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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-11-30

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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aerosure 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.

Group Type EXPERIMENTAL

Aerosure at 15 Hz

Intervention Type DEVICE

Active Aerosure HFAO device operating at lower frequency

Aerosure 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.

Group Type ACTIVE_COMPARATOR

Aerosure at 25 Hz

Intervention Type DEVICE

Active Aerosure HFAO device operating at higher frequency

Aerosure sham

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.

Group Type SHAM_COMPARATOR

Sham Aerosure

Intervention Type DEVICE

Deactivated but identical Aerosure HFAO device

Interventions

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Aerosure at 15 Hz

Active Aerosure HFAO device operating at lower frequency

Intervention Type DEVICE

Aerosure at 25 Hz

Active Aerosure HFAO device operating at higher frequency

Intervention Type DEVICE

Sham Aerosure

Deactivated but identical Aerosure HFAO device

Intervention Type DEVICE

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No