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Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis in Children, Airway Clearance Impairment

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Simeox
CCPT
Sponsored by
Physio-Assist
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis in Children focused on measuring Airway clearance technique

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IMiD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Device

Conventional chest physiotherapy

Arm Description

Device group

Control group

Outcomes

Primary Outcome Measures

Change in total lung resistance
Evolution of R5hz - Impulse Oscillometry (IOS) from baseline

Secondary Outcome Measures

Change in central lung resistance
Evolution of R20hz - Impulse Oscillometry (IOS) from baseline
Change in peripheral lung resistance
Evolution of R5-20hz - Impulse Oscillometry (IOS) from baseline
Change in total lung reactance
Evolution of X5hz -Impulse Oscillometry (IOS) from baseline
Change in area of reactance (AX)
Evolution of AX -Impulse Oscillometry (IOS) from baseline
Change in total score of Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Evolution of CFQ-R total score (0-100) from baseline
Change in respiratory domain score of Cystic Fibrosis Questionnaire Revised (CFQ-R) questionnaire
Evolution of respiratory score (0-100) of CFQ-R from baseline
Change in Forced Expiratory Volume in 1 second (FEV1)
Evolution of FEV1 (spirometry) from baseline
Change in Forced Vital Capacity (FVC)
Evolution of FVC (spirometry) from baseline
Change in Residual Volume (RV)
Evolution of RV (body plethysmography) from baseline
Change in Maximal Expiratory Flow (MEF) at 25, 50 and 75% of expired volume
Evolution of MEF 25, 50 and 75 (spirometry) from baseline
Change in Mean Mid Expiratory Flow (MMEF)
Evolution of MMEF (spirometry) from baseline
Change in lung clearance index (LCI)
Evolution of LCI with Nitrogen multiple breath washout (N2MBW) tests from baseline
Pulmonary exacerbation
Rate of pulmonary exacerbation
Adverse events
Rate of adverse events related or not related to intervention

Full Information

First Posted
September 5, 2019
Last Updated
February 26, 2021
Sponsor
Physio-Assist
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1. Study Identification

Unique Protocol Identification Number
NCT04084041
Brief Title
Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis
Official Title
Efficacy of the Simeox Airway Clearance Technology in the Treatment of Children With Clinically Stable Cystic Fibrosis- Cross-over Study With Randomization
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Physio-Assist

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis in Children, Airway Clearance Impairment
Keywords
Airway clearance technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device
Arm Type
Experimental
Arm Description
Device group
Arm Title
Conventional chest physiotherapy
Arm Type
Active Comparator
Arm Description
Control group
Intervention Type
Device
Intervention Name(s)
Simeox
Intervention Description
Airway clearance device
Intervention Type
Other
Intervention Name(s)
CCPT
Intervention Description
Conventional chest physiotherapy
Primary Outcome Measure Information:
Title
Change in total lung resistance
Description
Evolution of R5hz - Impulse Oscillometry (IOS) from baseline
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Change in central lung resistance
Description
Evolution of R20hz - Impulse Oscillometry (IOS) from baseline
Time Frame
1 month
Title
Change in peripheral lung resistance
Description
Evolution of R5-20hz - Impulse Oscillometry (IOS) from baseline
Time Frame
1 month
Title
Change in total lung reactance
Description
Evolution of X5hz -Impulse Oscillometry (IOS) from baseline
Time Frame
1 month
Title
Change in area of reactance (AX)
Description
Evolution of AX -Impulse Oscillometry (IOS) from baseline
Time Frame
1 month
Title
Change in total score of Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Description
Evolution of CFQ-R total score (0-100) from baseline
Time Frame
1 month
Title
Change in respiratory domain score of Cystic Fibrosis Questionnaire Revised (CFQ-R) questionnaire
Description
Evolution of respiratory score (0-100) of CFQ-R from baseline
Time Frame
1 month
Title
Change in Forced Expiratory Volume in 1 second (FEV1)
Description
Evolution of FEV1 (spirometry) from baseline
Time Frame
1 month
Title
Change in Forced Vital Capacity (FVC)
Description
Evolution of FVC (spirometry) from baseline
Time Frame
1 month
Title
Change in Residual Volume (RV)
Description
Evolution of RV (body plethysmography) from baseline
Time Frame
1 month
Title
Change in Maximal Expiratory Flow (MEF) at 25, 50 and 75% of expired volume
Description
Evolution of MEF 25, 50 and 75 (spirometry) from baseline
Time Frame
1 month
Title
Change in Mean Mid Expiratory Flow (MMEF)
Description
Evolution of MMEF (spirometry) from baseline
Time Frame
1 month
Title
Change in lung clearance index (LCI)
Description
Evolution of LCI with Nitrogen multiple breath washout (N2MBW) tests from baseline
Time Frame
1 month
Title
Pulmonary exacerbation
Description
Rate of pulmonary exacerbation
Time Frame
1 month
Title
Adverse events
Description
Rate of adverse events related or not related to intervention
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorota Sands, MD, PhD
Organizational Affiliation
IMiD
Official's Role
Principal Investigator
Facility Information:
Facility Name
IMiD
City
Warsaw
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

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