Efficacy of Simeox Airway Clearance Therapy in Children With Cystic Fibrosis

• Sponsor: Physio-Assist (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04084041
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.2
• Patients Per Site Per Month: 2.3

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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: Sep 10, 2019
• Actual Primary Completion Date: Jan 31, 2021
• Actual Study Completion Date: Feb 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 [1 month]

   Evolution of R5hz - Impulse Oscillometry (IOS) from baseline

Secondary Outcome Measures

1. Change in central lung resistance [1 month]

   Evolution of R20hz - Impulse Oscillometry (IOS) from baseline

2. Change in peripheral lung resistance [1 month]

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

3. Change in total lung reactance [1 month]

   Evolution of X5hz -Impulse Oscillometry (IOS) from baseline

4. Change in area of reactance (AX) [1 month]

   Evolution of AX -Impulse Oscillometry (IOS) from baseline

5. Change in total score of Cystic Fibrosis Questionnaire-Revised (CFQ-R) [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 [1 month]

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

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

   Evolution of FEV1 (spirometry) from baseline

8. Change in Forced Vital Capacity (FVC) [1 month]

   Evolution of FVC (spirometry) from baseline

9. Change in Residual Volume (RV) [1 month]

   Evolution of RV (body plethysmography) from baseline

10. Change in Maximal Expiratory Flow (MEF) at 25, 50 and 75% of expired volume [1 month]

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

11. Change in Mean Mid Expiratory Flow (MMEF) [1 month]

    Evolution of MMEF (spirometry) from baseline

12. Change in lung clearance index (LCI) [1 month]

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

13. Pulmonary exacerbation [1 month]

    Rate of pulmonary exacerbation

14. Adverse events [1 month]

    Rate of adverse events related or not related to intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	IMiD	Warsaw		Poland

Sponsors and Collaborators

• Physio-Assist

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Mar 1, 2021