Ignite Creation Date:
2024-07-17 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482294
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-25
Brief Title:
CIVETTA Correlating Inflammatory Values of FEno SympToms SpuTum and Lung Function in Asthma
Sponsor:
Università degli Studi di Ferrara
Organization:
Università degli Studi di Ferrara
Study Overview
Official Title:
CIVETTA Correlating Inflammatory Values of FEno SympToms SpuTum and Lung Function in Asthma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n50 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 ABBA scheme it will be assessed whether there are differences in the airway inflammation profile in patients n30 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
- 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 n50 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 ABBA scheme it will be assessed whether there are differences in the airway inflammation profile in patients n30 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None