Aerosure and Six Minute Walk Distance in Severe COPD
ACCORD
Does High-frequency Airflow Oscillation, Delivered Using Aerosure, Increase Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease?
1 other identifier
interventional
42
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 11, 2018
January 1, 2018
3.8 years
December 6, 2013
January 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Six minute walk distance (6MWD)
up to 6 minutes
Secondary Outcomes (2)
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 (1)
Inspiratory capacity (IC)
At end of 6 minute walk test
Study Arms (3)
Aerosure 25 Hz
EXPERIMENTALAll subjects receive an active device, sham device (disabled) and no device in a randomised sequence.
Aerosure sham
SHAM COMPARATORAll subjects receive an active device, sham device (disabled) and no device in a randomised sequence.
No device
NO INTERVENTIONAll subjects receive an active device, sham device (disabled) and no device in a randomised sequence.
Interventions
Device designed to appear identical to active device but with HFAO mechanism disabled
Eligibility Criteria
You may qualify if:
- Stable severe COPD (FEV1 \< 50% predicted)
- Modified MRC dyspnoea score 2 or greater
- At least 10 pack year smoking history
- Able to mobilise independently
You may not qualify if:
- 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
- Cooper, B.G., An update on contraindications for lung function testing. Thorax, 2010.
- ATS/ACCP Statement on Cardiopulmonary Exercise Testing. Am. J. Respir. Crit. Care Med., 2003. 167(2): p. 211-277.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Actegy Ltd.lead
Study Sites (1)
King's College Hospital, Bessemer Road, Denmark Hill
London, SE5 9RS, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Moxham, MD
King's College Hospital NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2013
First Posted
December 11, 2013
Study Start
February 1, 2014
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
January 11, 2018
Record last verified: 2018-01