NCT02034305

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 5, 2024

Status Verified

January 1, 2021

Enrollment Period

7 years

First QC Date

January 9, 2014

Last Update Submit

February 2, 2024

Conditions

Duchenne Muscular Dystrophy

Keywords

Airway ClearanceDuchenne Muscular DystrophyPeak Cough Flow

Outcome Measures

Primary Outcomes (1)

  • Spontaneous cough clearance

    Assessed at multiple time points over 30 minutes

Eligibility Criteria

Age6 Years - 21 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Boys 6-21 years of age with Duchenne Muscular Dystrophy

You may qualify if:

  • Age 6-21; able to cooperate with study procedures
  • Duchenne Muscular Dystrophy OR Becker Muscular Dystrophy

You may not qualify if:

  • Need for mechanical ventilation during the day
  • Recent (within 2 weeks) lower respiratory tract infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (1)

  • Weiner DJ, Abdel-Hamid H, Corcoran TE. Pilot study of nuclear scintigraphy to assess cough clearance in DMD. Pediatr Pulmonol. 2022 Jul;57(7):1776-1778. doi: 10.1002/ppul.25894. Epub 2022 May 5. No abstract available.

    PMID: 35293696DERIVED

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 13, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

February 5, 2024

Record last verified: 2021-01

Locations

US(1)