Clinical trial NCT04963140: Self-Management Of Asthma By Forced Oscillation Technique
Official title: Optimal Self-Management Of Asthma By Forced Oscillation Technique: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Lead sponsor: Restech Srl
Sponsor class: INDUSTRY
First posted: 2021-07-15
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Asthma Control
timeFrame: 6 months from enrolment
measure: Symptoms
timeFrame: From month no. 2 through study completion, an average of 7 months
Secondary outcomes:
measure: Asthma Control
timeFrame: 3 months from enrolment
measure: Asthma Control
timeFrame: 9 months from enrolment
measure: Asthma Control
timeFrame: 3 months from enrolment
measure: Asthma Control
timeFrame: 6 months from enrolment
measure: Asthma Control
timeFrame: 9 months from enrolment
measure: Asthma Control
timeFrame: 3 months from enrolment
measure: Asthma Control
timeFrame: 6 months from enrolment
measure: Asthma Control
timeFrame: 9 months from enrolment
measure: Asthma Control
timeFrame: 3 months from enrolment
measure: Asthma Control
timeFrame: 6 months from enrolment
measure: Asthma Control
timeFrame: 9 months from enrolment
measure: Exacerbation
timeFrame: Through study completion, an average of 9 months
measure: Controller medication usage
timeFrame: From month no. 2 through study completion, an average of 7 months
measure: Absence days from school/work
timeFrame: Through study completion, an average of 9 months
measure: Day-to-day variability of respiratory resistance
timeFrame: Through study completion, an average of 9 months
measure: Accuracy of CVRinsp in detecting exacerbations
timeFrame: Through study completion, an average of 9 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Woolcock Institute of Medical Research
city: Grenoble
country: France
facility: Grenoble University Hospital
city: Nancy
country: France
facility: University Children's Hospital of Nancy
city: Firenze
country: Italy
facility: Azienda Ospedaliero, Universitaria Meyer
state: FI
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti Ancona
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Palermo
country: Italy
facility: Istituto di Farmacologia Traslazionale (IFT) del CNR
city: Palermo
country: Italy
facility: Istituto di Farmacologia Traslazionale (IFT) del CNR
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico S. Matteo
city: Reggio Emilia
country: Italy
facility: Azienda Unità Sanitaria Locale di Reggio Emilia
Study officials:
References: