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OpenTrials
Terminated

NCT Number: NCT04963140

Self-Management Of Asthma By Forced Oscillation Technique

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.

Why the study stopped: The study was terminated early due to an unexpected difficulty at the study sites in recruiting patients who met all the inclusion criteria.
Terminated

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Key information

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Woolcock Institute of Medical Research, Sydney, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Optimized self-management of asthma

Other

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

Other

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

Primary outcomes

  1. Asthma Control

    Time frame: 6 months from enrolment

    Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)

  2. 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

Secondary outcomes

  1. Asthma Control

    Time frame: 3 months from enrolment

    Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)

  2. Asthma Control

    Time frame: 9 months from enrolment

    Change of percentage of subjects who improve their Asthma Control Questionnaire (ACQ-5)

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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)

  8. 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. 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

  10. 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

  11. 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

  12. Exacerbation

    Time frame: Through study completion, an average of 9 months

    Change of number of moderate and severe exacerbations

  13. 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))

  14. 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

  15. 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)

  16. 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

Sponsors and collaborators

Lead sponsor

Restech Srl

Industry

Registry information

Official study title

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

Acronym: PIANOFORTE

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2021
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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