E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
bronchiectasis |
BRONQUIECTASIAS |
|
E.1.1.1 | Medical condition in easily understood language |
chronic airway inflammatory disease involving dilation of the bronchi |
enfermedad crónica inflamatoria de las vías aéreas con dilatación de los bronquios |
|
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 | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006445 |
E.1.2 | Term | Bronchiectasis |
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 evaluate the effect of the combination of once-daily 7% hypertonic saline and twice-daily ELTGOL technique in mucus clearance in patients with bronchiectasis compared both to once-daily isotonic saline and twice-daily ELTGOL technique and to twice-daily ELTGOL technique on its own |
Evaluar el efecto de la combinación de la inhalacion de suero salino hipertónico al 7% una vez al día y la técnica ELTGOL dos veces al día en el aclaramiento de moco en pacientes con bronquiectasia en comparación con la inhalacion de suero salino isotónico y la técnica ELTGOL dos veces al día y con la técnica ELTGOL dos veces al día |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the effects of the three treatment regimes on the impact of cough, exacerbations, mucus properties, quality of life, sputum cultures and pulmonary function in these patients. - To assess possible side effects - To assess adherence to the different regimes - To assess whether the effects are sustained one month after the treatment is ended |
- Evaluar los efectos de los tres regímenes de tratamiento sobre el impacto de la tos, las exacerbaciones, las propiedades del moco, la calidad de vida, los cultivos de esputo y la función pulmonar en estos pacientes. - Evaluar los posibles efectos secundarios - Evaluar la adherencia a los diferentes regímenes. - Evaluar si los efectos se mantienen un mes después de finalizado el tratamiento |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Men and woman,≥ 18 years old with bronchiectasis confirmed by high resolution computed tomography, with no exacerbations in the previous month, chronic purulent sputum (≥10ml daily expectoration), at least one exacerbation in the previous year, FEV1 ≥30% after bronchodilation and sign the informed consent |
Hombres y mujeres mayores de 18 años con bronquiectasia confirmada por tomografía computarizada de alta resolución, sin exacerbaciones en el mes anterior, con expectoración diaria de esputo purulento (≥10 ml/dia), al menos una exacerbación en el año anterior, FEV1 ≥30% después de la broncodilatación y firmar el consentimiento informado |
|
E.4 | Principal exclusion criteria |
≥85 years old,asthma, allergic bronchopulmonary aspergillosis or CF; current smokers or a smoking history of ≥20 p-y; following mucoactive treatment in the month previous; contraindications to perform ELTGOL, spirometry or to attend visits; practising pulmonary rehabilitation in the previous 6 months, change of treatment the previous month; uncontrolled hypertension |
pacientes mayores de 85 años,asma, aspergilosis broncopulmonar alérgica o FQ; fumadores actuales o antecedentes de tabaquismo ≥20 p-y; tratamiento mucoactivo en el mes anterior; contraindicaciones para realizar ELTGOL, espirometría o asistir a visitas; practicando rehabilitación pulmonar en los 6 meses anteriores, y cambio de tratamiento el mes anterior; hipertensión arterial no controlada |
|
E.5 End points |
E.5.1 | Primary end point(s) |
the change in the sputum weight in grams during intervention from baseline to V7 |
El cambio en el peso del esputo en gramos durante la intervención desde el inicio hasta V7 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Change from baseline in the 24h sputum volume in millilitres and sputum weight during the intervention and 24 hours later over the 12-month treatment period. - Change in cough assessed with the Leicester Cough Questionnaire from V2 over the 12-month treatment period. - Number of exacerbations and the time to the first exacerbation over the 12-month treatment period. - Change in sputum purulence assessed by the sputum colour chart, mucus properties, and microbiology from V2 to V7. -Change in quality of life (assessed with Bronchiectasis health questionnaire and Saint George Respiratory questionnaire) from V2 over the 12-month treatment period -Change from V2 in post-bronchodilator FEV1 over the 12-month treatment period in ml - Treatment adherence assessed through vial counting, Morisky-Green test, the diary card. - Adverse events assessed by symptoms reported, vital sign measurement (including blood pressure and arterial oxygen saturation), physical examination, Borg scale at the end of interventions at V2, V3, V5, V7, and pulmonary function tests at V2. - Change from V7 to V8 in the 24h sputum volume, colour and weight, quality of life and FEV1 |
- Cambio desde el estado basal en el volumen de esputo de 24 h en mililitros y el peso del esputo durante la intervención y 24 horas después durante el período de tratamiento de 12 meses. - Cambio en la tos evaluada con el Leicester Cough Questionnaire de V2 durante el período de tratamiento de 12 meses. - Número de exacerbaciones y el tiempo hasta la primera exacerbación durante el período de tratamiento de 12 meses. - Cambio en la purulencia del esputo evaluado por la tabla de colores del esputo, propiedades de moco y microbiología de V2 a V7. -Cambio en la calidad de vida (evaluado con el cuestionario de salud de bronquiectasia y el cuestionario respiratorio de Saint George) a partir de V2 hasta visita 7 -Cambio de V2 en FEV1 post-broncodilatador durante el período de tratamiento de 12 meses en ml - Adherencia al tratamiento evaluada a través del conteo de viales, prueba Morisky-Green, la tarjeta del diario. - Eventos adversos evaluados por los síntomas informados, medición de signos vitales (incluyendo presión arterial y saturación de oxígeno arterial), examen físico, escala de Borg al final de las intervenciones en V2, V3, V5, V7 y pruebas de función pulmonar en V2. - Cambio de V7 a V8 en el volumen de esputo de 24 h, color y peso, calidad de vida y FEV1 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
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 | Yes |
E.8.1.4 | Double blind | No |
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 | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | 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
|
LVLS |
ULTIMA VIISTA DEL ULTIMO PACIENTE |
|
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 |