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

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ClinicalTrials.gov Identifier: NCT02007590
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Actegy Ltd.

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).

Condition or disease Intervention/treatment Phase
COPD Device: Aerosure 25 Hz Device: Aerosure Sham Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Does High-frequency Airflow Oscillation, Delivered Using Aerosure, Increase Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease?
Study Start Date : February 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

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.



Primary Outcome Measures :
  1. Six minute walk distance (6MWD) [ Time Frame: up to 6 minutes ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Inspiratory capacity (IC) [ Time Frame: At end of 6 minute walk test ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007590


Locations
United Kingdom
King's College Hospital, Bessemer Road, Denmark Hill
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Actegy Ltd.
Investigators
Principal Investigator: John Moxham, MD King's College Hospital NHS Trust

Responsible Party: Actegy Ltd.
ClinicalTrials.gov Identifier: NCT02007590     History of Changes
Other Study ID Numbers: 13.LO.1124
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018