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Clinical trial

CIVETTA: Correlating Inflammatory Values of FEno, SympToms, SpuTum and Lung Function in Asthma

ID
Name
4739 - 2022-002677-29
Description
Single-center, interventional, open-label, randomized phase II study aimed at describing the changes in airway inflammation at the onset of asthma symptoms that lead to the use of rapid acting bronchodilator (RABD) as a rescue medication in a mild to moderate asthma population. The study will assess whether there are differences in the airway inflammation profile in patients using a reliever medication containing ICS (anti-inflammatory rescue strategy) compared to a reliever medication containing only a bronchodilator for symptom relief (Non anti-inflammatory rescue strategy).
Trial arms
Trial start
2024-06-18
Estimated PCD
2025-05-01
Trial end
2025-07-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Salbutamol
One arm is a combination of salbutamol and fluticason as a rescue medication (anti-inflammatory rescue medication). The second arm is salbutamol only as a rescue medication (non-anti-inflammatory rescue medication).
Arms:
Non ant-inflammatory rescue medication
Other names:
Salbutamol sulphate 200 mcg, pMDI
Fluticason either Beclometasone or Budesonide
One arm is a combination of salbutamol and an ICS as a rescue medication (anti-inflammatory rescue medication). The second arm is salbutamol only as a rescue medication (non-anti-inflammatory rescue medication).
Arms:
Anti-inflammatory rescue medication
Other names:
Fluticason Propionate 250 mcg DPI or Beclometasone dipropionate 400 mcg DPI or Budesonide 400 mcg pMDI or Budesonide 200 mcg DPI
Size
80
Primary endpoint
To evaluate airway inflammation characteristics and changes at the onset of asthma symptoms requiring as-needed therapy (RABD) and the impact of inhaled steroid therapy in addition to RABD on airway inflammation
Patients are asked to perform repeated measurements of airway inflammation from the onset of symptoms to 48 hours after the administration of the rescue medication.
Eligibility criteria
Inclusion Criteria: * Patients already followed for asthma according to ERS/ATS criteria * Mild and moderate asthma (GINA steps 1-3), with the exclusion of patients with severe asthma (GINA steps 4-5). Exclusion Criteria: Severe asthma (Gina steps 4 and 5) * Inability to give informed consent * Diagnosis of other clinically significant respiratory diseases * Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) * History of smoking: \> 10 pack/year or stop for less than 3 months * Oral steroid therapy in the 2 months prior to enrollment * Number of asthma exacerbations per year ≥ 2 * Pregnancy * Evidence of clinically significant pathologies other than in respiratory system (i.e., cardiovascular, hepatic, renal, nervous, endocrinological, oncological, dermatological systems)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'crossover design according to the AB/BA scheme', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-07-01

1 organization

2 products

1 indication

Organization
Università degli Studi di Ferrara
Product
Salbutamol
Indication
Asthma
Product
Fluticason