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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04963140




Registration number
NCT04963140
Ethics application status
Date submitted
18/06/2021
Date registered
15/07/2021

Titles & IDs
Public title
Self-Management Of Asthma By Forced Oscillation Technique
Scientific title
Optimal Self-Management Of Asthma By Forced Oscillation Technique: a Randomised Controlled Trial
Secondary ID [1] 0 0
1/20
Universal Trial Number (UTN)
Trial acronym
PIANOFORTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Optimized self-management of asthma
Other interventions - Conventional self-management of asthma

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

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 interventions: 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

Other interventions: 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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Asthma Control
Timepoint [1] 0 0
6 months from enrolment
Primary outcome [2] 0 0
Symptoms
Timepoint [2] 0 0
From month no. 2 through study completion, an average of 7 months
Secondary outcome [1] 0 0
Asthma Control
Timepoint [1] 0 0
3 months from enrolment
Secondary outcome [2] 0 0
Asthma Control
Timepoint [2] 0 0
9 months from enrolment
Secondary outcome [3] 0 0
Asthma Control
Timepoint [3] 0 0
3 months from enrolment
Secondary outcome [4] 0 0
Asthma Control
Timepoint [4] 0 0
6 months from enrolment
Secondary outcome [5] 0 0
Asthma Control
Timepoint [5] 0 0
9 months from enrolment
Secondary outcome [6] 0 0
Asthma Control
Timepoint [6] 0 0
3 months from enrolment
Secondary outcome [7] 0 0
Asthma Control
Timepoint [7] 0 0
6 months from enrolment
Secondary outcome [8] 0 0
Asthma Control
Timepoint [8] 0 0
9 months from enrolment
Secondary outcome [9] 0 0
Asthma Control
Timepoint [9] 0 0
3 months from enrolment
Secondary outcome [10] 0 0
Asthma Control
Timepoint [10] 0 0
6 months from enrolment
Secondary outcome [11] 0 0
Asthma Control
Timepoint [11] 0 0
9 months from enrolment
Secondary outcome [12] 0 0
Exacerbation
Timepoint [12] 0 0
Through study completion, an average of 9 months
Secondary outcome [13] 0 0
Controller medication usage
Timepoint [13] 0 0
From month no. 2 through study completion, an average of 7 months
Secondary outcome [14] 0 0
Absence days from school/work
Timepoint [14] 0 0
Through study completion, an average of 9 months
Secondary outcome [15] 0 0
Day-to-day variability of respiratory resistance
Timepoint [15] 0 0
Through study completion, an average of 9 months
Secondary outcome [16] 0 0
Accuracy of CVRinsp in detecting exacerbations
Timepoint [16] 0 0
Through study completion, an average of 9 months

Eligibility
Key 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
Minimum age
6 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Sydney
Recruitment postcode(s) [1] 0 0
2037 - Sydney
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Grenoble
Country [2] 0 0
France
State/province [2] 0 0
Nancy
Country [3] 0 0
Italy
State/province [3] 0 0
FI
Country [4] 0 0
Italy
State/province [4] 0 0
Ancona
Country [5] 0 0
Italy
State/province [5] 0 0
Bergamo
Country [6] 0 0
Italy
State/province [6] 0 0
Palermo
Country [7] 0 0
Italy
State/province [7] 0 0
Pavia
Country [8] 0 0
Italy
State/province [8] 0 0
Reggio Emilia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Restech Srl
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alessandro Gobbi, PhD
Address 0 0
Country 0 0
Phone 0 0
+390236593690
Fax 0 0
Email 0 0
a.gobbi@restech.it
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No Individual Participant Data (IPD) sharing planned at this stage


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04963140