Self-Management Of Asthma By Forced Oscillation Technique

Asthma Clinical Trial

— PIANOFORTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963140
• Other study ID #: 1/20
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: September 2024

Study information

• Verified date: November 2022
• Source: Restech Srl
• Contact: Alessandro Gobbi, PhD
• Phone: +390236593690
• Email: a.gobbi[@]restech.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Australia	Woolcock Institute of Medical Research	Sydney
France	Grenoble University Hospital	Grenoble
France	University Children's Hospital of Nancy	Nancy
Italy	AOU Ospedali Riuniti Ancona	Ancona
Italy	ASST Papa Giovanni XXIII	Bergamo
Italy	Azienda Ospedaliero, Universitaria Meyer	Firenze	FI
Italy	Istituto di Farmacologia Traslazionale (IFT) del CNR	Palermo
Italy	Istituto di Farmacologia Traslazionale (IFT) del CNR	Palermo
Italy	Fondazione IRCCS Policlinico S. Matteo	Pavia
Italy	Azienda Unità Sanitaria Locale di Reggio Emilia	Reggio Emilia

Sponsors (1)

Lead Sponsor	Collaborator
Restech Srl

Countries where clinical trial is conducted

Australia,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control	Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)	6 months from enrolment
Primary	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	Asthma Control	Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)	3 months from enrolment
Secondary	Asthma Control	Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)	9 months from enrolment
Secondary	Asthma Control	Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma	3 months from enrolment
Secondary	Asthma Control	Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma	6 months from enrolment
Secondary	Asthma Control	Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma	9 months from enrolment
Secondary	Asthma Control	Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)	3 months from enrolment
Secondary	Asthma Control	Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)	6 months from enrolment
Secondary	Asthma Control	Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)	9 months from enrolment
Secondary	Asthma Control	Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome	3 months from enrolment
Secondary	Asthma Control	Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome	6 months from enrolment
Secondary	Asthma Control	Change of mean Asthma Control Questionnaire (ACQ-5); the expected ACQ-5 range is 0 - 3.5, with lower values indicating better asthma outcome	9 months from enrolment
Secondary	Exacerbation	Change of number of moderate and severe exacerbations	Through study completion, an average of 9 months
Secondary	Controller medication usage	Change of days with increased controller (inhaled corticosteroid (ICS) alone or in combination with long-acting bronchodilator (LABA))	From month no. 2 through study completion, an average of 7 months
Secondary	Absence days from school/work	Change of absence days from work/school due to asthma	Through study completion, an average of 9 months
Secondary	Day-to-day variability of respiratory resistance	Change of average day-to-day coefficient of variation of inspiratory resistance (CVRinsp)	Through study completion, an average of 9 months
Secondary	Accuracy of CVRinsp in detecting exacerbations	In the control arm of the study only: accuracy, sensitivity and specificity of day-to-day variability of FOT parameters and of related prediction algorithm in identifying the occurrence of future moderate and severe exacerbations	Through study completion, an average of 9 months