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Aerosure and Six Minute Walk Distance in Severe COPD (ACCORD)

A

Actegy

Status

Completed

Conditions

COPD

Treatments

Device: Aerosure Sham
Device: Aerosure 25 Hz

Study type

Interventional

Funder types

Industry

Identifiers

NCT02007590
13.LO.1124

Details and patient eligibility

About

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).

Enrollment

42 patients

Sex

All

Ages

40+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

42 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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