E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Severe Asthma |
Asma Severa |
|
E.1.1.1 | Medical condition in easily understood language |
Severe Asthma |
Asma Severa |
|
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 | 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 |
To evaluate effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. Safety will also be assessed. Comparison will be to placebo. |
Evaluar el efecto en la reducción de la tasa de exacerbaciones asmáticas graves con diferentes niveles de dosis de QGE031 en pacientes asmáticos que no estén adecuadamente controlados con corticosteroides inhalados (CI) más medicacion agonista beta-2 de larga duracion (LABA) con o sin corticosteroides orales (CO). Se evaluará también la seguridad. Se comparara con placebo. |
|
E.2.2 | Secondary objectives of the trial |
1. To evaluate the efficacy of QGE031 compared to placebo on top of SoC in patients (all: atopic and non-atopic) with asthma not adequately controlled by medium- or high-dose ICS plus LABA with or without OCS on the reduction in rate of severe asthma exacerbations during 52 weeks of treatment. 2. To evaluate the efficacy of QGE031 compared to placebo on top of SoC in patients (non-atopic) with asthma not adequately controlled by medium- or high-dose ICS plus LABA with or without OCS on the reduction in rate of severe asthma exacerbations during 52 weeks of treatment. |
1. Evaluar la eficacia de QGE031 en comparación con placebo, además del tratamiento estándar, en todos los pacientes con asma (atópicos y no atópicos) que no estén adecuadamente controlados con dosis medias o altas de CI más LABA con o sin CO en la reducción de la tasa de exacerbaciones asmáticas graves durante 52 semanas de tratamiento. 2. Evaluar la eficacia de QGE031 en comparación con placebo, además del tratamiento estándar, en pacientes no atópicos con asma que no estén adecuadamente controlados con dosis medias o altas de CI más LABA con o sin CO en la reducción de la tasa de exacerbaciones asmáticas graves durante 52 semanas de tratamiento. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A diagnosis of allergic asthma, uncontrolled on current medication. ?History of at least 2 asthma exacerbations during the last 1 year ?Forced Expiratory Volume in one second (FEV1) of ? 40% and ? 80% of the predicted normal value; reversibility following administration of bronchodilator. |
Diagnóstico de asma alérgica no controlada con la medicación actual. - Antecedentes de al menos dos exacerbaciones asmáticas durante los 12 meses anteriores - Volumen Expiratorio Forzado en un segundo (FEV1) ? 40% y ? 80% del valor normal teórico del paciente ; reversibilidad tras la administracion de un broncodilatador. |
|
E.4 | Principal exclusion criteria |
?Use of tobacco products within the previous 6 months (Social occasional smokers may be included). ?Recent asthma attack/exacerbation or asthma worsening/ respiratory infection. |
- Uso de productos de tabaco durante los 6 meses anteriores (fumadores ocasionales podrán ser incluidos) - Reciente ataque de asma/exacerbación o empeoramiento del asma / infección respiratoria. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of exacerbations within 52 weeks in atopic patients |
Número de exacerbaciones durante 52 semanas en pacientes atopicos. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Number of exacerbation in all patients (atopic and non-atopic) Number of exacerbations in non-atopic patients |
Número de exacerbaciones en todos los pacientes (atopicos y no atopicos). Número de exacerbaciones en pacientes no atopicos. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 94 |
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 |
Belgium |
Brazil |
Canada |
Chile |
Colombia |
Czech Republic |
Denmark |
France |
Germany |
Greece |
Guatemala |
Hungary |
India |
Ireland |
Israel |
Italy |
Japan |
Korea, Republic of |
Mexico |
Netherlands |
Norway |
Panama |
Peru |
Poland |
Russian Federation |
Slovakia |
Slovenia |
South Africa |
Spain |
Sweden |
Switzerland |
Taiwan |
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
|
Completion of the study in general will be when all randomized have completed the 20 weeks follow-up period (Visit 303) or have prematurely withdrawn. |
El ensayo en general se completará cuando todos los pacientes randomizados hayan realizado las 20 semanas del periodo de seguimiento (Visita 303) o hayan discontinuado prematuramente. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |