Peak Cough Flow and Cough Clearance in Patients With Musc... | NCT02034305

Studies
Peak Cough Flow and Cough Clearance in Patients With Muscular Dystrophy

NCT02034305

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Feb 5, 2024Actual

Enrollment

7Actual

Phase

Not provided

Conditions

Duchenne Muscular Dystrophy

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Jan 1, 2021Actual

First Submitted Date

Jan 9, 2014

First Submission Date that Met QC Criteria

Jan 10, 2014

First Posted Date

Jan 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2024

Last Update Posted Date

Feb 5, 2024Actual

Name	Class
Respirtech, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spontaneous cough clearance		Assessed at multiple time points over 30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Boys 6-21 years of age with Duchenne Muscular Dystrophy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Pittsburgh		Pittsburgh	Pennsylvania	15224	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35293696	Derived	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.

ID	Term
D009136	Muscular Dystrophies
D020966	Muscular Disorders, Atrophic
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases