E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
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 the clinical efficacy and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different total daily doses of Fluticasone Propionate Inhalation Powder taken using a twice daily regimen from nDPI for 16 weeks in subjects with severe persistent asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative for Asthma (GINA) guidelines (GINA 2011). |
Evaluar la eficacia clínica y la relación dosis-respuesta, con corticosteroides orales de modulación, de 3 diferentes dosis diarias totales de Polvo inhalado de propionato de fluticasona tomado con un régimen de dos veces al día durante 16 semanas en sujetos con asma grave persistente que requiere terapia con corticosteroides orales de modulación |
|
E.2.2 | Secondary objectives of the trial |
-To evaluate the safety and tolerability of 3 different total daily doses of Fluticasone Propionate Inhalation Powder in subjects with severe persistent asthma requiring OCS therapy; -To evaluate the subjects? operation and handling of the new dry powder inhaler (nDPI). |
Evaluar la eficacia clínica y la relación dosis-respuesta, con corticosteroides orales de modulación, de 3 diferentes dosis diarias totales de Polvo inhalado de propionato de fluticasona en sujetos con asma grave persistente que requiere terapia con corticosteroides orales de modulación -Para evaluar el funcionamiento y manejo por los sujetos del inhalador de polvo seco nuevo |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Adolescents aged 12 to 17 years (inclusive) and adults aged 18 to 65 years (inclusive) -Documented clinical history of severe asthma requiring oral prednisone/prednisolone therapy -Adult asthmatic subjects having FEV1 ?40% of predicted value based on National Health and Nutrition Examination Survey (NHANES) III reference equations for United States (US) centres, and European Community for Coal and Steel (ECCS) reference equations for all other centres |
Adolescentes de entre 12 y 17 años (inclusive) y adultos de entre 18 y 65 años (inclusive). Antecedentes clínicos documentados de asma grave que requiere terapia con prednisona/prednisolona Sujetos adultos asmáticos con VEF1 ? 40 % del valor pronosticado según las ecuaciones de referencia de la NHANES III para centros de los EE. UU. (Hankinson y otros 1999) y las ecuaciones de referencia de la ECCS (Quanjer y otros 1993) para todos los demás centros. |
|
E.4 | Principal exclusion criteria |
- Subjects who have or who have had an upper or lower respiratory tract infection within 28 days of the Screening Visit - Subjects with asthma that required admission to an intensive care unit and/or ventilation within the previous 12 months - History of lung cancer |
- Los sujetos que tienen o que han tenido una infección del tracto respiratorio superior o inferior dentro de los 28 días siguientes a la visita de selección - Los sujetos con asma que requirieron ingreso en una unidad de cuidados intensivos y / o ventilación dentro de los 12 meses anteriores - Antecedentes de cáncer de pulmón |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Mean ?Prednisone/prednisolone Dose for Analysis? (PDA). |
PDA - Prednisona/perednisolona dosis para análisis |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Start of treatment to last study visit |
Inicio de tratamiento para última visita del estudio |
|
E.5.2 | Secondary end point(s) |
Efficacy: Variety of calculations measuring change in dose of prednisone/prednisolone Safety: Vital signs; Physical examination; Oropharyngeal examination;12-lead ECG; 24HUC; Inhaler: The inhaler variables will be assessments of Compliance; Operation; Acceptability. |
Eficacia: La variedad de cálculos que miden el cambio en la dosis de prednisona / prednisolona Seguridad: Los signos vitales, examen físico, examen orofaríngeo; ECG de 12 derivaciones; 24HUC; Inhalador: Las variables inhalador se disponga de evaluaciones de la conformidad; Operación; Aceptabilidad. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Start of treatment to last study visit |
Inicio de tratamiento para última visita del estudio |
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Operation and handling of inhaler |
Funcionamiento y manejo de inhalador |
|
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 | Yes |
E.8.1.7.1 | Other trial design description |
de intérvalo de dosis |
dose-ranging |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
3 dosis del mismo producto |
3 doses of the same product |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 55 |
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 |
Canada |
Ukraine |
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
|
|
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 | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |