Aerosure and Six Minute Walk Distance in Severe COPD

Does High-frequency Airflow Oscillation, Delivered Using Aerosure, Increase Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease?

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02007590

Acronym

ACCORD

Enrollment

Registered

2013-12-11

Start date

2014-02-28

Completion date

2017-12-31

Last updated

2018-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

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).

Interventions

DEVICEAerosure 25 Hz

Active Aerosure device

DEVICEAerosure Sham

Device designed to appear identical to active device but with HFAO mechanism disabled

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026