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Completed

NCT Number: NCT04084041

Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

Chest physiotherapy plays a crucial role in treatment of lung disease in cystic fibrosis (CF). New airway clearance techniques (ACTs) adapted to individual needs are still being sought to achieve the best effect of airway clearance. The primary aim of this study is to assess the efficacy of a new ACT (Simeox) on pulmonary function in children with CF. 40 CF patients with stable respiratory function will be randomized 1:1 to Simeox or conventional chest physiotherapy (CCPT) therapy (control group) and treated at home during 1 month. After a short washout period, patients will be treated at home onto the alternative treatment for 1 month (crossover design). Lung function, quality of life, pulmonary exacerbation and safety will be evaluated at 1 month for each therapy period.

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Key information

Conditions

Cystic Fibrosis in Children Airway Clearance Impairment

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IMiD

Warsaw, Poland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject and his or her legally appointed and authorized representative will agree for treatment with Simeox technology
  • willing and able to cooperate and learn new technic of drainage.
  • age 8-18 years, on the date of admission to hospital.
  • confirmed diagnosis of CF as determined by the investigator.
  • able to perform pulmonary tests

Exclusion criteria

History of any illness or any clinical condition that, in the opinion of the investigator, might confound the cooperation or the results of the study or pose an additional risk to the subject in using study technology. This includes, but is not limited to, the following:

  • contraindications to bronchial chest physiotherapy
  • hemoptysis
  • pneumothorax
  • heart disease
  • recent chest surgery
  • recent chest injury
  • history of lung transplantation

Treatment and study plan

Simeox

Device

Airway clearance device

CCPT

Other

Conventional chest physiotherapy

Primary outcomes

  1. Change in total lung resistance

    Time frame: 1 month

    Evolution of R5hz - Impulse Oscillometry (IOS) from baseline

Secondary outcomes

  1. Change in central lung resistance

    Time frame: 1 month

    Evolution of R20hz - Impulse Oscillometry (IOS) from baseline

  2. Change in peripheral lung resistance

    Time frame: 1 month

    Evolution of R5-20hz - Impulse Oscillometry (IOS) from baseline

  3. Change in total lung reactance

    Time frame: 1 month

    Evolution of X5hz -Impulse Oscillometry (IOS) from baseline

  4. Change in area of reactance (AX)

    Time frame: 1 month

    Evolution of AX -Impulse Oscillometry (IOS) from baseline

  5. Change in total score of Cystic Fibrosis Questionnaire-Revised (CFQ-R)

    Time frame: 1 month

    Evolution of CFQ-R total score (0-100) from baseline

  6. Change in respiratory domain score of Cystic Fibrosis Questionnaire Revised (CFQ-R) questionnaire

    Time frame: 1 month

    Evolution of respiratory score (0-100) of CFQ-R from baseline

  7. Change in Forced Expiratory Volume in 1 second (FEV1)

    Time frame: 1 month

    Evolution of FEV1 (spirometry) from baseline

  8. Change in Forced Vital Capacity (FVC)

    Time frame: 1 month

    Evolution of FVC (spirometry) from baseline

  9. Change in Residual Volume (RV)

    Time frame: 1 month

    Evolution of RV (body plethysmography) from baseline

  10. Change in Maximal Expiratory Flow (MEF) at 25, 50 and 75% of expired volume

    Time frame: 1 month

    Evolution of MEF 25, 50 and 75 (spirometry) from baseline

  11. Change in Mean Mid Expiratory Flow (MMEF)

    Time frame: 1 month

    Evolution of MMEF (spirometry) from baseline

  12. Change in lung clearance index (LCI)

    Time frame: 1 month

    Evolution of LCI with Nitrogen multiple breath washout (N2MBW) tests from baseline

  13. Pulmonary exacerbation

    Time frame: 1 month

    Rate of pulmonary exacerbation

  14. Adverse events

    Time frame: 1 month

    Rate of adverse events related or not related to intervention

Sponsors and collaborators

Lead sponsor

Physio-Assist

Industry

Registry information

Official study title

Efficacy of the Simeox Airway Clearance Technology in the Treatment of Children With Clinically Stable Cystic Fibrosis- Cross-over Study With Randomization

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 10, 2019
Registry last updated
Sep 24, 2025

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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