E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment in non-smoking adult patients with mild persistent atopic bronchial asthma |
Tratamiento en pacientes no fumadores adultos con asma bronquial leve persistente atópico |
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E.1.1.1 | Medical condition in easily understood language |
Treatment in non-smoking adult patients with mild persistent atopic bronchial asthma |
Tratamiento en pacientes no fumadores adultos con asma bronquial leve persistente atópico |
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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 | 10003555 |
E.1.2 | Term | Asthma bronchial |
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 determine if monitoring nitric oxide (FeNO) values in exhaled air, a biomarker of bronchial inflammation, can be used as a tool which correlates with adequate symptomatic control and allows the optimisation of treatment in non-smoking adult patients with mild persistent atopic bronchial asthma, thus allowing withdrawal of treatment with inhaled glucocorticoids in patients with stable mild atopic asthma |
Determinar si la monitorización de los valores de óxido nítrico en aire expirado (FeNO), biomarcador de inflamación bronquial, puede utilizarse como herramienta que se correlacione con el correcto control sintomático y permita la optimización del tratamiento en pacientes no fumadores adultos con asma bronquial leve persistente atópico, y permitir así la retirada del tratamiento glucocorticoideo inhalado en pacientes con asma atópico leve estable. |
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E.2.2 | Secondary objectives of the trial |
a) To evaluate the relationship between FeNO values after withdrawal of maintenance treatment with glucocorticoids and the individual clinical symptoms of the patient, exacerbations and quality of life.
b) To evaluate the relationship between FeNO values and complete pulmonary function tests measuring static volumes, including air trapping (as a marker of small airways). |
a) Valorar la relación de los valores de FeNO, tras la retirada del tratamiento de mantenimiento con glucocorticoides, con la sintomatología clínica individual del paciente, las exacerbaciones y la calidad de vida.
b) Valorar la relación entre el valor de FeNO y las pruebas de función pulmonar completas con volúmenes estáticos incluyendo el atrapamiento aéreo (como marcador de la pequeña vía aérea). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients who have previously given their informed consent to participate in the study will be included. a) Aged between 18 and 65 years. b) Initial diagnosis of mild persistent bronchial asthma according to the definition of the latest GEMA guidelines, well controlled with no exacerbations in the previous 3 months, ACT>20, normal spirometry and negative bronchodilator test. Patients already known and managed in the Pneumology Department of Parc Sanitari Sant Joan de Déu will be included. c) Atopy, defined as: elevated total IgE and/or allergy tests (skin prick or RAST testing) positive for respiratory pneumoallergens and/or peripheral eosinophilia. |
Se incluirá a pacientes que hayan dado previamente su consentimiento informado sobre la participación en el estudio.
a) Edad entre 18 y 65 años.
b) Diagnóstico inicial de asma bronquial leve persistente según la definición incluida en la última guía GEMA bien controlado sin exacerbaciones en los últimos 3 meses, ACT>20 y espirometría normal con prueba broncodilatadora negativa. Se incluirán pacientes ya conocidos y controlados en el Servicio de Neumología del Parc Sanitari Sant Joan de Déu.
c) Atopia definida por: IgE total elevada, y/o Pruebas de Alergia (Prick Test o Rast) positivas a neumoalérgenos respiratorios y/o eosinofilia periférica. |
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E.4 | Principal exclusion criteria |
a) Patients who do not fulfil the criteria defined in the GEMA guidelines for uncontrolled mild persistent bronchial asthma. b) Patients with an obstructive pattern on spirometry explained by another disease: COLD, sequelae of tuberculosis, bronchiolitis, etc. c) Patients who are clinically unstable at the time of inclusion or who have worsened in the 3 months prior to study inclusion. d) Patients who cannot correctly take treatment via the inhaled route. e) Patients with muscular disorders (myasthenia gravis, Parkinson’s). f) Patients who are smokers or ex-smokers. g) Patients requiring essential treatment which may produce bronchoconstriction of the airways (e.g. beta-blockers). h) Women who are pregnant or nursing. j) Patients included in any other research protocol. |
a) Pacientes en los que no se cumplan los criterios definidos por la guía GEMA para asma bronquial leve persistente no controlado.
b) Pacientes con patrón obstructivo en la espirometría justificado por otra patología: EPOC, secuelas tuberculosis, bronquiolitis, etc.
c) Pacientes con inestabilidad clínica en el momento de inclusión o con agudización en los últimos 3 meses previos a la inclusión en el estudio.
d) Pacientes que no sean capaces de realizar de forma correcta el tratamiento por vía inhalatoria.
e) Pacientes con trastornos musculares (miastenia gravis, parkinson).
f) Pacientes fumadores o exfumadores.
g) Pacientes con patologías que requieran de un tratamiento indispensable que pueda provocar broncoconstricción de la vía aérea (ej. Betabloqueantes).
h) Mujeres embarazadas o en período de lactancia.
i) Pacientes con antecedentes de alergia a glucocorticoides.
j) Pacientes incluidos en cualquier otro protocolo de investigación. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Symptomatic control will be measured according to the ACT symptom scale at each control visit (V1-V5), to determine if the measurement of FeNO is a useful tool in deciding on the withdrawal of inhaled glucocorticoid treatment in patients with stable mild persistent atopic bronchial asthma. A variation of 2 points on this scale is considered clinically significant.
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Se valorará el control sintomático medido por la escala ACT de síntomas en cada visita de control (V1-V5), para determinar si la medición del FeNO es una herramienta útil en la decisión de retirada de tratamiento glucocorticoideo inhalado en pacientes con asma bronquial leve persistente atópico estable.
Se considera clínicamente significativo la variación de 2 puntos en dicha escala. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
ACT symptom scale at each control visit (V1-V5) |
La escala ACT de síntomas en cada visita de control (V1-V5) |
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E.5.2 | Secondary end point(s) |
a ) Clinical symptoms
b) Pulmonary function |
a) Sintomatología clínica
b) Función pulmonar |
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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 | 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 | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
| 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
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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 | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |