + 7 days of follow up period. |
A través del tratamiento de l periodo de 26 semanas (182 dias) + 7 dias del periodo de seguimiento |
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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 | No |
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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
FOM+ Placebo frente a FOM+FP |
FOM+ Placebo vs FOM +FP |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 250 |
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 |
Brazil |
Bulgaria |
Canada |
Chile |
Colombia |
Czech Republic |
Denmark |
Estonia |
European Union |
Finland |
France |
Germany |
Greece |
Hungary |
India |
Indonesia |
Italy |
Korea, Republic of |
Latvia |
Lithuania |
Malaysia |
Mexico |
New Zealand |
Panama |
Philippines |
Poland |
Portugal |
Romania |
Russian Federation |
Serbia |
Singapore |
Slovakia |
South Africa |
Spain |
Sweden |
Taiwan |
Thailand |
Turkey |
Ukraine |
United Kingdom |
United States |
Vietnam |
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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
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LVLS + 7 days follow up |
última visita del último paciente + 7 días de seguimiento |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial months | 11 |