Optimal Self-Management Of Asthma By Forced Oscillation Technique: a Randomised Controlled Trial

Status: Unknown
Location: See all (10) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Self-management strategies for asthma, including patients engagement and adherence to personalised action plans with advice on recognizing and responding to deterioration in control with effective treatments can improve asthma outcomes and possibly reduce the risk of future exacerbations. However, the real-life evidence is that asthma control remains sub-optimal in the majority of cases, thus increasing the related socio-economic costs worldwide. Because an increased variability of lung function remains a hallmark of poor asthma control and exacerbations, its assessment over time could contribute to the success of self-management plans. Previous studies have shown the potential of Forced Oscillation Technique (FOT) as a tool for monitoring increased variability of airway obstruction and for identifying the onset of acute deterioration of airway function. The aim of this study is to test the hypothesis that a personalised self-management plan including FOT improves asthma control and reduces number of days with increased symptoms compared to conventional asthma treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 65
Healthy Volunteers: f
View:

• Age: 6-65 years old

• Diagnosis of persistent asthma

• Treatment level at study entry:

‣ For children 6-11 years: Step2 or Step3 of the GINA document

⁃ For adolescents and adults 12-65 years: Step2 under daily low-dose inhaled corticosteroids (ICS), Step 3 or Step 4 of the GINA document

• Uncontrolled asthma (ACQ-5 \> 1.5) that, according to the physician, does not warrant an immediate step-up of the treatment

• History of moderate or severe exacerbations in the twelve (12) months prior to baseline visit

Locations
Other Locations
Australia
Woolcock Institute of Medical Research
NOT_YET_RECRUITING
Sydney
France
Grenoble University Hospital
RECRUITING
Grenoble
University Children's Hospital of Nancy
RECRUITING
Nancy
Italy
AOU Ospedali Riuniti Ancona
RECRUITING
Ancona
ASST Papa Giovanni XXIII
RECRUITING
Bergamo
Azienda Ospedaliero, Universitaria Meyer
RECRUITING
Florence
Istituto di Farmacologia Traslazionale (IFT) del CNR
NOT_YET_RECRUITING
Palermo
Istituto di Farmacologia Traslazionale (IFT) del CNR
NOT_YET_RECRUITING
Palermo
Fondazione IRCCS Policlinico S. Matteo
RECRUITING
Pavia
Azienda Unità Sanitaria Locale di Reggio Emilia
RECRUITING
Reggio Emilia
Contact Information
Primary
Alessandro Gobbi, PhD
a.gobbi@restech.it
+390236593690
Backup
Pasquale Pio Pompilio, PhD
p.pompilio@restech.it
+390236593690
Time Frame
Start Date: 2020-11-16
Completion Date: 2024-09
Participants
Target number of participants: 200
Treatments
Experimental: Intervention
Intervention subjects will monitor their lung function daily by Forced Oscillation Technique (FOT) device. The embedded algorithm signals when an increased risk of exacerbation is detected and subjects shall modify their treatment based on the action plan prescribed by the study doctor at enrolment and used for the self-management of their asthma
Sham_comparator: Control
Control subjects will monitor their lung function daily by Forced Oscillation Technique (FOT) device. The embedded algorithm used in the intervention arm is disabled. Subjects will follow the action plan prescribed by the study doctor at enrolment for the self-management of their asthma
Related Therapeutic Areas
Sponsors
Leads: Restech Srl

This content was sourced from clinicaltrials.gov