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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04563832




Registration number
NCT04563832
Ethics application status
Date submitted
21/09/2020
Date registered
24/09/2020
Date last updated
12/04/2022

Titles & IDs
Public title
Self-administered Hyperinsufflation Chest on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit
Scientific title
Self-administered Hyperinsufflation Chest Mobilization Randomized Study on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit
Secondary ID [1] 0 0
APHP2020
Universal Trial Number (UTN)
Trial acronym
MS-COUGH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Standardized respiratory management program
Other interventions - CoughAssist

Other: Control group - standardized respiratory management.

Experimental: Experimental group - same program as control group associated with the daily use of a hyperinsufflation technique (2 times per day during15 minutes, 5 days a week, for 2 years)


Other interventions: Standardized respiratory management program
Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years

Other interventions: CoughAssist
self-administered mechanical in-exsufflation - CoughAssist (2 x 15 min per day, 5 days per week for 2 years)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effectiveness of a self-administered automated hyperinsufflation technique for 2 years, versus standard management, on respiratory infection risk within 2 years after randomization, in patients with MS.
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Effect of COUGH-ASSIST on slowing the decline in respiratory function,
Timepoint [1] 0 0
12 months and 24 months
Secondary outcome [2] 0 0
Functional effectiveness of COUGH-ASSIST
Timepoint [2] 0 0
12 months and 24 months
Secondary outcome [3] 0 0
Tolerance and compliance with COUGH-ASSIST,
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Effectiveness of COUGH-ASSIST in reducing the risk of serious respiratory infection
Timepoint [4] 0 0
24 months

Eligibility
Key inclusion criteria
- Confirmed MS diagnosis (McDonald criteria)

- EDSS = 7

- Age greater than or equal to 18 years.

- Expiratory flow during a coughing effort (DEPtoux) ?4.5L / s.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- ENT and / or thoracic surgery less than 6 months old

- Progressive or past pneumothorax / pneumomediastinum

- Severe swallowing disorders.

- Inability to use the device under study

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2022
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Haut De Seine

Funding & Sponsors
Primary sponsor type
Other
Name
Assistance Publique - Hôpitaux de Paris
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
In patients with neuromuscular disease, chest mobilization by hyperinsufflation slows
respiratory decline by almost 80% compared to controls, and prevents complications like
pneumonia, atelectasis and respiratory distress.

This insufflation technique improves the airway clearance and reduces the need for invasive
ventilation. It also improves CV and DEPtoux in patients with neuromuscular pathology
Trial website
https://clinicaltrials.gov/ct2/show/NCT04563832
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jonathan LEVY, Dr
Address 0 0
Country 0 0
Phone 0 0
+33 147107900
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04563832