Evaluation of the consequences on the inflammatory profile with the use of inhaled steroids in association with therapy with inhaled bronchodilators in the reliever therapy of asthma.

Phase 1

• Conditions: 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: 20.0Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: PTClassification code 10064823Term: Asthmatic crisisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2022-002677-29-IT
• Lead Sponsor: AZIENDA OSPEDALIERO UNIVERSITARIA DI FERRARA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-14
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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

- 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);

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified