Clinical trial NCT06482294: CIVETTA: Correlating Inflammatory Values of FEno, SympToms, SpuTum and Lung Function in Asthma
Official title: CIVETTA: Correlating Inflammatory Values of FEno, SympToms, SpuTum and Lung Function in Asthma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: crossover design according to the AB/BA scheme
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: The study is structured into two distinct and separate phases, an observational and an interventional.

- Phase 1: Observational Phase The observational component of the study aims to describe the variations in airway inflammation at the onset of asthma symptoms when patients (n=50) are under the appropriate anti-asthma therapy (Standard Of Care, SOC), which includes a rapid-onset bronchodilator (RABD) as needed. The RABD used may be either salbutamol or formoterol, depending on the therapeutic strategy employed by the patient and the GINA Track followed.

Before and after taking the SOC rescue medication, the patient will measure markers of airway inflammation and clinical impact (FeNO, FEV1, PEF, VAS scale) using the "PEFESP kit" provided to each enrolled patient. They will record these values in the "patient diary" for the subsequent 48 hours.

- Phase 2: Interventional Phase In a crossover design according to the AB/BA scheme, it will be assessed whether there are differences in the airway inflammation profile in patients (n=30) using a reliever medication containing ICS compared to a reliever medication containing only a bronchodilator.

The interventional phase consists of two open-label monitoring phases, each lasting a maximum of 3 weeks, separated by a washout period of 3 to 7 days and for a maximum of 3 symptom episodes. As in the observational part, patients will be asked to record the markers of airway inflammation and the clinical impact of symptoms at the onset of the change from stable condition and in the 48 hours following the administration of the reliever medication.

Patient with mild asthma will be the first group of severity enrolled in the study.

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)

Primary outcomes:
measure: 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
timeFrame: 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.
Secondary outcomes:
measure: Change in FEV1
timeFrame: Patients are asked to perform repeated measurements of FEV1 from the onset of symptoms to 48 hours after the administration of the rescue medication.
measure: change in Visual Analogue Scale (VAS) scale.
timeFrame: Patients are asked to perform repeated measurements of VAS scale from the onset of symptoms to 48 hours after the administration of the rescue medication.
Other outcomes:
measure: Change in sputum eosinophils count
timeFrame: Patients are asked to perform repeated sputum collections from the onset of symptoms until 48 hours after the administration of the rescue medication.
Locations:
city: Ferrara
country: Italy
facility: Research Centre on Asthma and COPD, University of Ferrara
Study officials:
affiliation: Università degli Studi di Ferrara
name: Alberto Papi, MD
role: PRINCIPAL_INVESTIGATOR
References: