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

February 10, 2023 updated by: Restech Srl

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control
Time Frame: 6 months from enrolment
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
6 months from enrolment
Symptoms
Time Frame: From month no. 2 through study completion, an average of 7 months
Change of percentage of days with non-increased symptoms from baseline
From month no. 2 through study completion, an average of 7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control
Time Frame: 3 months from enrolment
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
3 months from enrolment
Asthma Control
Time Frame: 9 months from enrolment
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
9 months from enrolment
Asthma Control
Time Frame: 3 months from enrolment
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
3 months from enrolment
Asthma Control
Time Frame: 6 months from enrolment
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
6 months from enrolment
Asthma Control
Time Frame: 9 months from enrolment
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5) moving from uncontrolled to controlled asthma
9 months from enrolment
Asthma Control
Time Frame: 3 months from enrolment
Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
3 months from enrolment
Asthma Control
Time Frame: 6 months from enrolment
Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
6 months from enrolment
Asthma Control
Time Frame: 9 months from enrolment
Change of percentage of adolescent and adult subjects (12+ years old) who improve their Asthma Control Questionnaire (ACQ-5)
9 months from enrolment
Asthma Control
Time Frame: 3 months from enrolment
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
Asthma Control
Time Frame: 6 months from enrolment
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
Asthma Control
Time Frame: 9 months from enrolment
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
Exacerbation
Time Frame: Through study completion, an average of 9 months
Change of number of moderate and severe exacerbations
Through study completion, an average of 9 months
Controller medication usage
Time Frame: From month no. 2 through study completion, an average of 7 months
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
Absence days from school/work
Time Frame: Through study completion, an average of 9 months
Change of absence days from work/school due to asthma
Through study completion, an average of 9 months
Day-to-day variability of respiratory resistance
Time Frame: Through study completion, an average of 9 months
Change of average day-to-day coefficient of variation of inspiratory resistance (CVRinsp)
Through study completion, an average of 9 months
Accuracy of CVRinsp in detecting exacerbations
Time Frame: Through study completion, an average of 9 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Restech Srl

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 16, 2020

Primary Completion (ANTICIPATED)

April 1, 2024

Study Completion (ANTICIPATED)

September 1, 2024

Study Registration Dates

First Submitted

June 18, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (ACTUAL)

July 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No Individual Participant Data (IPD) sharing planned at this stage

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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