Aerosure and Six Minute Walk Distance in Severe COPD

Not Applicable

Completed

• Conditions: COPD
• Interventions: Device: Aerosure Sham; Device: Aerosure 25 Hz

• Registration Number: NCT02007590
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-06
• Study First Posted: 2013-12-11
• Study Start: 2014-02
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-10
• Last Update Posted: 2018-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aerosure sham	Aerosure Sham	All subjects receive an active device, sham device (disabled) and no device in a randomised sequence.
Aerosure 25 Hz	Aerosure 25 Hz	All subjects receive an active device, sham device (disabled) and no device in a randomised sequence.

Primary Outcome Measures

Name	Time	Method
Six minute walk distance (6MWD)	up to 6 minutes

Secondary Outcome Measures

Name	Time	Method
end-6MWD Borg breathlessness	after 6 minute walk test
Arterial oxygen saturation (SpO2)	At start of 6 minute walk test and after every 1 minute

Trial Locations

Locations (1)

King's College Hospital, Bessemer Road, Denmark Hill; 🇬🇧 London, United Kingdom