COPDACCORDNCT02007590
Aerosure and Six Minute Walk Distance in Severe COPD
A study testing Aerosure 25 Hz in people with COPD, run by Actegy Ltd. at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Aerosure 25 Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable severe COPD (FEV1 < 50% predicted)
- Modified MRC dyspnoea score 2 or greater
- At least 10 pack year smoking history
- Able to mobilise independently
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital, Bessemer Road, Denmark Hill
London, SE5 9RS
About this study
Official title: 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).
- Conditions
- COPD
- Being tested
- Aerosure 25 Hz, Aerosure Sham
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerosure 25 HzDevice
Active Aerosure device
Aerosure ShamDevice
Device designed to appear identical to active device but with HFAO mechanism disabled
| Study group | Role | What they receive |
|---|---|---|
| Aerosure 25 Hz | Experimental | All subjects receive an active device, sham device (disabled) and no device in a randomised sequence. Receives: Device: Aerosure 25 Hz |
| Aerosure sham | Sham comparator | All subjects receive an active device, sham device (disabled) and no device in a randomised sequence. Receives: Device: Aerosure Sham |
| No device | No intervention | All subjects receive an active device, sham device (disabled) and no device in a randomised sequence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walk distance (6MWD)
Measured: up to 6 minutes
Secondary outcomes (2)
end-6MWD Borg breathlessness
Measured: after 6 minute walk test
Arterial oxygen saturation (SpO2)
Measured: At start of 6 minute walk test and after every 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actegy Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Moxham, MD, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007590
- Sponsor's protocol ID
- 13.LO.1124
- Acronym
- ACCORD
- Status last verified
- Jan 2018
- First submitted
- 6 Dec 2013
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does High-frequency Airflow Oscillation, Delivered Using Aerosure, Increase Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease?
- ClinicalTrials.gov ID
- NCT02007590
- Acronym / sponsor ID
- ACCORD / 13.LO.1124
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Actegy Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerosure 25 Hz | Experimental | Device: Aerosure 25 HzAll subjects receive an active device, sham device (disabled) and no device in a randomised sequence. |
| Aerosure sham | Sham comparator | Device: Aerosure ShamAll subjects receive an active device, sham device (disabled) and no device in a randomised sequence. |
| No device | No intervention | –All subjects receive an active device, sham device (disabled) and no device in a randomised sequence. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stable severe COPD (FEV1 < 50% predicted)
- Modified MRC dyspnoea score 2 or greater
- At least 10 pack year smoking history
- Able to mobilise independently
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerosure 25 HzActive Aerosure device | Device | Aerosure 25 Hz |
| Aerosure ShamDevice designed to appear identical to active device but with HFAO mechanism disabled | Device | Aerosure sham |
Primary outcome
Six minute walk distance (6MWD)
Time frame: up to 6 minutes
2 secondary outcomes
end-6MWD Borg breathlessness
Time frame: after 6 minute walk test
Arterial oxygen saturation (SpO2)
Time frame: At start of 6 minute walk test and after every 1 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
Related trials for COPD
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Moxham, MD principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerosure 25 Hz in people with COPD, run by Actegy Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minute walk distance (6MWD) (time frame: up to 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.