NCT04963140Terminated
Self-Management Of Asthma By Forced Oscillation Technique
Optimal Self-Management Of Asthma By Forced Oscillation Technique: a Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 18 Jun 2021
- Start date
- 16 Nov 2020
- Primary completion date
- 24 Apr 2024
- Lead sponsor
- Restech Srl
- Diseases
- Asthma
- NCT number
- NCT04963140
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of near-fatal asthma
Age
- For school-age children (6-11 years old): gestational age at birth \< 37 weeks or documented bronchopulmonary dysplasia (BPD)
Other
- Obesity (for subjects 6-19 years: BMI ≥ 95th percentile; for adults 20-65 years: BMI ≥ 40kg⋅m-2
- 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
- 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)
Who the study is looking for
- 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
Age in the registry: 6 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Woolcock Institute of Medical Research Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Grenoble University Hospital Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| University Children's Hospital of Nancy Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| AOU Ospedali Riuniti Ancona Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Asst Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria Meyer Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Istituto di Farmacologia Traslazionale (IFT) del CNR Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Fondazione IRCCS Policlinico S. Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Azienda Unita Sanitaria Locale Di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.