Optimized self-management of asthma
OtherShort-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
NCT Number: NCT04963140
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.
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Notify Me6 year–65 year
All sexes
Interventional
Not applicable
Woolcock Institute of Medical Research, Sydney, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) is based on subject's self-perception of symptoms
Time frame: 6 months from enrolment
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
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
Time frame: 3 months from enrolment
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
Time frame: 9 months from enrolment
Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)
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
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
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
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)
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)
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)
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
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
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
Time frame: Through study completion, an average of 9 months
Change of number of moderate and severe exacerbations
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))
Time frame: Through study completion, an average of 9 months
Change of absence days from work/school due to asthma
Time frame: Through study completion, an average of 9 months
Change of average day-to-day coefficient of variation of inspiratory resistance (CVRinsp)
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
Restech Srl
Industry
Optimal Self-Management Of Asthma By Forced Oscillation Technique: a Randomised Controlled Trial
Acronym: PIANOFORTE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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