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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Device: Aerosure at 15 Hz
* Device: Aerosure at 25 Hz
* Device: Sham Aerosure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerosure 15 Hz<br>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. | Device: Aerosure at 15 Hz<br>* Active Aerosure HFAO device operating at lower frequency<br>|
| Active Comparator: Aerosure 25 Hz<br>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. | Device: Aerosure at 25 Hz<br>* Active Aerosure HFAO device operating at higher frequency<br>|
| Sham Comparator: Aerosure sham<br>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. | Device: Sham Aerosure<br>* Deactivated but identical Aerosure HFAO device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wet weight of sputum expectorated during treatment session |  | up to 30 minutes after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 ventilation |  | 5 minutes prior to treatment, immediately following treatment and 30 minutes after treatment | 
| Change in neural respiratory drive |  | 5 minutes prior to treatment and 30 minutes after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Neural respiratory drive, Airway clearance technique, Expectoration, Positive expiratory pressure device