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

NCT06482294 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-07-03

No results posted yet for this study

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

Interventions

DRUG

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).

DRUG

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).

Sponsors & Collaborators

  • Università degli Studi di Ferrara

    lead OTHER

Principal Investigators

  • Alberto Papi, MD · Università degli Studi di Ferrara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-18
Primary Completion
2025-05-01
Completion
2025-07-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06482294 on ClinicalTrials.gov