A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis

Actegy

Status and phase: Terminated; Phase 2

Conditions: Cystic Fibrosis

Treatments: Device: Aerosure at 25 Hz; Device: Aerosure at 15 Hz; Device: Sham Aerosure

Study type: Interventional

Funder types: Industry

Identifiers

NCT01923753

ACACIA-01

Details and patient eligibility

About

This is a double-blind randomised controlled crossover study to investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure, improves sputum clearance in patients admitted to hospital with infective exacerbations of cystic fibrosis (CF). This study will test the hypothesis that the wet weight of sputum expectorated is greater following the use of Aerosure than following the use of a sham Aerosure device.

Enrollment: 6 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A diagnosis of CF (established by genotype or sweat sodium >70mmol/l or sweat chloride of >60 mmol/l
• Admitted to King's College Hospital within 48 hours of an acute infective pulmonary exacerbation characterised by an increase in respiratory symptoms requiring intravenous antibiotics

Exclusion criteria

• Acute respiratory failure
• Haemodynamic instability (including severe right heart failure with hypotension)
• Current severe haemoptysis
• Ineffective cough
• Rib fractures
• Pregnancy
• Current or recent pneumothorax
• Epilepsy
• Current pulmonary embolism
• Oesophageal varices
• Recent thoracic upper gastro-intestinal tract or facial surgery
• Active tuberculosis
• Recent brain, eye, ear, ENT surgery
• Myocardial infarction
• Ascending aortic aneurysm
• Acute diarrhoea
• Pulmonary embolism
• Angina
• Severe hypertension (systolic >200 mm Hg, diastolic >120 mm Hg)
• Confusion/dementia
• Inability to give consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

6 participants in 3 patient groups

Aerosure 15 Hz

Experimental group

Description:

All subjects receive an active device operating at a specific frequency, active device operating at another specific frequency and sham device (disabled): Aerosure at 15 Hz; Aerosure at 25 Hz; Sham Aerosure. Order of presentation is randomised.

Treatment:

Device: Aerosure at 15 Hz

Aerosure 25 Hz

Active Comparator group

Description:

All subjects receive an active device operating at a specific frequency, active device operating at another specific frequency and sham device (disabled): Aerosure at 15 Hz; Aerosure at 25 Hz; Sham Aerosure.

Treatment:

Device: Aerosure at 25 Hz

Aerosure sham

Sham Comparator group

Description:

All subjects receive an active device operating at a specific frequency, active device operating at another specific frequency and sham device (disabled): Aerosure at 15 Hz; Aerosure at 25 Hz; Sham Aerosure.

Treatment:

Device: Sham Aerosure