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Completed

NCT Number: NCT02007590

Aerosure and Six Minute Walk Distance in Severe COPD

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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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King's College Hospital, Bessemer Road, Denmark Hill

London, SE5 9RS, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Treatment and study plan

Aerosure 25 Hz

Device

Active Aerosure device

Aerosure Sham

Device

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

Primary outcomes

  1. Six minute walk distance (6MWD)

    Time frame: up to 6 minutes

Secondary outcomes

  1. end-6MWD Borg breathlessness

    Time frame: after 6 minute walk test

  2. Arterial oxygen saturation (SpO2)

    Time frame: At start of 6 minute walk test and after every 1 minute

Other outcomes

  1. Inspiratory capacity (IC)

    Time frame: At end of 6 minute walk test

Sponsors and collaborators

Lead sponsor

Actegy Ltd.

Industry

Registry information

Official study title

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

Acronym: ACCORD

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2013
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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