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

January 10, 2018 updated by: Actegy Ltd.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital, Bessemer Road, Denmark Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Aerosure 25 Hz
All subjects receive an active device, sham device (disabled) and no device in a randomised sequence.
Device: Aerosure 25 Hz
Active Aerosure device
SHAM_COMPARATOR: Aerosure sham
All subjects receive an active device, sham device (disabled) and no device in a randomised sequence.
Device: Aerosure Sham
Device designed to appear identical to active device but with HFAO mechanism disabled
NO_INTERVENTION: No device
All subjects receive an active device, sham device (disabled) and no device in a randomised sequence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Six minute walk distance (6MWD)
Time Frame: up to 6 minutes
up to 6 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
end-6MWD Borg breathlessness
Time Frame: after 6 minute walk test
after 6 minute walk test
Arterial oxygen saturation (SpO2)
Time Frame: At start of 6 minute walk test and after every 1 minute
At start of 6 minute walk test and after every 1 minute

Other Outcome Measures

Outcome Measure
Time Frame
Inspiratory capacity (IC)
Time Frame: At end of 6 minute walk test
At end of 6 minute walk test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actegy Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

December 6, 2013

First Submitted That Met QC Criteria

December 6, 2013

First Posted (ESTIMATE)

December 11, 2013

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2018

Last Update Submitted That Met QC Criteria

January 10, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 13.LO.1124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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