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

Phase 2

Active, not recruiting

• Conditions: Asthma
• Interventions: Drug: Fluticason either Beclometasone or Budesonide; Drug: Salbutamol

• Registration Number: NCT06482294
• Lead Sponsor: Università degli Studi di Ferrara

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.

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-18
• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-25
• Last Update Submitted: 2024-06-29
• Study First Posted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-05-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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).

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Anti-inflammatory rescue medication	Fluticason either Beclometasone or Budesonide	(Salbutamol 200 mcg + either Fluticason 250 mcg DPI or Beclometasone 400 mcg DPI or Budesonide 400 mcg pMDI ) x2
Non ant-inflammatory rescue medication	Salbutamol	Salbutamol 200 mcg pMDI x2

Primary Outcome Measures

Name	Time	Method
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.	Inflammation will be assessed as FeNO levels after an anti inflammatory rescue medication compared to a non anti inflammatory rescue medication therapy repeatedly measured up to 48 hours at defined intervals

Secondary Outcome Measures

Name	Time	Method
Change in FEV1	Patients are asked to perform repeated measurements of FEV1 from the onset of symptoms to 48 hours after the administration of the rescue medication.	The change in FEV after administration of an anti-inflammatory rescue medication and a non-anti-inflammatory rescue medication.
change in Visual Analogue Scale (VAS) scale.	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.	The change in VAS scale, used to measure the intensity of symptoms (0 lowest intensity, 10 highest intensity) after administration of an anti-inflammatory rescue medication and a non-anti-inflammatory rescue medication.

Trial Locations

Locations (1)

Research Centre on Asthma and COPD, University of Ferrara; 🇮🇹 Ferrara, Italy