Self-Management Of Asthma By Forced Oscillation Technique

NCT04963140 | Unknown

• 1 other identifier: 1/20
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 10

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• Asthma Control

  Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)

  6 months from enrolment

• Symptoms

  Change of percentage of days with non-increased symptoms from baseline

  From month no. 2 through study completion, an average of 7 months

Secondary Outcomes (16)

• Asthma Control

  3 months from enrolment

• Asthma Control

  9 months from enrolment

• Asthma Control

  3 months from enrolment

• Asthma Control

  6 months from enrolment

• Asthma Control

  9 months from enrolment

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Optimized self-management of asthma

Control

SHAM COMPARATOR

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

Other: Conventional self-management of asthma

Interventions

Optimized self-management of asthma OTHER

Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) if an increased risk of asthma exacerbations is detected by the home monitoring device

Intervention

Conventional self-management of asthma OTHER

Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) is based on subject's self-perception of symptoms

Control

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of oral, rectal or parenteral glucocorticosteroids 30 days before enrolment
• Treatment with leukotriene receptor antagonist (LTRA)
• Treatment with maintenance and reliever therapy (SMART/MART)
• Smoking, current or previous with a history of 10 pack-years or more
• Documented COPD or other concomitant clinically important diseases or cognitive impairment that, according to the physician, may interfere with the subject's ability or safety to participate in the study
• Obesity (for subjects 6-19 years: BMI ≥ 95th percentile; for adults 20-65 years: BMI ≥ 40kg⋅m-2
• For school-age children (6-11 years old): gestational age at birth \< 37 weeks or documented bronchopulmonary dysplasia (BPD)
• Prolonged absence from home during the monitoring period (i.e. at recruitment, expected ≥3 consecutive weeks for ≥2 times during the 9- month monitoring period) Subject currently enrolled in other clinical trials related or involving the study of the respiratory system
• History of near-fatal asthma
• Women who are pregnant, nursing or intending to become pregnant during the time of the study
• Absence of health insurance coverage (applies to French centres only)

Sponsors & Collaborators

• Restech Srl: lead

Study Sites (10)

Woolcock Institute of Medical Research

Sydney, 2037, Australia

NOT YET RECRUITING

Grenoble University Hospital

Grenoble, 38043, France

RECRUITING

University Children's Hospital of Nancy

Nancy, 54500, France

RECRUITING

Azienda Ospedaliero, Universitaria Meyer

Florence, FI, 50139, Italy

RECRUITING

AOU Ospedali Riuniti Ancona

Ancona, 60126, Italy

RECRUITING

ASST Papa Giovanni XXIII

Bergamo, 24127, Italy

RECRUITING

Istituto di Farmacologia Traslazionale (IFT) del CNR

Palermo, 90146, Italy

NOT YET RECRUITING

Istituto di Farmacologia Traslazionale (IFT) del CNR

Palermo, 90146, Italy

NOT YET RECRUITING

Fondazione IRCCS Policlinico S. Matteo

Pavia, 27100, Italy

RECRUITING

Azienda Unità Sanitaria Locale di Reggio Emilia

Reggio Emilia, 42124, Italy

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Alessandro Gobbi, PhD

CONTACT

+390236593690; a.gobbi@restech.it

Pasquale Pio Pompilio, PhD

CONTACT

+390236593690; p.pompilio@restech.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 15, 2021
• Study Start: November 16, 2020
• Primary Completion: April 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 13, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); FR (2); IT (7)