E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic obstructive pulmonary disease |
Enfermedad Pulmonar Obstructiva Crónica |
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E.1.1.1 | Medical condition in easily understood language |
Chronic obstructive pulmonary disease |
Enfermedad Pulmonar Obstructiva Crónica |
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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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
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 compare the effectiveness and safety of indacaterol with salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone propionate |
Comparar la efectividad y seguridad del tratamiento con indacaterol frente al tratamiento con salmeterol / propionato de fluticasona en pacientes con enfermedad pulmonar obstructiva crónica, quienes estan siendo tratados con salmeterol / propionato de fluticasona a su entrada en el estudio. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of indacaterol 150 ?g o.d. as compared to salmeterol 50 ?g / fluticasone propionate 500 ?g b.i.d. on trough FEV1, standardized FEV1 AUC5 min-4 h, FEV and FVC, Transition Dyspnea Index (TDI), St George?s Respiratory Questionnaire for COPD Patients (SGRQ-C), rescue medication use, safety and exacerbations over the 26 week treatment period. |
Evaluar el efecto de incadaterol 150 ?g o.d. comparado con salmeterol 50 ?g / propionato de fluticasona 500 ?g b.i.d. en el FEV1, FEV1 AUC5 min-4 h estandarizado, FEV y FVC, Indice de Disnea de Transición (TDI), Cuestionario Respiratorio St George para pacientes EPOC (SGRQ-C), uso de la medicación de rescate, seguridad y exacerbaciones a lo largo de las 26 semanas del periodo de tratamiento. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with moderate COPD (Stage II) - Able to perform spirometry assessments - Current or ex-smokers - On treatment with the fixed-dose combination of salmeterol 50 ?g /fluticasone propionate 500 ?g MDDPI b.i.d. for the treatment of COPD for ?3 months directly
Other protocol-defined inclusion/exclusion criteria may apply. |
- Pacientes con EPOC moderada (estadio II) - Capaces de realizar espirometrías - Fumadores o ex-fumadores - En tratamiento con una combinación a dosis fija de salmeterol 50 ?g /propionato de fluticasona 500 ?g MDDPI b.i.d. para el tratamiento de la EPOC por ?3 meses.
Aplican otros criterios de inclusión/exclusión definidos en el protocolo. |
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E.4 | Principal exclusion criteria |
- Having had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the past year. - A history of, or current ECG abnormality. - Asthma
Other protocol-defined inclusion/exclusion criteria may apply. |
- Haber presentado una exacerbación de la EPOC que precisa tratamiento con antibióticos y/o corticoesteroides orales y/o hospitalización durante el año anterior. - Antecedentes de anomalía en el ECG o anomalía actual en el ECG. - Asma
Aplican otros criterios de inclusión/exclusión definidos en el protocolo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To demonstrate non-inferiority of indacaterol (150 ?g o.d.) versus salmeterol 50 ?g /fluticasone propionate 500 ?g b.i.d. with respect to trough FEV1 after 12 weeks of treatment in patients with moderate COPD. Trough FEV1 is the mean of the values assessed at 23 h 10 min and 23 h 45 min following the morning dose after 12 weeks of dosing. |
Demostrar la no inferioridad de indacaterol (150 ?g o.d.) respecto a salmeterol 50 ?g / propionato de fluticasona 500 ?g b.i.d. medida según el volumen espiratorio forzado valle en el primer segundo (FEV1 valle) después de 12 semanas en pacientes con EPOC moderada. Valle se define como la media de las determinaciones de FEV1 a las 23 h 10 min y 23 h 45 min después de la dosis matutina después de 12 semanas de tratamiento. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Trough FEV1 is mean of the values assessed at 23 h 10 min and 23 h 45 min following the morning dose after 26 weeks of dosing. |
FEV valle definido como la media de las determinaciones de FEV1 a las 23 h 10 min y 23 h 45 min después de la dosis matutina después de 26 semanas de tratamiento. |
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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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 72 |
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 |
Belgium |
Brazil |
Colombia |
Italy |
Malaysia |
Mexico |
Netherlands |
Spain |
Switzerland |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
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 the last subject undergoing the trial. |
Última visita del último paciente del ensayo. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |