Self-Management Of Asthma By Forced Oscillation Technique (PIANOFORTE)

RESTECH

Status: Enrolling

Conditions: Asthma

Treatments: Other: Optimized self-management of asthma; Other: Conventional self-management of asthma

Study type: Interventional

Funder types: Industry

Identifiers

NCT04963140

1/20

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 6 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Other: Optimized self-management of asthma

Control

Sham Comparator group

Description:

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

Treatment:

Other: Conventional self-management of asthma