Asthma, a chronic inflammatory disease of the airways, is characterized by a variability of symptoms that can evolve in an acute and sometimes severe form. Treatment of asthma involves daily treatment and reliever therapy. The characteristics of the inflammation underlying the disease are still under study as they are very heterogeneous. In 50% of cases, the inflammation is of type T-helper 2 high, characterised by atopy, high levels of eosinophils in the blood and sputum. MedDRA version: 20.0
Conditions
Interventions
Product Name: Budesonide
Product Code: [-]
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: BUDESONIDE
Current Sponsor code: NA
Concentration unit: µg microgram(s)
Concentration type: up to
Sponsors
AZIENDA OSPEDALIERO UNIVERSITARIA DI FERRARA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age> 18 years at the time of signing the informed consent; Patients already followed for bronchial asthma according to ERS / ATS criteria - GINA update 2022; Mild and moderate asthma (GINA steps 1-3), with the exclusion of patients with severe asthma (GINA steps 4-5). 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Inability to sign informed consent; - Diagnosis of other clinically significant respiratory diseases; - Diagnosis of Chronic Obstructive Pulmonary Disease (COPD); - History of smoking > 10 packs/year or suspension for less than 3 months; - Oral steroid therapy cycle in the 2 months before enrollment; - Number of asthma exacerbations per year = 2; - Pregnancy; - Evidence of clinically significant pathologies in other systems outside the respiratory system (i.e. cardiovascular, hepatic, renal, nervous, endocrinological, oncological, dermatological systems);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to describe, in patients with mild/moderate asthma, the changes in the inflammatory profile in correspondence with the onset of asthma symptoms that lead to the use of fast-acting bronchodilator reliever therapy (RABD) The inflammatory and functional status of the patient’s airways will be assessed by measuring FeNO levels, eosinophils sputum counts and peak expiratory flow both in conditions of clinical stability and in correspondence with the onset of symptoms that lead the subject to use the rescue medication.;Secondary Objective: Considering the susceptibility of asthmatic inflammation to inhaled steroid therapy, when patients take inhaled steroid together with bronchodilator as per the cross-over protocol, will evaluate the influence that the inhaled steroid has on the inflammatory profile after its use together with RABD in as-needed therapy.;Primary end point(s): To evaluate the characteristics of airway inflammation and its variations in correspondence with the onset of asthma symptoms that lead to the use of reliever therapy (RABD): - FeNO levels in exhaled air as an indirect index of T2 inflammation typical of bronchial asthma; - the levels of eosinophilia in the sputum in absolute value and as a percentage as a direct index of T2 inflammation typical of bronchial asthma; - both in relation to the respiratory function studied by FEV1 and PEF values.;Timepoint(s) of evaluation of this end point: From V1 (screening and baseline) to V6 (follow-up visit) for up to 6 weeks of home monitoring. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The influence of the inhaled steroid in reliever therapy (in addition to RABD). In patients who will take the inhaled steroid associated with RABD as reliever therapy, the inflammatory profile will be monitored for up to 48 hours (basal FENO, FENO after inhalation therapy at regular intervals, sputum collection before and after therapy with assessment of levels of eosinophilia in absolute and percentage values). Will be evaluated: - FeNO levels in the exhaled air before ICS-containing inhalation therapy and up to 48 hours after at regular intervals; - the number and percentage of eosinophils in the sputum before inhalation therapy in the two arms and after at least 3 hours from this; - the correlation between changes in PEF and/or FEV1 in the two groups in relation to changes in the inflammatory profile (FeNO and/or eosinophils in the sputum) before and after inhalation therapy; - the correlation between the changes in the VAS scale in the two groups in relation to changes in the inflammatory profile (FeNO and/or eosinophils in the sputum) before and after inhalation therapy; - the time interval between taking reliever therapy and the subjective improvement of symptoms in both groups after the administration of questionnaires (VAS scale); - any correlation between changes in PEF and/or FEV1 in relation to symptomatic changes (VAS scale); - any correlation between changes in FeNO in relation to symptomatic variations (VAS scale); - any correlation between changes in eosinophils in the sputum in relation to symptomatic changes (VAS scale); - evaluate the number of episodes of asthma symptoms in the two groups during the entire duration of the monitoring; - the change in respiratory function values ¿¿(spirometry at the randomization visit and spirometry at the end of monitoring visit) and airway resistance via IOS (IOS at the randomization visit and at the end of monitoring visit) in the two groups. - the correlation between eosinophilia and Fe | — |
Countries
Italy
Contacts
Public ContactCEMICEF Ambulatorio 1E0
Azienda Ospedaliero Universitaria di Ferrara
Outcome results
None listed