Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

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

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Poland

IMiD

Warsaw, Poland

Sponsors and Collaborators

Physio-Assist

Investigators

• Principal Investigator: Dorota Sands, MD, PhD; IMiD

More Information

• Responsible Party: Physio-Assist
• ClinicalTrials.gov Identifier: NCT04084041
• Other Study ID Numbers: HOMECARE_CF
• First Posted: September 10, 2019
• Last Update Posted: March 1, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Cystic Fibrosis; Fibrosis; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases