Efficacy of High Flow Therapy in COPD At Home | NCT02230020

Studies
Efficacy of High Flow Therapy in COPD At Home

NCT02230020

Sponsor

Johns Hopkins University

Status

Terminated

Last Update Posted

Aug 8, 2017Actual

Enrollment

8Actual

Phase

Not provided

Conditions

COPD

Interventions

Nasal High Flow

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

Aug 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor funding

Expanded Access Info

Start Date

Aug 15, 2013Actual

Primary Completion Date

Dec 13, 2015Actual

Completion Date

Dec 13, 2015Actual

First Submitted Date

Aug 29, 2014

First Submission Date that Met QC Criteria

Aug 29, 2014

First Posted Date

Sep 3, 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

Aug 7, 2017

Last Update Posted Date

Aug 8, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Preliminary data show that in COPD patients, HFT substantially decreases ventilatory demand during sleep. The central hypothesis of this proposal is that lowering ventilatory demand using nasal high-flow therapy during sleep will elevate lung function, reduce dyspnea on exertion and improve quality of life. Thus, this proposal aims will determine the effects HFT over time on 1) lung function; 2) dyspnea on exertion; and 3) quality of life.

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

Retention

Enrollment

8Actual

Label	Type	Description	Intervention Names
Nasal High Flow		All subjects are in this group	Device: Nasal High Flow

Name	Type	Description	Arm Group Labels	Other Names
Nasal High Flow	Device		Nasal High Flow

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lung Function	Spirometry will be performed before and after each sleep study	Baseline and 1 month
Dyspnea score	Borg scale score before and after each sleep study	Baseline and 1 month
Sleep quality	Sleep architecture assessed from sleep studies	Baseline and 1 month
Quality of life	St Georges Respiratory Questionnaire Hopkins Sleep Survey MRC Breathlessness Scale UCSD Shortness of Breath	Baseline and 1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Consenting adults over the age of 18 with COPD

Exclusion Criteria:

1. Apnea Hypopnea Index>15 events/hr 2. Use of Non-invasive positive pressure ventilation (CPAP + Bilevel) 3. Severe bilateral nasal obstruction (apparent mouth breathing at rest) 4. Documented clinical cardiovascular disease, as defined below:
1. myocardial infarction in past 3 months
2. revascularization procedure in past 3 months
3. implanted cardiac pacemaker or ICD
4. unstable arrhythmias
5. congestive heart failure with ejection fraction < 40%
6. uncontrolled hypertension (BP > 190/110) 5. History of end stage renal disease (on dialysis) 6. History of end stage liver disease, such as:
1. Jaundice
2. ascites
3. history of recurrent gastrointestinal bleeding
4. transjugular intrahepatic portosystemic shunt (TIPS) ; 7. Transportation industry worker (commercial truck or bus drivers, airline pilots) 8. Known pregnancy (by self report) 9. Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin. 10. Do you take medications for any of the following reasons:
1. Pain control (besides NSAIDs)
2. Sleep medication
3. Benzodiazepines
4. Methadone

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Chronic Obstructive Pulmonary Disease

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Jason Kirkness, PhD	Johns Hopkins University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins University		Baltimore	Maryland	21224	United States

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

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Browse Branches

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