E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Enfermedad Pulmonar Obstructiva Crónica (EPOC) Chronic Obstructive Pulmonary Disease (COPD) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
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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 |
Determinar el efecto de teofilina a dosis bajas añadido al tratamiento inhalado combinado (ICS+LABA) sobre la tasa de exacerbaciones, definida por un incremento de los síntomas que requiere un cambio en la medicación (antibióticos y/o glucocorticoides sistémicos) u hospitalización.
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E.2.2 | Secondary objectives of the trial |
a. Determinar el tiempo hasta la primera exacerbación en el grupo de teofilina comparado con placebo b. Comparar el número de hospitalizaciones en el grupo de teofilina vs. placebo c. Evaluar el efecto de la teofilina sobre la actividad de histona deacetilasa en células mononucleares de sangre y esputo d. Valorar las diferencias en calidad de vida, medida por el HRQL (St. George´s Respiratory Questionnaire) en ambos grupos. e. Investigar los efectos que la adicion de teofilina a dosis bajas pueda tener sobre la función pulmonar y el índice de BODE
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Los pacientes con diagnóstico de EPOC severo reclutados durante una hospitalización por una exacerbación de EPOC que cumplan los criterios de inclusión (Edad > 45 años, historia tabáquica de > 10 paquetes-año, diagnóstico de EPOC en estadíos III o IV de la GOLD (FEV1/FVC < 0.7 y post-BD FEV1 < 50% del valor de referencia))
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E.4 | Principal exclusion criteria |
Criterios de exclusión: Presencia de otra enfermedad inflamatoria crónica asociada o tumoral, diagnóstico confirmado de asma, pacientes con intolerancia conocida a teofilina. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Tasa de exacerbaciones, definida por un incremento de los síntomas que requiere un cambio en la medicación (antibióticos y/o glucocorticoides sistémicos) u hospitalización. |
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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 | 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 | 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) | 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 | 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.8.3 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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Criterios de retirada de los sujetos del estudio: incumplimiento terapéutico, persistencia de nauseas y vómitos tras 48 horas de tratamiento, incapacidad para realizar visitas 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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |