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 | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
E.1.2 | System Organ Class | 100000004855 |
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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 |
The overall objective of the trial is to compare the lung function profile of 2 doses of once daily treatment with tiotropium+olodaterol FDC delivered by the RESPIMAT with the lung function profile of 2 doses of twice daily treatment with fluticasone propionate+salmeterol FDC delivered by the Acuhaler® after 6 weeks of treatment. |
El objetivo de este estudio es comparar el perfil de función pulmonar de un tratamiento una vez al día con tiotropio + olodaterol FDC administrado mediante el RESPIMAT con el perfil de función pulmonar de un tratamiento dos veces al día con propionato de fluticasona + salmeterol FDC administrado mediante el inhalador Accuhaler® tras 6 semanas de tratamiento. FDC: Fixed Dose Combination (Combinación a dosis fija) |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Diagnosis of chronic obstructive pulmonary disease 2. Relatively stable airway obstruction with a post-bronchodilator 30% </= Forced Expiratory Volume in 1 second (FEV1)<80% of predicted normal and a post-bronchodilator FEV1/(Forced Vital Capacity)FVC <70% 3. Male or female patients, 40 years of age or older 4. Smoking history of more than 10 pack years 5. Ability to perform technically acceptable pulmonary function tests and maintain records 6. Ability to inhale medication in a competent manner from the RESPIMAT Inhaler, Accuhaler and from a metered dose inhaler (MDI) |
1. Diagnóstico de enfermedad pulmonar obstructiva crónica 2. Pacientes con un valor post-broncodilatador del 30 % <= FEV1 < 80 % del valor normal previsto; y un valor post-broncodilatador FEV1/FVC < 70 % en la Visita 1 3. Pacientes de ambos sexos de 40 años en adelante. 4. Los pacientes deberán ser fumadores o ex-fumadores con antecedentes de tabaquismo de más de 10 años-paquete. 5. Los pacientes deberán ser capaces de realizar pruebas de la función pulmonar técnicamente aceptables y mantener registros 6. Los pacientes deben ser capaces de inhalar la medicación de modo competente del inhalador RESPIMAT, un inhalador con válvula dosificadora (MDI) y del Accuhaler ® |
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E.4 | Principal exclusion criteria |
1. Significant disease other than COPD 2. COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months. 3. Clinically relevant abnormal lab values 4. History of asthma 5. Diagnosis of thyrotoxicosis 6. Diagnosis of paroxysmal tachycardia 7.History of myocardial infarction 8. Unstable or life-threatening cardiac arrhythmia 9. Hospitalization for heart failure within the past year 10. Known active tuberculosis 11. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years 12. History of life-threatening pulmonary obstruction 13.History of cystic fibrosis 14. Clinically evident bronchiectasis 15.History of significant alcohol or drug abuse 16. History of thoracotomy with pulmonary resection 17. oral or patch ß-adrenergics 18. Oral corticosteroid medication within 6 weeks prior to Visit 1 19. Regular use daytime oxygen therapy for more than one hour per day 20. Pulmonary rehabilitation program in the six weeks prior to the screening visit 21. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit 22. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA 23. Pregnant or nursing women |
1. Pacientes con una enfermedad significativa distinta de EPOC 2. Pacientes que han sufrido una exacerbación de la EPOC que ha requerido tratamiento con antibióticos, corticosteroides sistémicos (orales o intravenosos) u hospitalización en los últimos 3 meses. 3. Pacientes que que tienen una hematología, bioquímica o análisis de orina basales anormales 4. Pacientes con antecedentes de asma. 5. Diagnóstico de la tirotoxicosis 6. Diagnóstico de taquicardia paroxística 7. Antecedentes de infarto de miocardio 8. Arritmia cardiaca inestable o potencialmente mortal. 9. Hospitalización por insuficiencia cardíaca en el último año. 10. Tuberculosis activa conocida. 11. Una neoplasia maligna por la que el paciente se haya sometido a resección, radioterapia o quimioterapia en los últimos cinco años 12. Antecedentes de obstrucción pulmonar potencialmente mortal. 13. Antecedentes de fibrosis quística. 14. Bronquiectasia clínicamente sintomática. 15. Antecedentes de consumo significativo de alcohol o drogas. 16. Pacientes que hayan sido sometidos a toracotomía con resección 17. Pacientes en tratamiento con adrenérgicos ? orales o en parche. 18. Pacientes en tratamiento con corticosteroides orales en las 6 semanas anteriores a la Visita 1. 19. Pacientes que reciben oxigenoterapia diurna de forma habitual durante más de una hora al día 20. Pacientes que hayan completado un programa de rehabilitación pulmonar en las seis semanas previas a la visita de selección 21. Pacientes que hayan recibido un fármaco en investigación un mes, seis semividas o, antes de la visita de selección (visita 1). 22. Pacientes con hipersensibilidad conocida a fármacos adrenérgicos ?, BAC, EDTA, 23. Mujeres embarazadas o en periodo de lactancia. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1: FEV1 AUC0-12h - change from baseline after 6 weeks of treatment |
AUC0-12h de la respuesta del FEV1 [L] tras 6 semanas de tratamiento. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1: Baseline and 6 weeks |
Tras 6 semanas de tratamiento |
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E.5.2 | Secondary end point(s) |
1: FEV1 AUC0-24h - change from baseline 6-weeks of treatment.
2: Trough FEV1- change from baseline 6-weeks of treatment.
3: FEV1 AUC 12-24 h - change from baseline 6-weeks of treatment.
4: Peak 0-3h FEV1- change from baseline 6-weeks of treatment. |
1: AUC0-24h de la respuesta del FEV1 [L] tras 6 semanas de tratamiento 2: Respuesta Trough (valle) del FEV1 [L] tras 6 semanas de tratamiento 3: AUC12-24h de la respuesta del FEV1 [L] tras 6 semanas de tratamiento 4: Respuesta máxima 0-3h de la FVC [L] tras 6 semanas de tratamiento |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: Baseline and 6 weeks
2: Baseline and 6 weeks
3: Baseline and 6 weeks
4: Baseline and 6 weeks |
1: Tras 6 semanas de tratamiento 2: Tras 6 semanas de tratamiento 3: Tras 6 semanas de tratamiento 4: Tras 6 semanas de tratamiento |
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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) | 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 | No |
E.8.1.6 | Cross over | Yes |
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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
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 | No |
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
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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 | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 21 |