Treatment in non-smoking adult patients with mild persistent atopic bronchial asthma MedDRA version: 14.1 Level: LLT Classification code 10003555 Term: Asthma bronchial System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: budesonide
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical Form: Inhalation powder
Sponsors
Fundació per la Recerca i la Docència Sant Joan de Déu
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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).;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. ;Timepoint(s) of evaluation of this end point: ACT symptom scale at each control visit (V1-V5) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a ) Clinical symptoms b) Pulmonary function;Timepoint(s) of evaluation of this end point: . | — |
Countries
Spain
Contacts
Public ContactDña. Rosa María Morales Palau
Fundació per la Recerca i la Docència Sant Joan de Déu
Outcome results
None listed