Aerosure and Six Minute Walk Distance in Severe COPD | NCT02007590

Studies
Aerosure and Six Minute Walk Distance in Severe COPD

NCT02007590

Sponsor

Actegy Ltd.

Status

Completed

Last Update Posted

Jan 11, 2018Actual

Enrollment

42Actual

Phase

Not Applicable

Conditions

COPD

Interventions

Aerosure 25 Hz
Aerosure Sham

Countries

United Kingdom

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 2018

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

Feb 2014

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Dec 6, 2013

First Submission Date that Met QC Criteria

Dec 6, 2013

First Posted Date

Dec 11, 2013Estimated

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

Jan 10, 2018

Last Update Posted Date

Jan 11, 2018Actual

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

To investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure, increases six minute walk distance (6MWD) and reduces exertional breathlessness in patients with severe chronic obstructive pulmonary disease (COPD).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aerosure 25 Hz	Experimental	All subjects receive an active device, sham device (disabled) and no device in a randomised sequence.	Device: Aerosure 25 Hz
Aerosure sham	Sham Comparator	All subjects receive an active device, sham device (disabled) and no device in a randomised sequence.	Device: Aerosure Sham
No device	No Intervention	All subjects receive an active device, sham device (disabled) and no device in a randomised sequence.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aerosure 25 Hz	Device	Active Aerosure device	Aerosure 25 Hz
Aerosure Sham

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Six minute walk distance (6MWD)		up to 6 minutes

Secondary Outcomes

Measure	Description	Time Frame
end-6MWD Borg breathlessness		after 6 minute walk test
Arterial oxygen saturation (SpO2)		At start of 6 minute walk test and after every 1 minute

Other Outcomes

Measure	Description	Time Frame
Inspiratory capacity (IC)		At end of 6 minute walk test

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stable severe COPD (FEV1 < 50% predicted)
Modified MRC dyspnoea score 2 or greater
At least 10 pack year smoking history
Able to mobilise independently

Exclusion Criteria:

Contraindications to spirometry [1]
Contraindications to clinical exercise testing [2]
Contraindications to HFAO (see section A.6.3b))
Resting SpO2>88% on air or on patient's usual oxygen prescription
Systolic arterial blood pressure (ABP) >200mmHg, diastolic ABP >100 mmHg
1. Cooper, B.G., An update on contraindications for lung function testing. Thorax, 2010.
2. ATS/ACCP Statement on Cardiopulmonary Exercise Testing. Am. J. Respir. Crit. Care Med., 2003. 167(2): p. 211-277.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Moxham, MD	King's College Hospital NHS Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King's College Hospital, Bessemer Road, Denmark Hill		London		SE5 9RS	United Kingdom

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

Browse Leaves

Not provided

Browse Branches

Not provided