Aerosure and Six Minute Walk Distance in Severe COPD

COPD Clinical Trial

— ACCORD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007590
• Other study ID #: 13.LO.1124
• Status: Completed
• Phase: N/A
• First received: December 6, 2013
• Last updated: January 10, 2018
• Start date: February 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Actegy Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Aerosure 25 Hz
Active Aerosure device
• Aerosure Sham
Device designed to appear identical to active device but with HFAO mechanism disabled

Locations

Country	Name	City	State
United Kingdom	King's College Hospital, Bessemer Road, Denmark Hill	London

Sponsors (1)

Lead Sponsor	Collaborator
Actegy Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inspiratory capacity (IC)		At end of 6 minute walk test
Primary	Six minute walk distance (6MWD)		up to 6 minutes
Secondary	end-6MWD Borg breathlessness		after 6 minute walk test
Secondary	Arterial oxygen saturation (SpO2)		At start of 6 minute walk test and after every 1 minute