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

Phase 2

Terminated

• Conditions: Cystic Fibrosis
• Interventions: Device: Aerosure at 15 Hz; Device: Sham Aerosure; Device: Aerosure at 25 Hz

• Registration Number: NCT01923753
• Lead Sponsor: Actegy Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-14
• Study First Posted: 2013-08-16
• Study Start: 2013-09
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-02
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aerosure 15 Hz	Aerosure at 15 Hz	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.
Aerosure sham	Sham Aerosure	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.
Aerosure 25 Hz	Aerosure at 25 Hz	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.

Primary Outcome Measures

Name	Time	Method
Wet weight of sputum expectorated during treatment session	up to 30 minutes after treatment

Secondary Outcome Measures

Name	Time	Method
Change in ventilation	5 minutes prior to treatment, immediately following treatment and 30 minutes after treatment
Change in FEV1	immediately before and up to 30 minutes after treatment
Change in VC	immediately before and up to 30 minutes after treatment
Change in oxygen saturation	continuously from 3 minutes prior to treatment and until 3 minutes after treatment
Change in neural respiratory drive	5 minutes prior to treatment and 30 minutes after treatment

Trial Locations

Locations (1)

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