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

NCT06482294 | Active Not Recruiting Phase 2

• 1 other identifier: 4739 - 2022-002677-29
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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 (2)

• 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.

• 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.

Other Outcomes (1)

• Change in sputum eosinophils count

  Patients are asked to perform repeated sputum collections from the onset of symptoms until 48 hours after the administration of the rescue medication.

Study Arms (2)

Non ant-inflammatory rescue medication

EXPERIMENTAL

Salbutamol 200 mcg pMDI x2

Drug: Salbutamol

Anti-inflammatory rescue medication

EXPERIMENTAL

(Salbutamol 200 mcg + either Fluticason 250 mcg DPI or Beclometasone 400 mcg DPI or Budesonide 400 mcg pMDI ) x2

Drug: Fluticason either Beclometasone or Budesonide

Interventions

Salbutamol DRUG

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).

Also known as: Salbutamol sulphate 200 mcg, pMDI

Non ant-inflammatory rescue medication

Fluticason either Beclometasone or Budesonide DRUG

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).

Also known as: Fluticason Propionate 250 mcg DPI or Beclometasone dipropionate 400 mcg DPI or Budesonide 400 mcg pMDI or Budesonide 200 mcg DPI

Anti-inflammatory rescue medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients already followed for asthma according to ERS/ATS criteria

You may not qualify if:

• 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)

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Research Centre on Asthma and COPD, University of Ferrara

Ferrara, 44121, Italy

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol; Budesonide; Beclomethasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienetriols; Pregnadienes; Steroids, Chlorinated

Study Officials

• Alberto Papi, MD

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: crossover design according to the AB/BA scheme

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: June 18, 2024
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)