E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cough in the context of acute bronchitis |
Tos en el contexto de una bronquitis aguda |
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E.1.1.1 | Medical condition in easily understood language |
Acute bronchitis with cough |
Bronquitis aguda con tos |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006451 |
E.1.2 | Term | Bronchitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 clinical effectiveness of adding 3 symptomatic treatments (dextromethorphan, ipratropium bromide or honey) to normal practice in the reduction of days with moderate-severe cough compared with usual practice |
Evaluar la efectividad clínica de añadir a la práctica habitual 3 tratamientos sintomáticos (dextrometorfano, bromuro de ipratropio o miel) en la reducción de días con tos moderada-grave comparado con la práctica habitual |
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E.2.2 | Secondary objectives of the trial |
To evaluate the clinical effectiveness of adding 3 symptomatic treatments to the usual practice compared to the usual clinical practice in: - The reduction of days until resolution of acute bronchitis - Reduction of days with moderate-severe diurnal cough - The reduction of days with moderate-severe nighttime cough - Duration in days of cough - The duration in days of severe symptoms - The duration in days of severe or moderate symptoms - According to the basal degree of bronchial hyperreactivity quantified by peak-flow - The use of antibiotics and different symptomatic treatments - The number of days of absenteeism - The number of times the patient returns to consult - The number of complications - Patient satisfaction
Evaluate the adverse reactions in each of the test strategies |
Evaluar la efectividad clínica de añadir a la práctica habitual 3 tratamientos sintomáticos comparado con la práctica clínica habitual en: - La reducción de días hasta resolución de la bronquitis aguda - La reducción de días con tos moderada-grave diurna - La reducción de días con tos moderada-grave nocturna - La duración en días de tos - La duración en días de síntomas graves - La duración en días de síntomas graves o moderados - Según el grado basal de hiperreactividad bronquial cuantificado por peak-flow - El uso de antibióticos y distintos tratamientos sintomáticos - El número de días de absentismo laboral - El número de veces que el paciente vuelve a acudir a consulta - El número de complicaciones - La satisfacción de los pacientes
Evaluar las reacciones adversas en cada una de las estrategias de ensayo |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients aged 18 years or older, who come to the primary care physician with cough of up to 3 weeks of evolution in the context of acute bronchitis and who agree to participate in the clinical trial. - Patients who score ≥4 in daytime and / or nighttime on the Likert scale of 6 points. |
- Pacientes de 18 años o más, que acudan al médico de atención primaria con tos de máximo 3 semanas de evolución en el contexto de una bronquitis aguda y que acepten participar en el ensayo clínico. - Pacientes que puntúen ≥4 en tos diurna y/o nocturna en la escala Likert de 6 puntos. |
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E.4 | Principal exclusion criteria |
- Suspected pneumonia. - Patient with criteria for hospital referral - Pregnancy or lactation. - Basic respiratory disease: chronic obstructive pulmonary disease, asthma, tuberculosis or bronchiectasis. - Associated significant comorbility: moderate-severe heart failure, dementia, acute myocardial infarction / recent stroke (<3 months), severe hepatic insufficiency, severe renal insufficiency. - Immunosuppression. - Active neoplasia - Terminal disease - History of intolerance or allergy to any of the study treatments. - Patients in whom, in the opinion of the researcher, treatment with dextromethorphan, ipratropium bromide or honey is contraindicated. - Institutionalized patients. - Difficulty making scheduled follow-up visits. |
- Sospecha de neumonía. - Paciente con criterios de derivación hospitalaria - Embarazo o lactancia. - Enfermedad respiratoria de base: enfermedad pulmonar obstructiva crónica, asma, tuberculosis o bronquiectasias. - Comorbilidad significativa asociada: insuficiencia cardíaca moderada-grave, demencia, infarto agudo de miocardio / accidente vascular cerebral reciente (<3 meses), insuficiencia hepática severa, insuficiencia renal severa. - Inmunosupresión. - Neoplasia activa - Enfermedad terminal - Historia de intolerancia o alergia a alguno de los tratamientos de estudio. - Pacientes en los que, a juicio del investigador, esté contraindicado el tratamiento con dextrometorfano, bromuro de ipratropio o miel. - Pacientes institucionalizados. - Dificultad para realizar las visitas programadas de seguimiento. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Day reduction in the duration of moderate-severe cough |
Reducción de días en la duración de la tos moderada-grave |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Daily evaluation by the patient's diary, which is collected in the face-to-face visit on day 15 and, if necessary, on the 29th day. |
Evaluación diaria mediante diario del paciente, que se recoge en visita presencial día 15 y de ser necesario, día 29. |
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E.5.2 | Secondary end point(s) |
Duration in days of: - symptomatology - moderate-severe diurnal cough - moderate-severe nighttime cough - cough - severe symptoms - severe or moderate symptoms Bronchial hyperreactivity degree difference Use of antibiotics and other symptomatic treatments Number of days of absenteeism Number of times the patient returns to consult Number of complications Degree of satisfaction Number of adverse reactions |
Duración en días de: - sintomatología - tos moderada-grave diurna - tos moderada-grave nocturna - tos - síntomas graves - síntomas graves o moderados Diferencia grado hiperreactividad bronquial Uso de antibióticos y otros tratamientos sintomáticos Número de días de absentismo laboral Número de veces que el paciente vuelve a acudir a consulta Número de complicaciones Grado de satisfacción Número de reacciones adversas |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The variables evaluated by reduction in days will be collected daily by the patient in the symptom diary, of 14 days and, if necessary, 28 days. The researcher will collect and review the diary in the face-to-face visits of the 15th and 29th. Difference degree bronchial hyperreactivity: day 15 Use of antibiotics and other symptomatic treatments: day 15 and day 29 Number of days of work absenteeism: day 15 Number of times the patient returns to consult: day 29 and call day 42 Number of complications: day 29 and call day 42 Degree of satisfaction: day 15 or day 29 Number of adverse reactions: day 15 and day 29 |
Las variables evaluadas mediante reducción en días las recogerá diariamente el paciente en el diario de sintomatología, de 14 días y si es necesario de 28 días. El investigador recogerá y revisará el diario en las visitas presenciales del día 15 y día 29. Diferencia grado hiperreactividad bronquial: día 15 Uso de antibióticos y otros tratamientos sintomáticos: día 15 y día 29 Número de días de absentismo laboral: día 15 Número de veces que el paciente vuelve a acudir a consulta: día 29 y llamada día 42 Número de complicaciones: día 29 y llamada día 42 Grado de satisfacción: día 15 o día 29 Número de reacciones adversas: día 15 y día 29 |
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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 | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.8.1.3 | Single blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Miel (3r brazo) y práctica clínica habitual (comparador) |
Honey (3rd arm) and usual care (comparator) |
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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 | 12 |
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
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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 | 1 |
E.8.9.1 | In the Member State concerned days | 15 |