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NCT04963140Leállítva

Self-Management Of Asthma By Forced Oscillation Technique

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 26.

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

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Leállítva
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
39 (tényleges)
Első benyújtás
2021. jún. 18.
Kezdés
2020. nov. 16.
Elsődleges befejezés
2024. ápr. 24.
Fő szponzor
Restech Srl
Betegségek
Asztma
NCT-szám
NCT04963140

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Korábbi kezelés

  • 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

Más betegség

  • History of near-fatal asthma

Életkor

  • For school-age children (6-11 years old): gestational age at birth < 37 weeks or documented bronchopulmonary dysplasia (BPD)

Egyéb

  • 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)

Kiket keres a vizsgálat

  • 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

Életkor a regiszterben: 6 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (9)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Woolcock Institute of Medical ResearchSydneyAusztráliaIsmeretlen állapot
Grenoble University HospitalGrenobleFranciaországIsmeretlen állapot
University Children's Hospital of NancyNancyFranciaországIsmeretlen állapot
AOU Ospedali Riuniti AnconaAnconaOlaszországIsmeretlen állapot
Asst Papa Giovanni XXIIIBergamoOlaszországIsmeretlen állapot
Azienda Ospedaliero-Universitaria MeyerFlorenceOlaszországIsmeretlen állapot
Istituto di Farmacologia Traslazionale (IFT) del CNRPalermoOlaszországIsmeretlen állapot
Fondazione IRCCS Policlinico S. MatteoPaviaOlaszországIsmeretlen állapot
Azienda Unita Sanitaria Locale Di Reggio EmiliaReggio EmiliaOlaszországIsmeretlen állapot

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