Aerosure and Six Minute Walk Distance in Severe COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aerosure 25 Hz

All subjects receive an active device, sham device (disabled) and no device in a randomised sequence.

Group Type EXPERIMENTAL

Aerosure 25 Hz

Intervention Type DEVICE

Active Aerosure device

Aerosure sham

All subjects receive an active device, sham device (disabled) and no device in a randomised sequence.

Group Type SHAM_COMPARATOR

Aerosure Sham

Intervention Type DEVICE

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

No device

All subjects receive an active device, sham device (disabled) and no device in a randomised sequence.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aerosure 25 Hz

Active Aerosure device

Intervention Type DEVICE

Aerosure Sham

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No