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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02034305
Other study ID # PRO11100704
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date January 1, 2021

Study information

Verified date January 2021
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is to determine whether physiologic measures (peak cough flow, measures of respiratory muscle strength including MIP, MEP ,SNIP, and spirometry) can predict spontaneous cough clearance (as measured by a nuclear medicine study) in children with neuromuscular disease. It will also determine whether airway clearance is augmented by high frequency chest wall oscillation.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date January 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender Male
Age group 6 Years to 21 Years
Eligibility Inclusion Criteria: - Age 6-21; able to cooperate with study procedures - Duchenne Muscular Dystrophy OR Becker Muscular Dystrophy Exclusion Criteria: - Need for mechanical ventilation during the day - Recent (within 2 weeks) lower respiratory tract infection

Study Design


Locations

Country Name City State
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh Respirtech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Spontaneous cough clearance Assessed at multiple time points over 30 minutes
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