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

Actegy

Status: Completed

Conditions: COPD

Treatments: Device: Aerosure Sham; Device: Aerosure 25 Hz

Study type: Interventional

Funder types: Industry

Identifiers

NCT02007590

13.LO.1124

Details and patient eligibility

About

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).

Enrollment: 42 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

42 participants in 3 patient groups

Aerosure 25 Hz

Experimental group

Description:

All subjects receive an active device, sham device (disabled) and no device in a randomised sequence.

Treatment:

Device: Aerosure 25 Hz

Aerosure sham

Sham Comparator group

Description:

All subjects receive an active device, sham device (disabled) and no device in a randomised sequence.

Treatment:

Device: Aerosure Sham

No device

No Intervention group

Description:

All subjects receive an active device, sham device (disabled) and no device in a randomised sequence.