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Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT04084041
Recruitment Status : Completed
First Posted : September 10, 2019
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Physio-Assist

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis in Children Airway Clearance Impairment Device: Simeox Other: CCPT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of the Simeox Airway Clearance Technology in the Treatment of Children With Clinically Stable Cystic Fibrosis- Cross-over Study With Randomization
Actual Study Start Date : September 10, 2019
Actual Primary Completion Date : January 31, 2021
Actual Study Completion Date : February 15, 2021


Arm Intervention/treatment
Experimental: Device
Device group
Device: Simeox
Airway clearance device

Other: CCPT
Conventional chest physiotherapy

Active Comparator: Conventional chest physiotherapy
Control group
Device: Simeox
Airway clearance device

Other: CCPT
Conventional chest physiotherapy




Primary Outcome Measures :
  1. Change in total lung resistance [ Time Frame: 1 month ]
    Evolution of R5hz - Impulse Oscillometry (IOS) from baseline


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084041


Locations
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Poland
IMiD
Warsaw, Poland
Sponsors and Collaborators
Physio-Assist
Investigators
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Principal Investigator: Dorota Sands, MD, PhD IMiD
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Responsible Party: Physio-Assist
ClinicalTrials.gov Identifier: NCT04084041    
Other Study ID Numbers: HOMECARE_CF
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: March 1, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Physio-Assist:
Airway clearance technique
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases