Lung Volume Recruitment for Lung Function and Cough Impairment in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Lung Volume Recruitment for Lung Function and Cough Impairment in Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01891071
• Other study ID #: MS-LVR-01
• Secondary ID: 20120570-01HAA-H
• Status: Recruiting
• Phase: N/A
• First received: February 25, 2013
• Last updated: April 20, 2015
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Multiple sclerosis is a neurological disease that can affect lung function and cough efficacy. This pilot study will examine whether the lung volume recruitment technique can slow down the decline in lung function and cough.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• History of multiple sclerosis, diagnosed by a neurologist in accordance with the 2010 McDonald criteria

Exclusion Criteria:

• Concomitant parenchymal pulmonary disease or pleural disease

• Symptomatic cardiomyopathy

• Unable to perform pulmonary function testing or lung volume recruitment, due to comprehension or cooperation issues, physical inability such as bulbar or cerebellar dysfunction

• Contra-indication to pulmonary function testing or lung volume recruitment such as myocardial infarction, bleeding aortic aneurysm, intracranial hemorrhage within the previous month

• Known susceptibility to pneumothorax or pneumomediastinum

• Not competent to provide informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Procedure:
• Lung volume recruitment
Inflation of the lungs to their maximal insufflation capacity by the consecutive delivery, by a manual resuscitator in this study, of volumes of air that are held with a closed glottis

Locations

Country	Name	City	State
Canada	Hôpital Charles-LeMoyne	Greenfield Park	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	The Ottawa Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Srour N, LeBlanc C, King J, McKim DA. Lung volume recruitment in multiple sclerosis. PLoS One. 2013;8(1):e56676. doi: 10.1371/journal.pone.0056676. Epub 2013 Jan 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of decline of FVC (forced vital capacity)		up to 9 months	No
Secondary	Rate of decline of peak cough flow		baseline, 2, 4, 6 and 9 months	No
Secondary	Change from baseline in FVC at 2, 4, 6 and 9 months		baseline vs 2, 4, 6 and 9 months	No
Secondary	Change from baseline in peak cough flow at 2, 4, 6 and 9 months		baseline vs 2, 4, 6 and 9 months	No